Supervisor, Quality Assurance

Supervisor, Quality Assurance

Position Summary

• Shift: Monday – Friday 8:00am – 4:30pm
• 100% on-site

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Quality Assurance Supervisor will manage the day-to-day activities and employees within their Quality Group. This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). This individual will constantly evaluate the internal processes and procedures and work to create an efficient quality area while maintaining the highest possible quality standards. The Supervisor follows established protocols and work plans. Comply with divisional and site Environmental Health and Safety requirements

The role:

• Oversee daily workflow of QA activities on the packaging and distribution floor, including but not limited to: in-process audits, line clearance, cleaning verification, and labeling approval
• Train and mentor associates as needed
• Resolve problems/issues with internal clients
• Identify continuous improvement opportunities within QA
• Independently lead improvement and/or other projects within QA
• Independently author SOPs and forms
• Effectively utilize problem solving tools (i.e., fishbone, five whys) to lead investigations
• Communicate effectively with both internal and external customers, peers and management to facilitate the smooth and timely completion of projects
• Conduct packaging audits (on-the-floor)
• Identify and report cGMP or SOP compliance issues as necessary

The candidate:

• Bachelor’s degree in physical science preferred; may substitute relevant experience for education.
• Minimum 3 years of experience in a Quality Assurance role in a GxP facility
• Strong knowledge of cGMPs and ability to ensure compliance with SOPs and regulatory requirements
• Experience supporting QA activities on a manufacturing/packaging floor (e.g., audits, line clearance, in-process checks)
• Experience leading or supporting deviations, investigations, and root cause analysis (e.g., fishbone, five whys)
• Ability to work cross-functionally and resolve issues with internal stakeholders
• Strong communication skills with internal and external customers
• Ability to manage multiple priorities and work effectively under pressure to meet deadlines
• Strong organizational skills and ability to handle multiple activities simultaneously

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.

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.

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