Quality Control Supervisor

Analytical Quality Assurance Specialist

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Senior Packaging Technician

Manufacturing Operator II

Reliability Technician

Associate I, Quality Operations

Specialist, DEA Compliance

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>Material/Product Review &amp; Release:</li><li>Review raw material and finished product testing result records, including Certificates of Analysis (C of A), Certificates of Conformance (C of C), and laboratory reports to confirm accuracy.&nbsp;&nbsp;</li><li>Determine the acceptability of materials/products for release based on compliance with specifications and testing results.&nbsp;&nbsp;</li><li>Perform ERP transactions for the release, hold, or rejection of raw materials and finished products.&nbsp;&nbsp;</li><li>Prioritize raw material review and release based on production scheduling requirements.&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Minimum 5-12 years of experience in the pharmaceutical industry related to material/product review, release, and laboratory functions.&nbsp;&nbsp;</li><li>Expertise in reviewing and managing GMP documents, raw material and product testing, and quality systems.&nbsp;&nbsp;</li><li>Proficiency with laboratory systems and software tools such as LIMS, SAP, and EMPOWER.&nbsp;&nbsp;</li><li>Strong understanding of regulatory guidelines, including FDA, EMA, and ICH, as well as industry standards and best practices.&nbsp;&nbsp;</li></ul>

Job Description: <ul><li>We are seeking a highly motivated Scheduling &amp; Production Planning Analyst with expertise in inventory management and advanced Excel modeling skills.</li><li>The ideal candidate will have 2-3 years of experience in scheduling, production planning, and inventory management, with a strong ability to leverage Excel to optimize processes and improve efficiency.</li><li>A background in finance is an added advantage, helping to drive decisions on new business opportunities, cost analysis and budget management within production and inventory functions.</li><li>In this role, you will be responsible for developing and managing production schedules, optimizing inventory levels, forecasting demand, and analyzing data to support decision-making.&nbsp;</li><li>Your advanced Excel skills will be crucial in creating models for production, inventory planning, and reporting, while your understanding of finance will help identify cost-optimization opportunities.</li></ul> Responsibilities: Production Scheduling &amp; Planning: <ul><li>Develop and manage production schedules, ensuring efficient resource allocation (labor, equipment, raw materials) and meeting production deadlines. Work closely with cross-functional teams to align production goals with business objectives.</li></ul> Inventory Management: <ul><li>Monitor inventory levels and ensure alignment with production schedules.&nbsp;</li><li>Optimize inventory to minimize holding costs and reduce the risk of stockouts or overstock situations.</li></ul> <ul><li>Advanced Excel Modeling: </li></ul> <ul><li>Utilize advanced Excel skills to build and maintain models for production planning, inventory optimization, and scheduling. </li><li>This includes using pivot tables, complex formulas, forecasting, data visualization, and macros to enhance decision-making and operational efficiency.</li></ul> Forecasting &amp; Demand Planning: <ul><li>Work with sales, procurement, and other teams to develop accurate demand forecasts, ensuring production schedules are aligned with customer needs and market trends.</li></ul> Capacity &amp; Resource Planning: <ul><li>Analyze production capacity and resource availability, adjusting schedules and inventory management to meet changing demands and operational constraints.</li></ul> Cost Management &amp; Financial Analysis: <ul><li>Collaborate with finance teams to monitor production and inventory costs, identify inefficiencies, and help with cost optimization strategies.&nbsp;finance background will assist in budgeting and forecasting for production-related topics.</li></ul> Performance Reporting: <ul><li>Prepare and present regular reports on production performance, inventory levels, and key performance indicators (KPIs). Provide data-driven insights and recommendations to improve efficiency, reduce costs, and meet business goals.</li></ul> Process Optimization: <ul><li>Continuously assess and refine production planning, scheduling, and inventory management processes. Recommend and implement improvements to reduce waste, increase throughput, and optimize resource utilization.</li></ul> ERP System Utilization: <ul><li>Use ERP systems (SAP) to manage production and inventory data, ensuring accurate tracking of orders, materials, and resources.</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain management, Operations, Business, Finance, or a related field.</li><li>2-3 years of experience in scheduling, production planning, and inventory management.</li><li>Advanced proficiency in Microsoft Excel, including pivot tables, VLOOKUP, advanced formulas, forecasting models, macros, and data analysis.</li><li>Strong understanding of production scheduling, inventory management, and supply chain processes.</li><li>A background in finance or financial analysis is an added advantage, helping to identify cost-optimization opportunities and manage budgets effectively.</li><li>Familiarity with ERP systems (e.g., SAP) and other inventory management tools.</li><li>Strong analytical skills and the ability to interpret complex data and generate actionable insights.</li><li>Excellent communication and collaboration skills, with the ability to work cross-functionally with teams across the organization.</li><li>Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.</li></ul> Preferred Qualifications: <ul><li>Certification in Supply Chain Management or Finance-related qualifications (e.g., MBA) is a plus.</li><li>Experience with data visualization tools (e.g., Power BI, Tableau) for reporting and dashboard creation.</li><li>Knowledge of production planning software or inventory management systems is beneficial.</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</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>

