Qualifications: Must be able to perform each essential duty satisfactorily. Associate’s Degree (AA) or equivalent experience from a two year college or technical school; or minimum of one to two years experience and or training; or equivalent combination of education and experience.

Description:  Reviews and audits documents for compliance to standard operating procedures, proper documentation methods and good manufacturing practices, maintains records in good order, assist in performance of internal audits, documents submitted for QA review for adherence to SOPs, good documentation practices and adherence to cGMPs; writes / revises SOPs as necessary, compiles trend analysis data used in monthly management reports; data to include NCRs, TDRs, QC inspection findings, daily water testing results, environmental monitoring data;  enters training information into database., initiates training records for new employees, archives training records for past employees, provides notification of training needs to managers when SOPs are revised or new employees are hired, distribute supplier surveys and completes customer surveys during customer and regulatory audits, submits to Lead Auditor, performs cGMP and GDP training for all employees.

Physical Demands: The employee must frequently lift and/or move up to 50 pounds.