Lead Specialist, Qa Batch Disposition

$5,000 Sign-On Bonus

Catalent Cell & Gene Therapy is looking to recruit a Lead Specialist-QA Batch Disposition to join our growing BWI team in Harmans, MD. The Lead Specialist-QA Batch Disposition is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed.

This is a full-time position: Tuesday-Friday; 12PM-10:30PM

Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The Role:

• Independently executes batch record review for completeness, accuracy and cGMP compliance.
• Ability to quickly process complex information and make critical decisions with limited information required.
• Other duties as assigned.
• Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
• 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.
• Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met.
• Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.
• 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.
• Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate.

The Candidate

• Individual may be required to sit, stand and walk regularly.
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines.
• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish preferred.
• Bachelors’ degree in a Scientific or Life Science discipline with 6 - 8 years’ experience OR Masters’ degree in a Scientific or Life Science discipline with 4 - 6 years’ biologic, biopharmaceutical, or regulated industry.
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Medical, dental and vision benefits effective day one of employment
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
• Generous 401K match
• Tuition Reimbursement
• Employee Stock Purchase Program
• GymPass program to promote overall physical wellness
• 19 days of PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

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