The Sr. QA Specialist - Microbiology Contamination
is responsible for providing Quality Assurance oversight of Catalent's GMP Manufacturing Facilities, Critical Utility Systems, and associated programs to ensure compliance with applicable regulatory and industry standards, guidance's, and Catalent policies/procedures related to contamination control. The position will provide continuous improvement support specific to contamination control initiatives and will serve as the key QA resource for the Quality Control Microbiology organization. Responsibilities include QA Review and Approval of Environmental Monitoring and Critical Utility Trend Reports and other GMP documentation, QA Review and Approval of contamination control related deviations, including HVAC shutdown, EM/CU Investigations, and CAPA in TrackWise, and On-The Floor oversight of Manufacturing including observation of aseptic technique during critical processes, gowning practices, and equipment/material transfer and storage practices.
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of 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. Interested in learning more about life at Catalent?The Role:
- Review and approve quarterly and annual Environmental Monitoring and Critical Utility Trend Reports; Represent QA in the monthly Environmental Monitoring Review Board (EMRB), providing guidance and feedback where required
- Partner with the QA On-The-Floor team to perform monthly QA Walkthroughs of Catalent's GMP Manufacturing facilities and provide feedback and coaching related to contamination control best practices; Perform QA On-The-Floor activities supporting client projects, including observation of critical processes and aseptic technique, gowning practices, transfer and storage of materials and equipment, and resolution of issues that occur during manufacturing
- Provide QA support for deviations related to contamination control, including HVAC disruptions and Environmental Monitoring and Critical Utility excursion investigations. Participate in Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA)
- Support the Risk Management Program to evaluate and mitigate contamination risks associated with utilities and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools
- Serve as a QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to utilities and facilities; Serve as a QA resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI) and EMPQ of cleanrooms
- Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices
- Perform creation/revision and review/approval of GMP documentation such as Standard Operating Procedures (SOPs) and protocols
- Serve as the QA liaison with the QC Microbiology, Manufacturing, Facilities, and Engineering organizations to support company goals, client projects, continuous improvement initiatives and as a general resource; Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and provide QA perspective as necessary; Support client and regulatory audits
- Other duties as assigned
- B.S. in a Life Sciences discipline and 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
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish
- Creative individual with excellent trouble shooting and decision-making skills; Ability to function in a changing environment with new manufacturing processes supporting new clients; Able to work in a team setting and independently under minimum supervision; Strong attention to detail and strong organizational skills; Strong verbal communication skills with the ability to communicate effectively with all levels of personnel and regulatory inspectors; Strong technical and quality background
Catalent offers rewarding opportunities to further your career!
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross functional exposure to other areas of within the organization
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 8 paid holidays
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.
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