Lead QC Analyst: Data Integrity & Audit Readiness

Piramal Pharma Limited; Bethlehem (Northampton County); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Critical Care is seeking a Senior Quality Control Analyst to join our Bethlehem, PA team. The role focuses on analytical testing of in-process materials, bulk drug substances, finished products, and stability samples in support of production, packaging release, and regulatory filings.

Ideal candidates will have 3+ years in a QC lab, strong knowledge of cGMP, 21 CFR Part 11, and experience with electronic laboratory systems.

Qualifications

• Experience in quality control laboratory environments
• Strong data integrity and regulatory compliance mindset
• Ability to interpret analytical data and trends
• Proficient in using electronic laboratory systems and audit trails
• Excellent written and verbal communication skills

Responsibilities

• Perform analytical testing of in-process material, bulk drug substance, finished drug product, and stability samples
• Sampling, inspection and testing of packaging components upon receipt
• Prepare quality metrics for in-process, API, and FG turnaround times
• Investigate out of specification, out of trend, and lab deviations
• Assist in inspections, audits, and CAPA/change controls
• Maintain 21 CFR Part 11 electronic records and signatures

Job description

Piramal Critical Care is seeking a Senior Quality Control Analyst to join our Bethlehem, PA team. The role focuses on analytical testing of in-process materials, bulk drug substances, finished products, and stability samples in support of production, packaging release, and regulatory filings.

Ideal candidates will have 3+ years in a QC lab, strong knowledge of cGMP, 21 CFR Part 11, and experience with electronic laboratory systems.