PERFORMS ONE OR MORE OF THE FOLLOWING QA SPECIALTIES:  

• Performs and/or assists with QA review of production records and Lab reports.
• Investigates non-conformance and deviation reports.
• Coordinates the stability studies including reviewing laboratory reports for accuracy and preparing statistical analyses of decay curves.
• Review test results for and release raw materials.
• Audits production and quality control programs, reports observed deficiencies, and contributes to establishing solutions to observations.
• Issues batch records, checks yield and reconciliation calculations, and fiels records for easy retrieval.
• Manages validation programs related to manufacturing equipment and processes and calibration of physical testing equipment.
• Receives, logs, investigates, and reports on complaints and adverse events; coordinates responses with QA Manager.
• Creates and revises  standard operating procedures as necessary.
• Assures compliance with cGMP regulations and all standard operating procedures.
• Assist in preparation for internal, customer and agency audits.
• Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures.
• Assist with raw material management systems.
• Use of statistical process control to evaluate tends.
• Other related duties as required.

REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS: 

• Bachelor’s degree in a scientific discipline or 4 years experience in a quality control or quality assurance function associated with manufacturing.
• Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations.
• Strong communication skills, both written and verbal.
• Ability to effectively present information and respond to questions.