Pharmaceutical Quality Assurance Specialist

Proclinical is seeking Pharmaceutical Quality Assurance Specialist for a leading CDMO located in Springfield, MO.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• The Quality representative is responsible for the collection of information from any commercial API, commercial Intermediates of APIs for the report template and help on the preparation of the report.
• Data to collect manufactured batches from previous period, from executed Batch Records, (In-process Control Results), Critical Process parameters, Significant quality control parameters, yield.
• Information to be collected from Trackwise (CAPAs, Deviations, Change Controls and Customer Complaints).
• Other documentations to be collected, Returns, Recalls or Rejection. Review of reprocessed and reworked batches from the APR period.
• Approved Starting Material vendors and manufacturers, GMP intermediates, packaging components, contract manufactures and contract laboratories.
• Visual inspection of retain samples also are required during the Intermediate or API period.

Skills and Requirements:

• Bachelor's degree in Chemistry, Natural Science or Pharmacy or equivalent required with 3+ years of previous professional experience.
• Experienced in the application of GMP principles.
• Minimum of 2 years in an FDA or other equivalent regulated industry.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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