QA Release

Sanofi • Swiftwater, PA

5d • Onsite

About The Position

As a QA Batch Review Specialist on the Quality Assurance team at the Swiftwater site, you will support product quality by reviewing and releasing batches for market. The role works flexibly to meet compliance requirements and manufacturing and release schedules. It encompasses batch-record review and disposition for Swiftwater and contract manufacturing organizations (CMOs), lot-release protocol review, preparation and certification of working documents, environmental monitoring summaries, and compliance and performance activities.

The position reviews manufacturing documentation and testing, verifies that batches meet applicable GMP, regulatory, and product requirements, and completes associated system transactions. It also prepares and reviews lot-release protocols and batch records, supports environmental monitoring summary timelines, contributes to focus factory initiatives and team projects, and helps improve quality and process efficiency. The role may act as a trainer, investigate assigned deviations, and perform other tasks as assigned.

The work environment is described as a highly collaborative and technical vaccine manufacturing operation on a park-like campus. The position is based in Swiftwater, Pennsylvania. The salary range is $69,000.00–$99,666.66, with compensation determined based on demonstrated experience.

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 batch-release issues or deviations efficiently.
• Ability to manage multiple projects 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 other applicable health-authority regulations.
• Complete required system transactions for 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 confirm required testing was performed and meets requirements before batch disposition.
• Before disposition, verify applicable CBER release, confirm the lot is not on hold, and ensure previous manufacturing steps, including raw materials, are satisfactory.
• Complete required system transactions for batch disposition and, when assigned, act as delegate to the QA Release Lead to approve shipments to external manufacturers.
• Prepare and review working lot-release protocols for completeness and accuracy before submission to the applicable health authority.
• For licensed international products, ensure batches comply with GMP requirements and the importing country's Marketing Authorization specifications.
• Meet lot-release protocol review cycle-time requirements and confirm completion in SAP.
• Oversee the Environmental Monitoring Summary process to meet timelines and compliance standards; compile and review data, finalize reports in the electronic database, and meet release timelines for assigned lots.
• Serve as a subject-matter expert and liaison for assigned focus factory initiatives, participate on teams, communicate issues, and identify solutions that support release timelines.
• Contribute to team objectives and assigned projects.
• Prepare batch records from master documents in the electronic document management system and certify prepared records for completeness and accuracy according to procedure.
• Support right-first-time preparation and completion of documentation in SAP and/or FaCT, and help ensure records are prepared and certified to the production planning schedule.
• Provide metrics for +QDCI board meetings.
• Meet departmental safety, quality, productivity, and cost targets in a compliant and timely manner.
• Act as a trainer for batch-release activities and investigate assigned deviations.
• Perform special projects assigned by the FFIP QA Leadership team; review PQBR processes and recommend, develop, 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 batch records that meet requirements; ensure deviations are opened and reported when practices do not meet quality requirements; review batch-disposition documentation; and advise on quality-culture initiatives and topic presentation.

Benefits

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

What This Job Offers

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