Operational QA Coordinator

GSK • Upper Merion Township, PA

2d

About The Position

The Operational QA Coordinator will provide operational quality support to the site for new and existing products, review records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions. These actions are executed through direct intervention between this role and other staff in the facility. This role may develop, implement, and administer input and in-process electronic quality systems for the production of biopharmaceutical products, ensuring compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role provides quality decisions to project teams and to production operating teams.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Requirements

• BS or BA in Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related STEM field.
• Experience in a biologics manufacturing or quality control and may include quality systems, including validation, documentation, compliance department.
• OR in Lieu of education, 2+ years of experience in a biologics manufacturing or lab setting which may include quality systems, including validation, documentation, compliance department.

Nice To Haves

• The incumbent is responsible for adhering to all GSK safety guidelines and procedures.
• Good written communication, organizational, and computer skills. Good interpersonal and verbal skills required.
• Able to function within team-based organization.
• Able to prioritize and decide appropriate course of action.
• Effective decision maker.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.

Responsibilities

• Review production and control records using established procedures and guidelines to support lot release of raw materials, components and finished goods.
• Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods.
• Support special projects, such as validation, site priority, or new products as required.
• Assist in data collection and preparation of trend analysis reports. Review for abnormal trends or indications of major problems.
• Ensure adherence to cGMP, CFR, and other governmental regulations in order to assure quality compliance.
• Performs review of documents related to change management such as work order review.
• Perform review of technical documents such as for equipment and process validation, automation and computer validation.
• This role may manage or support closure of Quality system records including investigations, corrective and preventative actions, and lab investigations
• Update departmental documents such as SOPs as required

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees