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Quality Assurance Associate - Data Review

About Catalent San Diego

Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing.

At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

Quality Assurance Associate, Data Review Summary

Quality Assurance Associates are responsible for supporting quality systems to advance the development and manufacture of drug candidates, including data and document review and approval, support of GMP manufacturing, and assistance with internal and external auditing.

Responsibilities include, but are not limited to the following:

  • Review and approve release and stability data, certificates of analysis, development and validation reports, analytical testing protocols, and stability chamber validations
  • Maintain Quality Assurance logbooks for document change control, instrument calibration schedule, stability pull schedule, test method and technical reports, and certificates of analysis
  • Perform internal audits of the analytical laboratories and Quality Assurance systems as well as in-phase audits of GLP studies
  • Support GMP manufacturing activities including release of GMP materials, performance of line clearances in a Class 100,000 environment, maintenance of clinical trial material inventory logs
  • Supportive role in hosting client and regulatory audits

Requirements

  • Candidate will have a BS/BA science degree (Chemistry or Biochemistry preferred).
  • Candidate will have 1 to 2 years of analytical chemistry/HPLC experience (candidates without this experience WILL NOT BE CONSIDERED).
  • Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude. This position requires a high level of interaction with multiple departments, as well as clients.

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

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

 

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