QA Specialist

QA Specialist
  • Competitive
    HOUR
  • Temporary
  • Marietta PA, US Marietta LANCASTER US 17547
Job Ref: JO000122444
Sector: IT
Sub-sector: IT Systems
Date Added: 01 September 2021

Description:

Role = QA Operations Specialist
Duration = Six months from start date, with possible 6-month extension
Standard Day Shift (Mon-Fri; 40 hrs/wk; 8 hrs/day)
Overtime or Weekends = Not required, but candidates should be open to it, if necessary
100% onsite work
Job Purpose:
The QA Operations Specialist provides a link between operations and the various quality systems. Primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval.
Key Responsibilities:
• Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
• Provide advice and counsel on cGMP and related quality assurance issues to the value stream
• Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
• Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, line clearance, logbook and documentation review, aseptic processing oversight, etc)
• Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
• Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
• Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate investigations to address these issues.
• Write and/or revise controlled documents in support of job responsibilities.
• Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
• Provide QA review and approval for Validation documents, PQRs and Change Controls.
KNOWLEDGE/QUALIFICATIONS:
• BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from profressional experience.
• Minimum of 3 years pharmaceutical experience in Quality Assurance preferrably in Biologics, Secondary Manufacturing or 3 years as a manufacturing technician in a Biologics Secondary Manufacturing operation.

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.

SRGTalent
01/10/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Sam Royall

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