QA Release Specialist

    • York, PA

Site Name: USA - Pennsylvania - Marietta
Posted Date: Aug 13 2020
Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this QA Release Specialist role could be an ideal opportunity to explore.

As a QA Release Specialist, you will TheQARelease SpecialistwillmakeUsage Decisionsfor manufacturedlots,includingWIPand finished products, at the Marietta facility.The position ensures release criteria have been met prior to step or final release.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practice.
  • Act as the Quality Assurance site subject matter expert for all questions and issues related to product release and SAP utilization for release activities, to include:
  • Key contact for internal departments and other sites, receive information and distribute as appropriate
  • Become the site leader in the technology - attend conferences, develop technical expertise, conduct onsite training, etc.
  • Act as the site consultant when issues arise.
  • Assist with project definition during design of projects and project effectiveness review post implementation.
  • Be owner for local SOPs on release of manufactured materialsensuring
  • Compliance with CFR requirements and GSK higher level documents.
  • Consistent useof SAP across QA Product Releasedepartments from different sites
  • Consistency/ clarity between all relevantprocesses
  • Ease of use for local departments
  • Cleartraceability,visibility and accuracy of decision making processes.
  • Ensure accurate and timely release of produced lotswithin SAPby:
  • Maintaining visibility to produced material status as it progresses through SAP
  • Understanding release criteria outside of Marietta control and identifying correct contact for updates and problem resolution
  • Escalating known issues that will hold product from release
  • Timely closure of QAInspection Plans
  • Ensuring consistent data packs for release -verifyingcompleteness of documentation -challengingvariations in SAP data or presentation - always ensuring 100% clarity onreleasabilityof a lot.
  • Manage Marietta Master Batch Records, ensuring adherence to GSK internal procedures, policies, standards and FDA regulations.
  • Assist with impact assessment of site product deviations.

Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • Minimum of5years pharmaceutical industry experiencewith ≥ 2 years in licensed bio pharmaceutical or biological products.
  • Previous QA Releaseexperience preferred.
  • 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.
  • This position is responsible for understanding biologic manufacturing processes and confirming that the output from the manufacturing process comply with regulatory requirements, GSK's quality management system and GSK specifications.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
  • BSin Microbiology, Biochemistry, Chemical Engineering or relevant technical discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.

  • Technical expertise in a biologics related discipline would enable a candidate to better understand and be capable of evaluating the impact that manufacturing process steps have on the safety, quality, purity and potency of the produced material.

  • 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 aserious commitment to accuracy, integrityand quality while meeting goals or deadlines.


Other Job-Related Skills/Background:
  • Minimum of 5 years pharmaceutical industry experience with about 2 years in licensed bio pharmaceutical or biological products.
  • Minimum of 2 years in quality organization.
  • Previous QA Release experience preferred.
  • This position is responsible for understanding biologic manufacturing processes and confirming that the output from the manufacturing process comply with regulatory requirements, GSK's quality management system and GSK specifications.
  • 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.


Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.
US work authorization is required for this role. Sponsorship is not available for this position"

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