QA Release Specialist

BioNTech SE

Specialist QA Release reviewing manufacturing and testing documentation at BioNTech. Ensuring compliance with cGMP regulations and collaborating across quality assurance teams.

Posted 6/24/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesJunior💰 $63,300 - $101,300 per yearWebsite

About the role

Key responsibilities & impact

Perform independent, detailed review of executed batch production (i.e., drug substance, drug product, Linker-Payload, monoclonal antibodies, packaged finished IMP, packaged finished commercial products) and testing records.
Verify compliance with cGMP, approved procedures and regulatory requirements.
Verify compliance with complete product lifecycle supply chain.
Ensure all manufacturing and laboratory activities were performed as approved, documented, contemporaneously, and accurately recorded with appropriate reconciliation of materials, yields, and critical process parameters.
Ensure that all required quality documentation is accurate, approved and archived in accordance with data integrity principles (ALCOA+).
Support batch disposition decisions by confirming all quality events are resolved and closed prior to batch release.
Identify recurring documentation or process issues and escalate trends or compliance risks in accordance with established quality systems.
Participate in continuous improvement initiatives related to batch record review, process, systems, and documentation practices.
Support greater quality assurance team with cross training on operative tasks related to post release operative tasks (i.e. supply and distribution oversight).

Requirements

What you’ll need

Bachelor's degree in scientific or technical discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences, Engineering) or equivalent combination of education and relevant industry experience.
Minimum of 1-3 years’ experience in a regulated pharmaceutical, biotechnology, or life science environment performing activities under cGMP.
Ability to perform independent, detail-oriented reviewed to identify documentation errors, discrepancies, and compliance risks.
Working knowledge of current Good Manufacturing Practice (cGMP) regulations, including FDA requirements applicable to drug substance and/or drug product manufacturing.
Knowledge of data integrity principles (ALOCA+) and expectations for contemporaneous, accurate, and complete documentation.
Proficiency in electronic quality systems and document management systems (i.e., QMS, LIMS, SAP).
Experience working cross functionally across many different departments to resolve quality and documentation issues.
Strong written and verbal communication skills, with the ability to clearly document rationale and communicate quality concerns.
Ability to work in a fast-paced, regulated environment while meeting timelines and maintaining compliance.

Benefits

Comp & perks

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more!

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

batch production reviewcGMP compliancequality documentationdata integrity principlesdocumentation error identificationquality event resolutioncontinuous improvementprocess documentationregulatory requirementsdrug substance manufacturing

Soft Skills

detail-orientedindependent reviewcross-functional collaborationstrong communication skillsproblem-solvingtime managementcompliance awarenesstrend identificationescalation of compliance riskstraining and support