Posted in Software 30+ days ago.
This job brought to you by eQuest
Location: marietta, Pennsylvania
Position Title: QA Release Specialist
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: 5 years
Required Education: Bachelors
Travel Required: 0%
Why GSK? Because GSK’s vaccines business puts the customer at the heart of everything we do. That’s why we define our vaccines mission as: Protecting • Human • Kind. Protecting because we strive to turn the science of immunology into high-quality, practical protection against disease; Human because we are investing time in understanding and delivering on our customers’ needs and helping them achieve their vaccination goals; and Kind because we recognize and act on our responsibilities to serve societies, rich and poor.
The QA Incoming Release Specialist will make Usage Decisions for purchased materials, including components, and raw materials at the Marietta facility. As a member of the Quality Assurance Release Office, this position will be co -responsible for the site and the department results.
• Act as the Quality Assurance site subject matter expert for all questions and issues related to incoming release and SAP utilization for release activities, to include:
o Key contact for internal departments and other sites, receive information and distribute as appropriate.
o Become the site leader in the technology – attend conferences, develop technical expertise, conduct onsite training, etc.
o Act as the site consultant when issues arise.
o Assist with project definition during design of projects and project effectiveness review post implementation.
• Be site review participant for GSOP development to provide key review output from Marietta to assure the site needs are being addressed and improve our standing with GQA.
• Be owner for local SOPs on release and sampling of purchased materials as well as QA approver / authority for SOPs relating to WHS receipt, ensuring –
o Compliance with CFR requirements and GSK higher level documents.
o Consistent use of SAP across QA Incoming Release WHS departments from different sites
o Consistency/ clarity between all relevant processes
o Ease of use for local departments
o Clear traceability, visibility and accuracy of decision making processes
• Ensure accurate and timely release of purchased lots within SAP by:
o Maintaining visibility to purchased material status as it progresses through SAP
o Understanding release criteria outside of Marietta control and identifying correct contact for updates and problem resolution
o Escalating known issues that will hold materials from release
o Timely closure of QA Inspection Plans
o Ensuring consistent data packs for release – verifying completeness of documentation - challenging variations in SAP data or presentation – always ensuring 100% clarity on whether a lot can be released.
• Act as the Quality Assurance site subject matter expert for Marietta Spare Parts, ensuring adherence to GSK internal procedures, policies, standards and FDA regulations.
• Assist with impact assessment of relevant site deviations.
• Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all GSK safety guidelines and procedures.
• Excellent organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
• Fully versed in GMP’s, NIH and WHO Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.
• Demonstrate a serious commitment to accuracy, integrity and quality while meeting goals or deadlines.
• BS or BA in Microbiology, Biochemistry, Chemical Engineering or relevant technical discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience
• Minimum of 5 years pharmaceutical industry experience with ≥ 2 years in licensed biopharmaceutical or biological products.
• Minimum of 2 years in quality organization.
• Strong SAP knowledge
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.