QA Release

Job Title: QA Release

Location: Swiftwater, PA

About the job: 

Your job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.

This role provides quality oversight of the batch release process.  This role will perform final batch release and lot disposition for product distributed from the Sanofi Swiftwater Site and release from relevant Commercial Manufacturing Organizations (CMOs)

Benefits of working in this role: 

Be part of an inspiring mission to create life-saving vaccines

Leading a skilled and motivated team of quality professionals

The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

Join a global network that powers how Sanofi delivers, seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities

Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

Reviewing batch records and associated documentation

Fostering a culture of quality and continuous improvement across the organization

Participating in internal and external audits and regulatory inspections providing support and documentation

Conducting risk assessments and implementing mitigation strategies for batch release processes

Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities

Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)

Collaborating with regulatory affairs to ensure compliance with local and international regulations

Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness

Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots

Perform and lead Environmental Data Summary Review, Lot Release Protocol generation/approval, and CMO release as applicable.

Any other tasks as assigned by team Lead

Disposition of Batches 

Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.

Verify CBER release is received (if applicable) prior to batch disposition.

Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.

Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.

Complete all required system transactions associated with the batch disposition process.

Act as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned

Key Involvement in Decision Making: 

Prioritize quality and compliance objectives (D)

Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

Review and approve documentation for batch disposition (A)

Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages

Advise on initiatives to promote a quality-focused culture (A)

Advise on how to present a topic and answer specific questions (A)

About You

Basic Qualifications

Bachelor's degree.

3+ years of experience in Quality Assurance within the pharmaceutical industry.

Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Technical Skills

Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.

Capability to investigate and resolve issues or deviations related to batch release processes efficiently.

Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.

Strong Computer Literacy (including Microsoft excel, power point, word)

Soft Skills:

Ability to analyze complex data and identify trends, issues, and solutions

High level of accuracy and attention to detail in all quality assurance activities

Proficiency in identifying problems and implementing effective corrective actions

Strong verbal and written communication skills for effective interaction with team members and regulatory bodies

High level of autonomy

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$78.000,00 - $112.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can  be found here.