Quality Data Reviewer, 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

The Quality Data Reviewer is responsible for being a technical and GMP leader in the team by reviewing quality data and compiling stability reports, COAs, and data summaries. The individual provide The QC data reviewer assists in writing investigations and CAPAs and works with Quality Assurance to ensure timely release and closure of all stability batches. This is a 2nd shift position an comes with a 10% shift differential.

Key Responsibilities:

• Review quality data and reports (including stability and release) for compliance against specifications, GMP regulations, and scientific technique.
• Author’s stability reports, COAs, data summaries, Standard Operation Procedures, deviation, and OOS investigation reports as needed.
• Provide training and guidance to other analysts
• Understands the importance and priority of EHS and takes personal responsibility for their own safety; looks out for the safety of colleagues and avoidance of all incidents; willingly engages in and embraces activities to improve EHS performance in the working environment

Required Skills/Abilities:

• BS in Chemistry or related field with 8+years' experience or Master's degree in Chemistry or related field with 5+ years related work experience
• BS/MS in chemistry, biology, or related discipline
• 8+ years' experience as a QC chemist/analyst.
• Interpersonal skills to lead and train less experienced QC staff
• Experience and familiarity with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UVNIS), and proficient in LCMS analysis and applications.
• Familiarity with ICH and CFR guidance's.

The annualized salary for this position is $91,200.00 - $111,500.00.