GMP Quality & Compliance Specialist - Data Integrity

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 65,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI facility in Riverview, Michigan is seeking a qualified Quality and Compliance Specialist to join the Quality Control team. You will review laboratory data and ensure methods and records meet GMP and data integrity standards, contributing to the release of GMP materials.

You will interact with supervisors, QA, and analytical groups to verify data, support investigations, and participate in continuous improvement initiatives related to data management and laboratory

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• Minimum two to five years of experience in using HPLC, GC, and/or related analytical techniques.
• QC data review experience a plus.
• Knowledge of ECM OpenLab, SAP, Trackwise, LIMS a plus.
• Technical Writing Experience Minimum two years of GMP laboratory experience.

Responsibilities

• Review IPC, raw materials, intermediates, and finished product analytical data, and cleaning validation/verification data according to cGMP and data integrity standards.
• Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing; interface with supervisor, analytical group, and QA.
• Review deviations for accuracy, completeness and compliance to data integrity and written procedures; review of test records and electronic data/audit trails.
• Review various data types including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing.
• Review of reports for accuracy and completeness (method validation, stability, calibration, PM reports).
• Participate in lab investigations (OOS, deviations, CAPAs) and assist in preparing new or revised documentation.

Skills

QC data review

Technical writing

GMP laboratory experience

Data integrity

Education

Bachelor’s degree in Chemistry or related field

Tools

HPLC

GC

LIMS

ECM OpenLab

SAP

Trackwise

Job description

Piramal Pharma Solutions’ HPAPI facility in Riverview, Michigan is seeking a qualified Quality and Compliance Specialist to join the Quality Control team. You will review laboratory data and ensure methods and records meet GMP and data integrity standards, contributing to the release of GMP materials.

You will interact with supervisors, QA, and analytical groups to verify data, support investigations, and participate in continuous improvement initiatives related to data management and laboratory