Senior GMP QA & Compliance Specialist (Contract)

Zachary Piper Solutions

Audubon (IA)

On-site

USD 55,000 - 59,000

Full time

5 days ago
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Benefits offered by this job

Medical
Dental
Vision
401(k)
Sick Leave
Paid Holidays

Job summary

Zachary Piper Solutions is seeking a Senior QA Compliance Specialist to support a GMP-regulated pharmaceutical environment in Audubon, PA. This contract-to-hire role focuses on maintaining quality systems and regulatory compliance across deviations, CAPAs, investigations, and change controls.

The ideal candidate has a strong background in GMP/cGMP, robust documentation skills, and the ability to partner with cross-functional teams to ensure product quality and compliance throughout the QMS

Qualifications

  • Bachelor's degree or 5+ years with HS diploma/GED in a related field.
  • 3+ years of pharmaceutical QA experience with GMP/cGMP.
  • Experience with deviations, investigations, CAPAs, RCA, and change controls.
  • Strong documentation, communication, and organizational skills.

Responsibilities

  • Review deviations, investigations, and root cause analysis activities.
  • Manage CAPAs, effectiveness reviews, and change controls through completion.
  • Support QMS activities and ensure quality events are completed accurately and on time.
  • Review and approve GMP documentation and quality risk assessments.
  • Support product complaints, vendor quality issues, audits, and regulatory inspections.
  • Partner with internal teams to maintain product quality and GMP compliance.

Skills

GMP knowledge
QMS experience
Deviations management
CAPA & investigations
Change control
Documentation
Communication
Organization

Education

Bachelor's degree in Life Sciences
5+ years with HS diploma/GED

Tools

QMS

Job description

Zachary Piper Solutions is seeking a Senior QA Compliance Specialist to support a GMP-regulated pharmaceutical environment in Audubon, PA. This contract-to-hire role focuses on maintaining quality systems and regulatory compliance across deviations, CAPAs, investigations, and change controls.

The ideal candidate has a strong background in GMP/cGMP, robust documentation skills, and the ability to partner with cross-functional teams to ensure product quality and compliance throughout the QMS

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