QA Specialist

QA Specialist
  • $1 - $46.45 per Hour
  • Temporary
  • Marietta PA, US Marietta LANCASTER US 17547
Job Ref: JO000124155
Sector: Clinical
Sub-sector: Quality
Date Added: 11 October 2021

QA Specialist

• 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 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 Clear traceability, visibility and accuracy of decision making processes
• Ensure accurate and timely release of purchased lots within SAP by:
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 release of a lot.
Knowledge/ Education / Previous Experience Required:
• BS or BA in Microbiology, Biochemestry, Chemical Engeneering 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

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

16/02/2022 12:00:00
USD 1.00 46.45 Hour
Contact Consultant:
Megan De La Hoz

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