QC Validation Lead — Lab Systems & Compliance

Piper Companies

Marietta (PA)

On-site

USD 66,000 - 77,000

Full time

5 days ago
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Benefits offered by this job

Medical, Dental, Vision
Retirement plans
Long-term contract

Job summary

Piper Companies in Marietta, PA seeks a QC Validation Lead to drive qualification and validation of QC lab equipment and software under GMP guidelines. This lead resource manages IQ/OQ/PQ documentation, calibration programs, and lifecycle management for lab systems including HPLC, GC, GC-MS and LIMS.

The role collaborates across QC, Quality, Engineering and IT, leads investigations and change controls, and mentors team members to ensure data integrity and audit readiness for ongoing

Qualifications

  • Bachelor's degree in Chemistry, Biology, Engineering or related field; equivalent experience.
  • 5+ years validating activities in GMP-regulated pharma/biotech environments.
  • Hands-on IQ/OQ/PQ protocol writing and execution experience.
  • Strong lab validation with HPLC, GC, GC-MS and related instruments.
  • Experience with calibration programs, lifecycle mgmt, and LIMS.
  • Proven ability to lead projects, coordinate vendors and communicate with stakeholders.

Responsibilities

  • Lead qualification and validation for QC lab equipment and computer systems (IQ/OQ/PQ).
  • Support equipment lifecycle: installation, calibration, maintenance, requalification, retirement.
  • Prepare and maintain validation docs, risk assessments, protocols, reports.
  • Support lab systems incl. HPLC, GC, GC-MS, balances, environmental chambers and software.
  • Collaborate with QC, Quality, Eng, IT, vendors, and global validation teams to ensure compliance.
  • Lead investigations, change controls, audit readiness, and data integrity initiatives; train team.

Skills

Lead project coordination
Stakeholder communication
Independent lead
Vendor coordination
Data integrity awareness

Education

Bachelor's degree in Chemistry, Biology, or Engineering

Tools

LIMS
HPLC
GC
GC-MS

Job description

Piper Companies in Marietta, PA seeks a QC Validation Lead to drive qualification and validation of QC lab equipment and software under GMP guidelines. This lead resource manages IQ/OQ/PQ documentation, calibration programs, and lifecycle management for lab systems including HPLC, GC, GC-MS and LIMS.

The role collaborates across QC, Quality, Engineering and IT, leads investigations and change controls, and mentors team members to ensure data integrity and audit readiness for ongoing

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