Quality Assurance Specialist
5 days ago
We are seeking a highly skilled Quality Assurance Specialist to support our QA Lead and quality program by auditing analytical data, routine work, protocols, and reports.
Key Responsibilities- Review and release analytical data for conformance to regulatory, company, and customer requirements.
- Alternate contact person for QA questions relating to laboratory operations and client correspondences.
- Review laboratory protocols and reports for accuracy and compliance to cGMP's, as applicable.
- Verify data for GMP material (raw material, in-process, finished product, packaging, labeling, and manufacturing components) was reviewed and approved by appropriate SMEs.
- Review and approval of documents and data associated with the Stability Program.
- Perform other assigned responsibilities as established by the Quality Assurance Lead.
Qualifications include a Bachelor's degree in a related science discipline with 0-3 years of QA experience, preferably in a pharmaceutical industry.
Minimum skills requirements include knowledge of GMPs related compliance regulations and guidances, excellent organizational, analytical, verbal communication, and technical documentation skills, good computer skills, and the ability to work effectively in a team environment.
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