Quality Assurance Specialist II — Biopharma Contract

ACTalent; Plainville (MA); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Plan Pre-tax & Roth

Life Insurance

Disability (short/long-term)

HSA

Job summary

Actalent is seeking a Quality Assurance professional to review batch records, assess product disposition, and ensure release readiness for biopharmaceutical programs. The role requires an advanced degree or a bachelor’s with experience in a regulated environment, with strong cGMP knowledge and cross-functional collaboration.

You will evaluate manufacturing data, support CAPA and change controls, and communicate decisions clearly to Manufacturing, Regulatory Affairs, and QC teams.

Qualifications

• Advanced degree plus 2 years of experience or Bachelor's plus 3 years in Quality Assurance/Quality Control within a regulated biopharmaceutical or biotechnology environment.
• Preferred fields include Life Sciences, Biology, Microbiology, Biochemistry, Chemistry, or Engineering.
• Strong knowledge of cGMP, regulatory expectations, and industry guidance for biologics/pharmaceutical manufacturing.
• Experience with batch record review/approval, product disposition, and manufacturing documentation for commercial and clinical products.
• Familiarity with deviation investigations, CAPA, change control, and risk assessment methodologies.
• Ability to evaluate product impact and make disposition decisions using manufacturing, testing, validation, and quality system data.
• Experience reviewing analytical testing results, environmental/process data, validation reports, and quality documentation to support release decisions.
• Knowledge of manufacturing processes, aseptic operations, upstream/downstream processing, and/or fill-finish operations preferred.
• Experience with TrackWise, Veeva, SAP, LIMS, document management, and electronic batch record platforms.
• Strong technical writing and documentation review skills; ability to document quality decisions clearly.
• Excellent attention to detail; identify discrepancies and compliance risks.
• Strong problem-solving, critical-thinking, and risk-based decision-making skills.
• Ability to communicate quality requirements and disposition decisions to cross-functional stakeholders (Manufacturing, MSAT, QC, Supply Chain, Validation, Regulatory Affairs).
• Strong organizational skills to manage multiple disposition activities in a fast-paced environment.
• Ability to work independently with sound judgment within quality systems.
• Working knowledge of statistics, trending tools, and quality metrics.
• Experience supporting regulatory inspections and customer audits.
• Demonstrated GMP disposition decisions, including evaluation of batch record exceptions, deviations, change controls, lab results, and release documentation.

Responsibilities

• Review and approve batch records and disposition decisions for commercial and clinical products.
• Evaluate manufacturing documentation, testing data, and validation reports to support release.
• Manage deviation investigations, CAPAs, change controls, and risk assessments.
• Communicate quality requirements and disposition decisions to cross-functional partners.
• Ensure documentation is accurate, complete, and in compliance with regulatory standards.
• Support regulatory inspections and customer audits as needed.

Job description

Actalent is seeking a Quality Assurance professional to review batch records, assess product disposition, and ensure release readiness for biopharmaceutical programs. The role requires an advanced degree or a bachelor’s with experience in a regulated environment, with strong cGMP knowledge and cross-functional collaboration.

You will evaluate manufacturing data, support CAPA and change controls, and communicate decisions clearly to Manufacturing, Regulatory Affairs, and QC teams.