PCI Pharma Services · 2 days ago

QA Associate II - Operations

Bedford, NH

Full-time

Onsite

Entry, Mid Level

2+ years exp

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BiotechnologyHealth Care

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Responsibilities

Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real-time, and resolving issues that occur during manufacturing

Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices

Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy, and compliance

Support the evaluation and lot disposition of intermediates, finish bulk drug substance, and drug product

Act as first responder for on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions

May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.

Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management

Perform Acceptable Quality Limit (AQL) visual inspection of drug product

Participate in SOP revision as it pertains to process improvements

Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary

Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices

Qualification

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RCATechnical WritingQuality InvestigationsFDA RegulationsInternational RegulationsRisk Management ToolsFMEAHACCPPHAICH Q9ASQ Certification

Required

Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 2-3 years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production

Exposure to RCA, technical writing, and working with quality related investigations

Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH

Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred