Specialist, Quality Assurance Operations

Catalent Pharma Solutions Madison, WI


Job Description

Specialist, Quality Assurance Operations


Position Summary


Catalent is looking to recruit a Specialist, Quality Assurance Operations to join a growing Quality team in Madison, WI.


The Specialist, Quality Assurance Operations assures that all operations at Catalent meet or exceed cGMP regulations and client customer requirements. The Specialist, Quality Assurance Operations assures the quality of Cell Banks and Bulk Drug Substance produced and supports release of BDS for further clinical manufacturing of drug product. This position also ensures quality of manufacturing and laboratory data and reports. This is accomplished by direct collaboration and oversight of Manufacturing Operations and Quality Control and the review/audit of data and reports as specified by Standard Operating Procedures.


In concert with Catalent’s Patient First philosophy, this role safeguards all systems, processes and actions to ensure regulatory compliance is met, which is essential in the manufacture of quality products. These products are delivered for use in our customer’s clinical studies, which promote future marketed medicines.


The Role

  • Reviews QC testing records, environmental monitoring data, and all supporting records.
  • Reviews and approves ancillary facility and equipment records in support of GMP operations.
  • Reviews and approves assay qualification, equipment, and stability protocols.
  • Maintains and enhances effectiveness of the Quality System.
  • Identifies and drives resolution of all documentation issues to allow for timely release.
  • Provides technical assistance and training for personnel.

The Candidate

  • Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 4years’ related experience; or
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 7 years’ related experience.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Potential for career growth within an expanding Quality team
  • Defined career path and annual performance review & feedback process
  • Cross functional exposure to other areas of Quality
  • Medical, Dental, Vision, and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays


About Catalent


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. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to explore career opportunities.


Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to [Click Here to Email Your Resumé]. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.