Operational Quality Specialist (Monday to Friday 8:00am to 4:00pm)

GSK•Oak Hill, VA

6d•Onsite

About The Position

This position supports quality compliance systems and objectives within the site. The incumbent maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. Review production documents ensuring those documents are complete and accurate. Complete the final disposition of products and packaged production including raw materials and packaging components. Quarantines production if any atypical observation is made during the production process. Generates the Certificates of Analysis (CoA) and Certificates of Compliance (C of C) for the required production. Report the deviations observed. This position will interact with cross-functional groups such as Production, Quality Control, Compliance, Regulatory, EHS, and Production.

Requirements

Bachelor’s degree (BBA, BA, BS, or related field)
Two (2) to three (3) year years of experience in product disposition or similar role is desired.

Nice To Haves

Making sound and effective quality decisions using scientific judgement
Exposure to regulatory inspections and interactions with inspectors
Evaluating and continuously improving the site quality systems

Responsibilities

Review Operations Records (Manufacturing / Packaging/Incoming Materials)
Complete final disposition (Release / Rejection) for Product, Incoming Materials
Quarantine production
Perform Inspections (AQL)
Work with reserve and stability samples documentation review
Support deviations
Generates CoA and CoC
Complete the Annual Periodic Product Reviews
Write or assists in writing procedures.
Evaluates Material Variance Reports
Prepares document filing and send to Record Retention Area
Prepares Quality Alert Notification and distributes accordingly
Participating in Tier Meeting