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.

Catalent Cell & Gene Therapy is looking to recruit a Senior Quality Assurance Specialist, On the Floor Support (OTF) to join our growing BWI team in Harmans, MD.

The Senior Quality Assurance Specialist, OTF provides 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 oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Executing assigned quality tasks (including pre-approving instructions, reviewing documentation of executed instructions, reporting metrics, document drafting, report writing), providing review and approval of change requests (e.g., Trackwise change controls and EDMS document change requests), approving item masters, product specifications and materials for usage in manufacturing, providing direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments, and reviewing resolution and effectiveness of corrective actions and audit responses.

This is a full-time position: 3rd Shift Tue-Fri 10PM-8:30AM. This role represents two openings and will remain open until both positions are filled.

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.

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.

The Role:

• 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.
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Review and approve batch documents for media and buffer prep solutions; Generate or revise 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; 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 – 70% of day is spent on the floor.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.
• Provides QA support and escorting of Client Person in Plant (PIPs), if required; Act as QA reviewer for events/deviations and CAPA issuance; Make solid quality decisions with limited oversight.
• Identify and implement and continuous improvement initiatives and participate in site and corporate quality and process improvement initiatives.
• Represent QA on project teams and represent QA perspective as necessary and guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices. Partner with Manufacturing and other support teams.
• Other duties as assigned.

The Candidate

• Bachelor’s degree required; STEM preferred.
• Master’s degree preferred.
• 5+ years’ experience within the biologic, biopharmaceutical, or regulated industry; 3+ years’ experience in Manufacturing/Quality Assurance/Quality Control function preferred.
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; Experience or knowledge in Trackwise preferred.
• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish; Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Creative individual with excellent trouble shooting and decision-making skills; Ability to quickly learn new and novel manufacturing processes supporting new clients who is able to work in a team setting and independently under minimum supervision; Requires the ability to produce results in a fast-paced environment to meet client deadlines with strong technical and quality background.
• Able to effectively interpret new and existing global regulations and to communicate effectively with all levels of personnel and regulatory inspectors; Clear problem-solving and decision-making skills with the ability to function well in a changing environment.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• 19 days of PTO + 8 paid holidays
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.