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Quality Assurance Specialist - 2nd Shift Full-time

at Catalent Pharma Solutions in Pennsylvania (Published at 13-07-2018)

Quality Assurance Specialist - 2nd Shift


Position Summary


The Quality Specialist reports to the Director, Quality Assurance.


The Quality Assurance Specialist ensures all the products and services offered by Catalent are of the highest

quality in terms of satisfaction, predictability, and sustainability.


Catalent Micron Technologies Malvern facility specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry. It is equipped with advanced systems to handle highly potent and cytotoxic compounds, and provide leading analytical services associated with particle size engineering and material characterization testing from early stage development to commercialization.


The Role

  • Batch Manufacturing Record Review/Approval and Release and Laboratory Reports Review and Approval
  • Maintaining QA Databases and management of Document Control System (Trackwise)
  • Development, Review, Approval of Relevant Quality System Policies and Procedures
  • Assisting, reviewing and writing investigation(s)
  • Issuing and Reconciling Deviation, Variation, OOS Forms
  • Management of Batch Manufacturing Record Issuance and Reconciliation
  • Preparing for, performing and overseeing Client Audits

The Candidate

  • B.S. / B. A. or 2 or more years experience
  • 5 or more years experience in the pharmaceutical industry including a working knowledge of GMPs
  • Training/Auditing
  • Trackwise Experience a plus but not required

Position Benefits

  • 2nd Shift Hours are VERY Flexible
  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays

Leadership Competencies for Performance and Development

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

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 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.



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