Operations Supervisor

Mold Maintenance Engineer

Project Engineer – PCIS – GL1

Quality Control Supervisor

Senior Quality Engineer

Manager, Manufacturing & Process Development for High-Speed Cable Assemblies

Payroll Analyst

Operation Supervisor

Lead Quality Specialist - Investigator

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul>

Responsibilities: Production Data Records: <ul><li>In order to ensure the accuracy, timeliness and effectiveness of production data, fill in the production data truthfully and record on-site reports.</li></ul> Mold Repair &amp; Maintenance: <ul><li>In order to ensure the normal operation of molding production, repair and maintain molds in a timely manner according to production problems, and do a proper job in mold inventory management and preparation for transfer orders.</li></ul> Workshop Safety Management &amp; EHS: <ul><li>To ensure the safety of the production environment, implement safety production regulations and implement 5S+1 management.</li><li>Strictly abide by the companys labor discipline, safe operating procedures and various EHS rules and regulations at work, and strictly implement job safety responsibilities.</li><li>Receive various EHS trainings, actively participate in various EHS activities, save energy, reduce the use of hazardous waste, strictly implement the companys accident reporting system, and actively participate in and complete departmental EHS target indicators.</li></ul> Spare Parts Management: <ul><li>In order to ensure the normal production of molds, monitor the consumption of spare parts in stock, apply for and follow up on parts in a timely manner, and control parts consumption.</li></ul> New Mold Assembly: <ul><li>In order to meet the delivery requirements and needs of new projects, we resolutely implement the production plan for new mold assembly and complete the assembly of new molds on time.</li></ul> Requirements: Education, Technical Qualification &amp; Experience: <ul><li>Bachelor in Mechanical Engineering major or Industrial Engineering</li><li>3-5+ years’ experience and practitioner in the Tooling Design &amp; Development</li><li>CAD Knowledge Must, preferably Pro E / Creo &amp; Auto-cad, Solidworks, NX, etc.</li></ul>

