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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GMP Quality Systems, batch record review, and product disposition within the pharmaceutical industry, ensuring compliance with cGMPs and regulatory standards. Strong analytical and organizational skills facilitate effective communication and collaboration across cross-functional teams.
Highest-signal resume keywords
GMP Quality Assurance ExperienceBatch Record ReviewQuality Systems KnowledgeDeviation and CAPA ManagementRegulatory Inspection Preparation
About the role
Key responsibilities & impact- Support quality oversight of vendors to ensure drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with cGMPs
- Lead batch record review and clinical lot disposition for drug substance, inhaled drug product, and clinical packaging and labeling
- Support QP certification and release activities at contract manufacturing partners for ex-US clinical trials
- Prepare batch documentation packages and coordinate release timelines with CMOs, Supply Chain, and Clinical Operations
- Review executed batch records, certificates of analysis, and testing data for accuracy, completeness, and conformance
- Drive resolution of documentation errors and gaps
- Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations
- Maintain disposition and batch review tracking and metrics
- Communicate product quality performance and release status to Quality and cross-functional teams
- Partner with CMC, Supply Chain, and Regulatory Affairs on product quality impacts, risks, and mitigation plans
- Review and provide quality input on batch records, specifications, test methods, protocols, reports, and SOPs
- Support batch release and disposition procedures
- Support regulatory inspection preparation and inspection readiness activities
Requirements
What you’ll need- BA/BS degree in Chemistry, Biology, or Life Sciences
- At least 4 years of experience in the pharmaceutical industry, including GMP quality assurance experience
- Demonstrated knowledge of Quality Systems and cGMP within a regulated environment
- Hands-on experience with batch record review and product disposition/release for clinical or commercial pharmaceutical products
- Working knowledge of Good Distribution Practices and ex-US clinical supply requirements, including EU Annex 13 and QP release preferred
- Experience with deviation, investigation, CAPA, change control, and OOS/OOT processes at CMOs
- Familiarity with inhaled drug product, drug substance, and/or clinical packaging and labeling operations preferred
- Auditing experience preferred
- Strong attention to detail and analytical skills, with ability to apply risk-based decision making
- Strong interpersonal skills and ability to influence and build rapport across functions and with external partners
- Excellent organizational and time management skills; ability to manage multiple concurrent batches and tight release timelines
- Excellent verbal and written communication skills
- Experience in fast-paced, start-up environments preferred
- Ability to work under pressure amid changing priorities and tight deadlines
Benefits
Comp & perks- Equal employment opportunities and nondiscrimination protections
- No unsolicited resumes or agency outreach accepted
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CGMP ComplianceBatch Documentation PreparationClinical Lot DispositionGood Distribution PracticesOOS/OOT InvestigationAnalytical SkillsRisk-Based Decision MakingQuality Input on SOPsClinical Packaging OperationsAuditing Experience
Soft Skills
Attention to DetailInterpersonal SkillsOrganizational SkillsTime ManagementCommunication Skills
Industry Keywords
Pharmaceutical IndustryDrug SubstanceInhaled Drug ProductClinical TrialsEx-US Clinical SupplyEU Annex 13Change ControlClinical OperationsSupply ChainQuality Performance