Senior Associate, Quality Assurance Operations

Location
Madison, Wisconsin
Posted
Apr 09, 2018
Ref
0026008
Required Education
Bachelors Degree
Position Type
Full time

The Senior Associate, Quality Assurance Operations serves as ‘Quality on the Floor’ to assist and support manufacturing staff in detecting and solving compliance errors in real time. In this role, the Senior Associate, Quality Assurance Operations will audit GMP areas including during production and maintains effectiveness of the Quality System.

The Role

  • Reviews batch records and all supporting records.
  • Issues manufacturing batch records and labels.
  • Reviews ancillary facility and equipment records in support of GMP operations.
  • Compiles complete batch records through collection of documentation from multiple sources (production, labs, etc.).
  • Identifies and drives resolution of all documentation and batch record issues to allow for timely release.
  • Assures Bulk Drug Substance is manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
  • Provides technical assistance and training for personnel.

The Candidate

  • Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; or
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 3 years’ related experience; or
  • Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 4 years’ related experience.

Position Benefits

  • Competitive base salary with other compensation incentives
  • Medical, Dental, Vision, and 401k are all offered on day one of employment
  • 19 days of Paid Time Off (PTO) + 7 paid holidays
  • Defined career path and annual performance review and feedback process

About Catalent

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to explore career opportunities, or contact us at   

+1 877 503 9493.

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, or protected veteran status. 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 Jobs@catalent.com. 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.