Senior QC Data Reviewer - Stability & GMP Lead (2nd Shift)

Avecia Pharma; Milford (MA); On-site; USD 91,000 - 112,000; Full time

Benefits offered by this job

Shift differential (10%)

Job summary

Avecia Pharma is seeking a Quality Data Reviewer to act as a GMP and technical leader on review of quality data, stability batches, COAs, and data summaries. The role supports investigations and CAPAs with QA to ensure timely release and closure of stability batches.

The position is 2nd shift with a 10% shift differential, requiring strong analytical skills and experience with HPLC, LCMS, and ICH/CFR guidelines to maintain product quality and compliance.

Qualifications

• BS in Chemistry or related field; 8+ years' experience or MS with 5+ years' experience
• BS/MS in chemistry, biology, or related discipline
• 8+ years' experience as QC chemist/analyst
• Interpersonal skills to lead and train QC staff
• Experience with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UV/Vis), proficient in LCMS
• Familiarity with ICH and CFR guidance

Responsibilities

• Review quality data and reports for compliance against specifications and GMP.
• Author stability reports, COAs, data summaries, SOPs, deviation, and OOS investigation reports as needed.
• Provide training and guidance to other analysts
• Ensure safety and contribute to EHS performance

Skills

Interpersonal leadership

Training others

Education

BS in Chemistry or related field

MS in Chemistry or related field

BS/MS in chemistry/biology or related discipline

Tools

HPLC

Karl Fischer

Spectrophotometry UV/Vis

LCMS

Job description

Avecia Pharma is seeking a Quality Data Reviewer to act as a GMP and technical leader on review of quality data, stability batches, COAs, and data summaries. The role supports investigations and CAPAs with QA to ensure timely release and closure of stability batches.

The position is 2nd shift with a 10% shift differential, requiring strong analytical skills and experience with HPLC, LCMS, and ICH/CFR guidelines to maintain product quality and compliance.