This position will report to the Quality Assurance Manager. The position is responsible for corporate supplier quality to ensure that all critical supply vendors have been approved either through paper or onsite audits depending on vendor criticality. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites.
Essential Functions of the Quality Assurance Specialist Supplier:
· Evaluating, selecting and monitoring supplier performance.
· Maintain and perform supplier assessments of Tier 1, 2, 3, 4 vendors.
· Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met.
· Draft, review or approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures.
· Evaluate and write validation protocols including commercial batch and stability test methods as well as sterilization techniques for consumables, containers and finished drug products. Also, provide support to equipment validation and subsequent quality dispositioning.
· Review and approve criteria for analyses carried out under contract through private labs. Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are performed.
· Review and approve investigations of reprocessing/rework of products, complaints, analytical failures, and returns/salvages
· Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
Job Function List is not all inclusive
EXPERIENCE AND NECESSARY SKILLS:
· Able to identify potential adverse issues
· Excellent organization and documentation skills
· Detail oriented
· Computer skills, including Microsoft Word and Excel
· BS or BA degree (in a scientific discipline desired)
401(k) matching, Dental insurance, Disability insurance, Employee assistance program, Flexible spending account, Health insurance, Health savings account, Life insurance, Paid time off, Referral program, Vision insurance
SCHEDULE: Day Shift, Monday- Friday