Batch Record Reviewer II

Catalent • MD

324d • $93,280 - $128,260

About The Position

We're hiring a Batch Record Reviewer II to provide documentation support for all pharmaceutical manufacturing activities in Baltimore, Maryland. Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Batch Record Reviewer II is responsible for providing support to GMP documentation of master/working cell banks, bulk drug substance, and finished drug product. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements. This is a full-time, salaried position and is 100% site based. The schedule is Monday - Friday, 1st shift. Catalent’s FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus in Baltimore, Maryland. The campus, featuring two manufacturing facilities, supports Phase 3 through commercial manufacturing of advanced therapeutic products, including Adeno-associated Virus (AAV), and other viral vector-based therapies and vaccines. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Requirements

• Bachelor’s degree with a minimum of 4 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field.)
• Demonstrated success in the documentation of GMP processes.
• Minimum of 2 years of experience in a Quality Assurance/Quality Control or Manufacturing function.
• Prior experience with the documentation of GMP processes.
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines.

Responsibilities

• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents.
• Independently executes batch record review for completeness, accuracy and cGMP compliance.
• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.
• Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs.
• Compile and report performance metrics for Batch Review and Release.
• Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Other duties, as assigned.

Benefits

• Medical, dental, vision, and wellness benefits are effective on the first day of employment.
• Potential for career growth on an expanding team and organization.
• 152 hours of paid time off annually plus 8 paid holidays.
• Community engagement and green initiatives.
• Engaging D&I Employee Resource Groups.
• Tuition reimbursement program.
• Generous 401K match.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree