QA Release

Sanofi • Pocono Township, PA

6d • $69,000 - $99,667

About The Position

The QA Release role, described as a QA Batch Review Specialist within the Quality Assurance team, supports product quality and release to market for the Swiftwater site. The position performs batch review and disposition activities for Swiftwater and contract manufacturing organizations (CMOs), and helps ensure compliance requirements and manufacturing and release schedules are met.

The role includes reviewing manufacturing records and lot release documentation, preparing and certifying working batch records, overseeing environmental monitoring summaries, and supporting compliance and performance objectives. It also contributes to team projects, serves as a trainer for batch release activities, investigates assigned deviations, and recommends process improvements. The position operates in a collaborative, technical vaccine manufacturing environment on a park-like campus.

Requirements

• Bachelor’s degree.
• At least 1 year of experience in a GMP-controlled pharmaceutical environment, such as Quality Assurance, Production, Quality Control, or a related area.
• Ability to meticulously review batch records and documentation for accuracy and regulatory compliance.
• Ability to investigate and resolve issues or deviations related to batch release processes.
• Ability to manage multiple projects simultaneously and complete them on time while meeting quality standards.
• Strong computer literacy, including Microsoft Excel, PowerPoint, and Word.
• Ability to analyze complex data and identify trends, issues, and solutions.
• High accuracy and attention to detail in quality assurance activities.
• Ability to identify problems and implement effective corrective actions.
• Strong verbal and written communication skills for interacting with team members and regulatory bodies.
• High level of autonomy.

Responsibilities

• Perform final quality review of completed manufacturing records for completeness and accuracy in accordance with site procedures, cGMP, FDA 21 CFR, and applicable health authority regulations.
• Complete system transactions associated with batch record review and provide manufacturing-date and commodity-verification information for further material processing.
• Review specification checklists and certificates of analysis or conformance to verify required testing is complete and meets requirements before batch disposition.
• Verify required CBER release, absence of holds, and satisfactory completion of previous manufacturing steps, including raw materials, before batch disposition.
• Complete system transactions associated with batch disposition and, when assigned, act as delegate to the QA Release Lead to approve shipment to external manufacturers.
• Prepare and review working Lot Release Protocols for accuracy and completeness before submission to health authorities.
• Ensure licensed international products meet GMP requirements and the importing country’s Marketing Authorization specifications.
• Meet Lot Release Protocol review cycle times and confirm completion in SAP.
• Oversee environmental monitoring summary processes to meet timelines and compliance standards; compile and review data, finalize reports in the electronic ESUM database, and meet release timelines.
• Serve as a subject-matter expert and liaison for assigned focus factory initiatives, participate on teams, communicate issues, and identify solutions supporting release timelines.
• Contribute to team objectives, priorities, and assigned projects.
• Prepare batch records from master documents in the electronic document management system and ensure accurate, right-first-time documentation using SAP and/or FaCT.
• Support preparation and certification of records according to the production planning schedule and certify prepared batch records for completeness and accuracy.
• Provide metrics for +QDCI board meetings.
• Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner.
• Act as a trainer for batch release activities.
• Investigate assigned deviations, perform special projects assigned by FFIP QA leadership, and review PQBR processes to recommend and implement efficiency and quality improvements.
• Review and approve CAPAs as required and complete additional tasks assigned by the Team Lead.
• Prioritize quality and compliance objectives; approve a batch record when it is correctly completed and meets quality requirements; identify practices that do not meet requirements and ensure deviations are opened and documented.
• Review batch disposition documentation and advise on quality-culture initiatives and presentation of topics.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee benefit programs; further information is available through the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level