Pharmaceutical Quality Assurance Specialist
2 weeks ago
Scientist, Quality Control, Pharmaceuticals
GForce Life Sciences is seeking a skilled Scientist to join our team as a Quality Control Specialist in the pharmaceutical industry. As a key member of our team, you will be responsible for ensuring the accuracy and compliance of developmental, clinical, and commercial pharmaceutical products.
Key Responsibilities
- Review and analyze analytical data, including raw data, for accuracy and compliance with client and GxP requirements.
- Initiate and monitor stability studies of developmental, clinical, and commercial pharmaceutical products tested by contract laboratories.
- Enter and maintain stability data for developmental, clinical, and commercial pharmaceutical products.
- Create studies in LIMS for multiple projects and enter or review sample test result data.
- Assist in technical investigations and enter deviations and investigations into Trackwise.
- Maintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with GDP and data integrity standards.
- Prepare stability reports and summaries for inclusion in regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
Requirements
- Bachelor's degree in chemistry or related science + 5 years' work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials.
- Familiarity with GMP environment focused on analytical laboratory testing, including HPLC, Dissolution, etc.
- Experience with MS Office, especially MS Excel, and data review.
Nice to Have
- Experience with electronic document management systems – Veeva, CARA, etc.
- Experience with investigation software (Trackwise preferred) and laboratory information management systems (LIMS).
Contract Details
- 12-month contract, open to 12+ month extension.
- 2 Video Interviews – Start 2 weeks from an offer.
- Full-time, 40 hours/week (EST hours).
- Remote with onsite expectations a few times per year in Maryland.
- Benefits included (Medical, Dental, Vision, 401k).
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