Responsibilities: <ul><li>PC&amp;IS Project for Process and Packing equipment power electrical system.</li><li>Support the local project team during the greenfield/brownfield site development as well as during projects executed in current facilities (locally)</li><li>Support global standard for projects with regards to:</li><li>Lead implementation and integration of equipment control systems&nbsp;</li><li>Support development of program platform for PLC and HMI for future projects&nbsp;</li><li>Implement Motor control center, and PLC control structure and execution strategy.</li><li>Implement site Digitization and Smart Factory system (equipment &amp; utilities)</li><li>Lead the vendor selection process for the various PC&amp;IS tasks with approval from line manager.</li><li>Oversee electrical installation of all equipment aspects</li><li>Ensure power &amp; utilities authority works in place and handled in compliance</li><li>Act as key representative to of the company technical service team in terms of all electrical and controls matter (utilities, electrical design and installation)</li><li>Projecting multilayer network solution for information system.</li><li>Liaising with multiple vendors for project execution.</li><li>Liase with company global engineering and central functions (EHS, GRC, QFS) to ensure compliance in all aspects</li><li>COP support for operation support in implementing electrical project handover and electrical spare part inventory.</li><li>COP support for electrical &amp; control modification for upgrading projects. Supporting operation &amp; engineering team for electrical related solution.</li><li>Build capability among the technical service team and relevant Plant resources.</li><li>Active participation in the Implementation of the company Work System (KWS) from a support perspective especially with regard to the Technical COE and has a thorough understanding of its content &amp; process.&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Minimum college graduate or completed electrical apprenticeship and attended professional training</li><li>Minimum 2 years of field experience and electrical, control, process &amp; instrumentation aspect.</li><li>Candidates preferred with experience with food processing PC&amp;IS design, implementation &amp; integration, construction and start-up&nbsp;</li><li>Experience in Equipment/Utilities interface design and control systems (Rockwell/ Wonderware/ OSI platform)</li><li>experience in Leading and building capability Typically works independently with some direction from Manager.</li><li>Responsible for own work. Supervision of supporting team members during project execution.</li><li>Travel may be required. In the Asia Pacific Region unless assigned to a location for a project duration.</li><li>Be physically fit and able to travel and work safely on Construction sites.</li><li>Work is performed in area with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear.</li><li>Equipment - Electrical &amp; instrument used in production lines &amp; utilities.</li><li>Laptop &amp; softwares - Engineering laptop &amp; softwares. Best if the candidates has some knowledge on any of below:</li><li>Rockwell Studio 5000, Rockwell Panel View, OsiSoft Tools, SQL Server Management Studio, Javascript in SAP xMii, AutoCAD, softwares.</li><li>Public contact – Electrical contractors, system integrators, electrical suppliers and vendors.</li><li>Safety of all employees is paramount; therefore the incumbent and their reports must work safely and ensure compliance with all local, state and federal policies and legislation (Work Cover, DECC, Environmental etc).</li><li>Adherence to company policies and procedures is also required.&nbsp;</li><li>Company’s reputation is held in high regard, the incumbent will work in an environment that prides itself on protecting this reputation by ensure our products are of premium quality to maintain customer satisfaction.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Develop and implement quality standards to meet Quality Management System to assure products meet or exceed customer expectations.</li><li>Lead cross-functional problem-solving teams; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions</li><li>Performs routine supplier and plant audits to ensure product being manufactured meets all requirements.</li><li>Lead cross-functional teams to drive process and product improvements in manufacturing plants and at suppliers.</li><li>Work with Manufacturing, Engineering, and PM to determine product specifications and tolerances.</li><li>Participates in various NPI projects to ensure quality is incorporated into product designs and be responsible for preparing all quality-related documentation.</li><li>Support the development of FMEAs, Control Plans, Test and Inspection Plans.</li><li>Establish and maintain control plans to assure critical features are controlled through manufacturing processes.</li><li>Reviews and integrates contractual requirements into all aspects of proposals and program processes and documentation.</li><li>Conducts capability assessments and process validations to support supplier selection activities.</li><li>Provides material review dispositions for non-conforming materials or products.</li><li>Plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables.</li><li>Update company complaint handling system to ensure capture, investigation, and proper documentation of all customer complaints.</li><li>Manage documents related to ISO certification, procedures, standards, customer change requests, ECN, PCN, and/or Work Instructions.</li></ul> Requirements: <ul><li>Bachelor’s degree, Engineering or related technical discipline.</li><li>8+ years’ experience in Quality Engineer role in a production environment.</li><li>Familiarity with ISO 9001, AS9100 or ISO/TS 16949 QMS standards.</li><li>Experience in reading blueprints and have basic understanding of GD&amp;T fundamentals.</li><li>Experience effectively utilizing statistical methods and statistical analysis tools.</li><li>Experience with APQP, PPAP, FMEA, Control Plans, and various problem solving tools.</li><li>Experience in statistical tools and disciplined problem-solving methodologies such as 8D, A3, DMAIC, Fishbone,5-Whys, 6Ms.</li><li>Self-motivated, proactive and efficient team player who thrives in a fast-paced environment.</li><li>Able to travel 20% - 30% domestically and 10% internationally.</li><li>Must be eligible to work in the US with no sponsorship now or in the future.</li><li>Technical understanding of electrical power systems and electrical power distribution/circuit protection products.</li><li>Six Sigma Green, Black Belt, or comparable certification, preferred.</li><li>Excellent communication skills written, verbal, and presentation skills with effective technical writing skills, ability to speak Spanish is a plus.</li><li>High-energy, results-oriented, self-reliant, team player who can positively collaborate across different business departments and cultures.</li><li>Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)</li><li>Experience in the electrical-mechanical manufacturing or solar industry.</li><li>Experience in conducting supplier and plant audits.</li><li>Experience in reviewing customer contracts.</li></ul>

