**Onsite Role in Lexington, KY**
Job opportunity with a top Pharmaceutical company that is looking for a QA Specialist to join their team on a 6-month contract, likely renewal for another 6-12 months at the end, possibly permanently hire,
Qualifications:
- Bachelor's degree (B.A/B.S.) from four-year college or university
- 2-3 years' experience in the pharmaceutical industry.
Job Description/Skills:
- Review QA documentation including Event/Deviations Records, Batch records, protocols, stability reports, laboratory reports
- Perform data verification activities and potentially internal audits
- Review ANDAs, supplements, and amendments and highlight any major gaps in the submission documents
- Creation and Maintenance of Drug product labeling including track of RLD labeling updates creation and drug listing activities.
- Preparation and submission of Labeling Supplements, Annual Reports, and other administrative FDA correspondences.
- Independently review, compile, and submit high-quality controlled correspondences and meeting requests
- Initiated, evaluated and approves change controls (as needed) in accordance with FDA and ICH guidelines
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