Responsibilities: <ul><li>Coordinates each Operator’s responsibilities during each shift.</li><li>Monitors the packaging process to ensure schedule is met within standards.</li><li>Conducts final audit of Batch Records, including MAPICS transactions, prior to going to Packaging BR Reconciler; Is qualified and capable of running all packaging equipment across the entire packaging department.</li><li>Conducts preliminary review of all daily Batch Production Record (BPR) for the line and logbook documentation to ensure detail and accuracy.</li><li>Accurately reviews BPRs steps for completeness and accuracy.</li><li>Request components, labels and inserts per the BPR.</li><li>Set up packaging machinery; accurately sets equipment programming according to BPRs and SOPs.</li><li>Conduct basic set ups, starts, operates, adjusts, troubleshoots and tears down packaging lines.</li><li>Conduct sampling: Collects samples from each batch and submits to QA for retained samples.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li><li>Conducts verification of line/equipment cleaning and documents per SOP.</li><li>Executes procedures used to clean pharmaceutical packaging equipment and facilities.</li><li>Competently conducts Master Cleans and Line Clearances.</li></ul> Requirements: <ul><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>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Responsibilities: <ul><li>Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, potent compound, etc.&nbsp;</li><li>Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.</li><li>Executes written SOPs to ensure the purity of materials involved in the manufacturing process.</li><li>Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.</li><li>Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.</li><li>Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.</li><li>Executes machine change-overs from batch to batch.</li><li>Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator.</li><li>Learns sampling techniques.</li><li>Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debriefing session to understand the reasons why and what needs to be corrected moving forward.</li><li>Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.</li><li>Meets requirements for entries on all applicable batch production pages, completion and attachment of all dispensary and weight verification tickets.</li><li>Verifies the manufacturing process on BPR in an accurate and timely manner.</li><li>Provides status updates and operational challenges on status boards.</li></ul> Requirements: <ul><li>HS diploma or equivalent at minimum, with 0-2 years’ related experience*</li><li>Forklift certification may be required for blending and granulation.</li><li>Knowledge of cGMPs.</li><li>Has solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.&nbsp;&nbsp;</li><li>Basic math, reading, legible writing skills, and problem solving abilities.&nbsp;</li></ul>

Responsibilities:The Technician III, Reliability performs facility reliability maintenance activities in accordance with approved procedures requiring limited supervision. Proficient at analyzing and troubleshooting the root cause of facility, manufacturing and packaging equipment problems. Implements effective preventive and/or corrective maintenance repairs to provide increased reliability. Identifies maintenance improvements that increase efficiency, throughput, and quality. May train others in setting up equipment. Identifies and solves complex problems. Understands the practical application to problems and situations ordinarily encountered and makes decisions that require choosing from several options.Requirements:May be required to be proficient in troubleshooting & repair in 4 or more of the following areas:ElectricalHydraulicsPneumaticsMechanicalPLC'sProficient in following areas:Ability to read and follow blueprints and engineered drawings.Ability to use theBMS (Bldg. Management System) for HVACSpecialized in at least 4 of the following 5 areas:Utility – purified water systems, compressed air, boiler, chilled water, electrical distribution, product dust collection systems.Building Maintenance – sewers, electronic card readers (when applicable), lighting.Fire suppression systems.HVAC competence and certification, as required.General building & grounds maintenance.Basic math, writing skills, problem solving.Basic computer skills.Ability to use hand tools.Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions.Basic math, writing skills, problem solving.Education & Experience:A High School Diploma or equivalent is required.Level 3 TechSeven years related experience and certification in assigned area(s), as required.ACCP-Level II Certification or equivalent experience

Responsibilities:The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.Communicates to multiple departments and supervision to provide timely process and issue updates.Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.Participates in reviews and structured processes for continuous improvement.  Quality Operations:Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substances.Performs GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databases.Collects retain samples and performs sample evaluation for Annual Product Review.May backup third party product review/release.Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.Non-conforming events:Responds to and escalates events identified during production to Quality Management.Participates in investigations with the Rapid Response Team as needed.Process Improvement:Collaborates with Manufacturing and Quality partners to identify and implement improvements.Compliance:Conducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BR requirements.Actively participates in training events, and maintains currency with assigned training requirements.Safety:Follows all procedures to ensure a safe and compliant work environment.Requirements:Education & Experience:High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Ability to communicate and work with teams.Attention to detail.Strong documentation skills.Ability to read and interpret SOPs and function within the scope of procedures.

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

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12 chestnut ridge Jobs found

Quality Control Supervisor

Analytical Quality Assurance Specialist

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Senior Packaging Technician

Manufacturing Operator II

Reliability Technician

Associate I, Quality Operations

Specialist, DEA Compliance

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12 chestnut ridge Jobs found

Quality Control Supervisor

Analytical Quality Assurance Specialist

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Senior Packaging Technician

Manufacturing Operator II

Reliability Technician

Associate I, Quality Operations

Specialist, DEA Compliance

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WhiteCrow is on a mission to connect companies with the best talent across the globe.