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QA Contractor III
311 Pennington-Rocky Hill Road Pennington, NJ 08534 US
Job Description
Job Description:
Perform QC sampling and chemistry testing of raw materials under FDA/EU regulations, applicable International Regulations, company processes and procedures to support GMP manufacturing.
Job Duties:
? Author technical documents including SOPs, Test Methods, Method Verification/Validation Protocols & Reports, Material Specifications.
? Perform compendial (USP/EP) testing of raw materials (starting materials, excipients, primary packaging, manufacturing water) to support manufacturing operations.
? Perform method verification/method validation of raw material test methods.
? Perform QC sampling of raw materials in a cleanroom environment.
? Lead the qualification of QC analytical instruments by authoring and executing IQOQ protocols/reports.
? Lead investigations for OOS results, lab discrepancies, and invalid assays.
? Support QC sample management with the receipt of manufacturing samples.
? Manage receipt and inventory of reagents and supplies for the laboratory.
? Participate in internal and external GMP audits, as needed.
? Undertake any other duties as required.
Core Competencies, Knowledge, and Skill Requirements
Minimum of 5 years with a Bachelor’s or above in Chemistry or related scientific discipline.
? Working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
? Working knowledge and experience with raw material sampling in a cleanroom environment.
? Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, FTIR, Raman spectroscopy, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods.
? Strong working knowledge with USP/EP and cGMP/EU GMP.
? Technical writing experience.
? Familiar with instrument and equipment validation.
? Credible and confident communicator (written and verbal) at all levels.
? Strong analytical and problem-solving ability.
? Hands-on approach, with a ‘can do’ attitude.
? Ability to prioritize, demonstrating good time management skills.
? Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
? Self-motivated, with the ability to work proactively using own initiative.
? Committed to learning and development.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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