Lead Quality Specialist - Investigator

Manufacturing Engineer - Injection Molding

Test Laboratory Engineer

Fiber Optic Product Development Engineer

Associate I, Quality Operations

Specialist, DEA Compliance

QC Chemist I

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>Provide feedback to Product Engineering where design issues exist that limit quality, reliability, or keep cost targets from being met.</li><li>Work to develop, improve, and implement safety controls in manufacturing</li><li>Support business unit initiatives for cost out, materials, and process productivity</li><li>Ability to proactively drive projects with minimal guidance or supervision</li><li>Responsible for all aspects of tooling and process development: concept, quoting, purchasing, design reviews, build, conditioning, validation, approval, and production release</li><li>Design and complete capability studies/process and tooling validations to ensure capable processes.&nbsp;</li><li>Familiarity with measurement system analysis tools is preferred.&nbsp;</li><li>Work with the New Product Design team on new programs, ensuring design for manufacturability and design for automation opportunities</li><li>Ensure product, tooling, and process documentation meet all our client Quality and Engineering system requirements</li><li>Evaluate and recommend changes to existing mold tooling and tooling design to ensure that manufacturing capabilities meet the maximum capacity and cost objectives for the business unit</li><li>Initiate and review design and mold constructions and significant modifications.</li><li>Implement a controlled process to collaborate with Product Engineering on pending design changes.</li><li>Work with the Global Molding Center Of Excellence and ensure deployment across the Business Unit.</li><li>Participate in management meetings to identify standard process approaches and to identify key technology needs to reduce costs or capture new markets.&nbsp;</li><li>Responsibilities are subject to change based on Manufacturing needs.</li></ul> Requirements: <ul><li>Bachelor’s Degree in Engineering.</li><li>3-5 years of Engineering/Technical experience in a manufacturing environment.</li><li>Must have knowledge of molding process theory, engineering grade resins, and auxiliary equipment.</li><li>Capable of taking molding projects from concept through approval.</li><li>RJG Methodology a Plus.</li><li>Understanding of core processes (i.e., molding, stamping, plating, assembly)</li><li>Proven and practical problem-solving skills and attention to detail.</li><li>Self-directed and highly motivated</li><li>Excellent written, verbal, and presentation skills; Confidence and ability to effectively communicate</li><li>Must be willing and able to travel both domestically and globally as required (Travel &lt;10%)</li><li>Must be willing to participate in teleconference meetings to accommodate other time zones</li><li>Able to evaluate product function and be able to make material recommendations to product engineering</li><li>Working knowledge of LEAN and Six Sigma principles is a plus.</li><li>Strong computer skills (CREO, CAD, project management, word processing, spreadsheets)&nbsp;</li><li>Must be proficient in the English language</li></ul> What your background should look like: <ul><li>Must be willing to participate in teleconference meetings to accommodate other time zones</li><li>Able to evaluate product function and be able to make material recommendations to product engineering</li><li>Working knowledge of LEAN and Six Sigma principles is a plus.</li><li>Strong computer skills (CREO, CAD, project management, word processing, spreadsheets)&nbsp;</li><li>Must be proficient in the English language</li></ul> Competencies: <ul><li>Values: Integrity, Accountability, Inclusion, Innovation, Teamwork</li></ul>

Responsibilities : <ul><li>Conduct electrical, mechanical, and environmental testing on our client products for the purpose of Engineering Evaluation and Qualification.</li><li>Prepare samples using hand tools and soldering.</li><li>Run a variety of computer and microprocessor-controlled test equipment.</li><li>Set-up &amp; operate environmental, mechanical and electrical test equipment</li><li>Review and summarize data.</li><li>Maintain the integrity of test results by complying with Corporate, Business Unit and local quality system requirements.</li><li>Review active test programs and final test results to ensure that performance requirements are met.</li><li>Capable of working to specifications, drawings, diagrams, and schematics.</li><li>Ensure all safety requirements are met and followed</li><li>Write test documentation and reports.</li><li>Perform other duties as assigned by management.</li><li>Overtime or temporary shift in hours may be required at times to support high priority business needs.</li></ul> Requirements : <ul><li>A preferred candidate should have, or be actively pursuing, an HNC or equivalent in Electronic or Mechanical Engineering, or have 3-5 years’ experience in testing.</li><li>Background of mechanical experience to aid fixture design and construction.</li><li>Good soldering skills and manual dexterity.</li><li>Hands on experience for tearing apart assemblies / sub-assemblies of electro mechanical parts</li><li>Good Conceptual, problem solving and Analytical Skills</li><li>Excellent verbal and written communication skills.</li><li>Excellent attention to detail</li><li>Knowledge of Six Sigma tools will be an added advantage</li><li>Proficient in MS Office Suite</li><li>Ability to work in a hands-on environment.</li><li>Ability to work well with others of diverse backgrounds.</li><li>Knowledge of Global Certifications and Regulatory Standards (UL, IEC, MIL etc.) is an advantage</li><li>Must be capable of multitasking and taking full ownership of assigned projects.</li><li>This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or UK Military controls.</li></ul>

Responsibilities : <ul><li>Product design, including but not limited to, fibre optic connector and termini design, fibre optic cable assembly design, fibre optic flex cable assembly design.&nbsp;</li><li>Support development of fibre optic interconnect systems&nbsp;&nbsp;</li><li>Liaison to Manufacturing plant locations&nbsp;</li><li>Create Engineering Change Requests (ECRs)&nbsp;&nbsp;</li><li>Make changes to drawings in SolidWorks/CREO/ZWCAD to support UK MIL or General Market Controlled ECR/ECNs&nbsp;</li><li>Address requests for product extensions, drawing changes, engineering quotes.&nbsp;</li><li>Handle requests to get part extended and costed SAP&nbsp;&nbsp;</li><li>Support Expanded Bean Product Line for changes and product extensions.&nbsp;</li><li>Create design verification test (DVT)/Qual test plans, create test request&nbsp;&nbsp;</li><li>Support/witness testing in the lab,&nbsp;</li><li>DVT/Qual cable assy design/drawings, component modeling/print creation,&nbsp;</li><li>Participate in DFMEA/PFMEA&nbsp;&nbsp;</li><li>Support design review preparation/presentation&nbsp;&nbsp;</li><li>Model shop requests&nbsp;</li><li>Support build or build prototype parts.&nbsp;&nbsp;</li><li>Working knowledge of manufacturing processes.&nbsp;</li><li>Proficient with MS Office software.</li></ul> Requirements : <ul><li>Fiber optic or rugged fiber optic connector and termini development background</li><li>Degree in appropriate discipline or equivalent work experience with fiber optic connectors, cables, termini, etc&nbsp;</li><li>Fiber optic cable assembly development experience&nbsp;</li><li>Support and lead product development through the product development life cycle&nbsp;</li><li>Experience with Solid works, CREO and Autocad&nbsp;&nbsp;</li><li>Tolerance analysis&nbsp;&nbsp;</li><li>5-8 years design and new product development experience, preferably with electronic or optoelectronic related assemblies, hardware, and components</li></ul>

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

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.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.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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7 dea controlled substances Jobs found

Lead Quality Specialist - Investigator

Manufacturing Engineer - Injection Molding

Test Laboratory Engineer

Fiber Optic Product Development Engineer

Associate I, Quality Operations

Specialist, DEA Compliance

QC Chemist I

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7 dea controlled substances Jobs found

Lead Quality Specialist - Investigator

Manufacturing Engineer - Injection Molding

Test Laboratory Engineer

Fiber Optic Product Development Engineer

Associate I, Quality Operations

Specialist, DEA Compliance

QC Chemist I

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

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