• 
  Provide appropriate SOP, Work Instruction and cGMP training for the release team and other personnel, as needed.
• Establish a ‘compliance first’ environment and expectation within the release team. Monitor the team’s performance and assure that proper finished product disposition determinations are made.
• Provide appropriate supervisory leadership to subordinate team members.
• Coordinate release team activities with other PAI departments.
• Review analytical documentation of lab testing per specifications and USP methodology to assure finished goods are acceptable for distribution.
• Review batch records including but not limited to manufacturing batch records, packaging records, QA data, investigations, protocols, and other associated documentation to assure they are compliant with SOPs, Work Instructions, and cGMPs.
• Disposition finished product in accordance with SOPs and Work Instructions.
• Maintain accurate and timely spreadsheets, logs, reports, and inventory records.
• Collect and report metrics and drive the achievement of goals pertinent to the position.
• Assist others, as needed, with information or reviews to support investigations.
• Maintain secure control of all records for which the team is responsible.
• Perform other Quality Assurance duties as required.

• 
  At least three years’ progressive experience in pharmaceutical quality assurance.
• Four year college degree in an applicable field or equivalent mix of education and experience.
• General science background with knowledge of lab instrumentation and testing including familiarity of FDA and USP testing requirements.
• Sound understanding of cGMPs and record documentation requirements.
• Proficient in the use of MS Office.
• Strong technical writing skills, in English.
• Strong critical thinking ability and math skills.
• Self-starting time manager.
• Team-building, positive interpersonal skills.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EOE, including disability/vets

PAI uses e-verify