Onsite QA Validation Analyst III – GMP/CSV Expert

Pyramid Consulting, Inc

Wilson (NC)

On-site

USD 104,000 - 125,000

Full time

36 hours ago
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Job summary

Pyramid Consulting, Inc. is seeking a Quality Assurance Analyst III for an onsite, 19+ months contract in Wilson, NC.

The role emphasizes validation oversight, regulatory compliance, and partnering with engineering, validation, and manufacturing teams to ensure quality across the site. The ideal candidate holds a science or engineering degree with 2–4 years of biotherapeutic/pharma validation experience, and is proficient in cGMP and validation lifecycle activities (URS, IQ, OQ, PQ).

Qualifications

  • Bachelor's degree in a scientific or engineering discipline.
  • 2–4 years of biotherapeutic/pharma experience with GMP commissioning/validation.
  • Hands-on qualification/validation lifecycle knowledge (URS, IQ, OQ, PQ).
  • Strong knowledge of cGMP, FDA/EMA guidelines and ISPE Baseline Guides.

Responsibilities

  • Ensure site validation programs meet regulatory and corporate requirements and Master Plans.
  • Review and approve qualification documents (URS, IQ, OQ, PQ) and reports.
  • Provide QA oversight for C&Q/CSV activities to ensure GMP compliance.
  • Collaborate with cross-functional teams to address quality issues and improvements.

Skills

Experience with Validation
Fast-paced environment
Validation equipment experience
Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Job description

Pyramid Consulting, Inc. is seeking a Quality Assurance Analyst III for an onsite, 19+ months contract in Wilson, NC.

The role emphasizes validation oversight, regulatory compliance, and partnering with engineering, validation, and manufacturing teams to ensure quality across the site. The ideal candidate holds a science or engineering degree with 2–4 years of biotherapeutic/pharma validation experience, and is proficient in cGMP and validation lifecycle activities (URS, IQ, OQ, PQ).

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