Onsite Senior QA Compliance Lead, GMP & QMS

Piper Companies

Audubon (IA)

On-site

USD 55,000 - 59,000

Full time

2 days ago

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Benefits offered by this job

Medical, Dental, Vision, 401(k)

Sick Leave and Paid Holidays

Paid Holidays

Job summary

Piper Companies is seeking a Senior QA Compliance Specialist to join a leading pharmaceutical organization in Audubon, PA. This contract-to-hire role supports Quality Management Systems and compliance activities within a GMP-regulated environment.

Responsibilities include reviewing deviations, investigations, CAPAs, change controls, and support for regulatory inspections. Strong GMP knowledge and documentation skills are essential; pharmaceutical manufacturing or packaging experience is

Qualifications

3+ years of pharmaceutical Quality experience with a Bachelor’s degree or 5+ years with a HS diploma/GED.
Strong knowledge of GMP/cGMP requirements.
Experience with deviations, investigations, CAPAs, RCA, change controls, and QMS.
Strong documentation, communication, and organizational skills.
Pharmaceutical manufacturing or packaging experience preferred.

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.