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Senior Specialist, QA OTF - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/21/2024
Sr. Specialist, QA OTF - Night ShiftPosition SummaryCatalent 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.--Catalent's Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.The Sr. Specialist, QA-OTF is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA On-The-Floor (OTF) oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. --This position is Night Shift 7PM-7AM 2-2-3 schedule and is 100% on site at BWI/Harmans, MD facility.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.This posting represents 4 open positions and will remain posted until all positions are filled.The Role: - Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product - 80% of day is spent on the floor.
- Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing; partners with Manufacturing and other support teams
- Performs Acceptable Quality Limit (AQL) visual inspection of drug product; reviews and approves batch documents for media and buffer prep solutions; generates or revises GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's; compile deviations as required when observed on the floor, and move to completion within the required time frame
- Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
- Identifies and implements continuous improvement initiatives; participate in site and corporate quality and process improvement initiatives; makes solid quality decisions with limited oversight
- Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
- Actively participates in training activities, managing their individual training plan.
- Other duties as assigned.The Candidate:
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