$24-$28 per hour direct hire
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in GMP’s and FDA Guidance Documents. The requirements listed below are representative of the knowledge, skills and/or abilities required.
• High School diploma/GED required
• 2+ years of manufacturing or pharmaceutical experience preferred
• Good knowledge of FDA cGMP's
• Detail oriented and strong organizational skills
• Writing and basic computer skills (Microsoft Word and Excel)
• Ability to interact with many departments
Review all Batch Record documentation and protocol procedures documentation to ensure they are being followed accurately by employees.
Issue labeling materials to manufacturing and ensure correctness and completeness of work performed.
Verify that all manufacturing areas in operation are following current Good Manufacturing Practices (GMP’s) and specific standard operating procedures (SOP).
Perform internal daily and routine audits of all systems within the operation. Document the results of audits performed and inform management of noncompliant issues.
Working knowledge of GMP’s and FDA Guidance Documents is essential to this function as well as proven ability to be detail oriented.