Specialist QA Release
Cambridge, US | full time | Job ID: 11193
About the role:
The specialist role within QA Release is responsible for timely and compliant review of manufacturing and testing documentation to support the release of investigational and commercial drug products. As a part of the batch record review and release team, operative tasks are performed following cGMP, internal procedures and applicable regulatory requirements. This role ensures that executed batch records, associated deviations, investigations, and supporting quality documentation are complete, accurate and approved prior to disposition decisions. The specialist works cross functionally with other quality assurance teams, quality control, supply chain, distribution and more. This position plays a critical role in ensuring product quality, patient safety, and uninterrupted supply.
Your contribution:
• 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)
A good match:
• 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.
Preferred Qualifications:
• Prior experience in supporting release of clinical and/or commercial material.
• Familiarity with ICH guidelines (Q7, Q9, Q10) and 21 CFR 211.
Expected Pay Range: $63,300 - $103,300/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Your Benefits:
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- 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! More details to be shared.
Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Apply now - We look forward to your application!
Apply for our Cambridge, US location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.