Qualty Control and Quality Assurance Jobs

The QA Operation Manager is responsible for developing, implementing and administering in-process quality systems for the production of biological products at the Marietta facility to ensure compliance with GSK internal procedures, policies, standards, FDA regulations.

RESPONSIBILITIES
• Perform assigned batch record reviews and review of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements.

Reviews batch records (MFRs, MBRs, QBRs) and gives disposition (approval, rejection, etc.) to the lot or material produced to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released.

Basic Qualifications

BS with a minimum of 8 years or MS with a minimum 6 years in QA/QC positions of increasing breadth of responsibility in the pharmaceutical or biotechnology GMP regulated industries. Degree in biology, chemistry, engineering, or other related scientific disciplines are preferred

Qualifications

A BS degree is required; preferred fields include Pharmacy, Chemistry or Chemical Engineering, or related fields.
Must have strong knowledge of and 5 years of experience in Quality Assurance and Quality Control activities.
Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills in addition to strong relationship building skills.

Qualifications

A B.S. degree is required, preferably in Pharmacy. Other science related fields will be considered.

Excellent communication skills both oral and written and a high degree of interpersonal skills, and good problem solving skills and attention to detail are required for success in this position.

Education: A completed B.S. and/or M.S. in an appropriate science or engineering discipline is required for consideration for this position.

Experience: With a B.S., a minimum of 3 years experience, and with an M.S., a minimum of 1 year of experience is required in one or more of the following areas in the pharmaceutical/chemical industry:
Product development
Technical service

Perform chemical and physical analysis on the full range of analytical samples in accordance with established procedures to support product submissions and product claims

Review and approve all sterile product production documents according to priorities established by production and the SCORE Planning process. Ensure that the compounding, filling and packaging operations for both non-sterile and sterile product lines follow the established master formula and verify all critical parameters including yields.