Responsibilities: Lead a team of engineers who will: <ul><li>Develop cable assembly processes and production lines in accordance with LEANPD product development</li><li>Drive for excellence in existing high speed cable assembly lines</li><li>Strive to reduce line startup and eliminate defects.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for high volume manufacturability; realizes proof of concept tooling, product samples and prototypes.</li><li>Design, develop, and qualify tooling and processes to meet our client Digital Data Networks quality and production standards.</li><li>Support supply chain to verify supplier compliance and capability.</li><li>Act as the binding element between product development and cable assembly engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with project management team to understand current and future strategic business needs</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need</li><li>Provide readouts to Director and VP level cross function management as necessary</li><li>Work with Hermosillo operations team to assign resources necessary for the successful execution of new high-speed cable production</li><li>Facilitate and coordinate cross-function communication across globally matrixed organization</li></ul> Requirements: <ul><li>Bachelor or above degree with mechanical/electric related majors;</li><li>At least 5 years related experience managerial level in multinational manufacturing site;</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools;</li><li>With 2 years or above work experience in high-speed cable assembly production is required</li><li>Fluent in English and good presentation skills;</li><li>Familiar with MS software;</li><li>Familiar with industrial specification (i.e. IPC 620)</li></ul>

Responsibilities:&nbsp; <ul><li>Provide effective and efficient on-site Payroll service ,contribute in company Philippine payroll and related programs (eg. tax, insurance, labor cost report, benefit programs) processing within established budgets, principles and regulations, laws and employment standards , manage the accurate and timely processing of payroll related activities.&nbsp;</li><li>Work with plant operations and T&amp;A colleague to ensure time &amp; attendance data smoothly flow into payroll process and ensure payroll accuracy&nbsp;</li><li>Responsible to employee’s query about payroll&nbsp;</li><li>Responsible to payroll related files documentation and ensure meet audit requirement&nbsp;</li><li>Act as advisor to business on country policies, local regulations and company policies, keep abreast of all Payroll regulatory related issues, foresee potential risk vs current practice and raise for discussion, drive for risk elimination to ensure compliance&nbsp;</li><li>Support HRBP to develop site pay policy/procedures</li><li>Responsible for audits and ensure accuracy and data integrity, implement related action plan as audit needs&nbsp;</li><li>Continuously review and enhance payroll processes/programs and implement improvement, manage global or regional payroll integration or harmonization program, promote global or regional payroll system at site and ensure the adoption rate .</li><li>Provide on-site HR services operations assigned by manager.</li></ul> Requirements: <ul><li>Bachelor’s degree, human resources education or equivalent&nbsp;</li><li>7 years progressive payroll experience as independent Payroll Analyst&nbsp;</li><li>Familiarity with PH agencies such as SSS, PhilHealth, and Pag-ibig, as well as tax regulations (BIR).</li><li>Working experience in international enterprise&nbsp;</li><li>Good knowledge of country and local Payroll laws&nbsp;</li><li>Breadth of experience in Payroll disciplines, including data management, metrics and measurement&nbsp;</li><li>Proficient in MS Office (incl. Word, Excel and PowerPoint)&nbsp;</li><li>Experience with tax systems and reporting&nbsp;</li><li>Good service mindset and collaboration spirit&nbsp;</li><li>Experience with time and attendance systems preferred</li></ul>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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23 site investigation Jobs found

Operations Supervisor

Mold Maintenance Engineer

Project Engineer – PCIS – GL1

Quality Control Supervisor

Senior Quality Engineer

Senior Quality Engineer

Manager, Manufacturing & Process Development for High-Speed Cable Assemblies

Payroll Analyst

Operation Supervisor

Lead Quality Specialist - Investigator

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23 site investigation Jobs found

Operations Supervisor

Mold Maintenance Engineer

Project Engineer – PCIS – GL1

Quality Control Supervisor

Senior Quality Engineer

Senior Quality Engineer

Manager, Manufacturing & Process Development for High-Speed Cable Assemblies

Payroll Analyst

Operation Supervisor

Lead Quality Specialist - Investigator

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