Quality Data Reviewer, 2nd Shift

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

Job summary

Avecia Pharma in Milford, MA is seeking a Quality Data Reviewer to lead data review and stability reporting in a GMP environment.

You will author stability reports, COAs, data summaries, and contribute to investigations and CAPAs with QA to ensure timely release of stability batches. This is a second shift position with a 10% differential.

Qualifications

• BS in Chemistry or related field with 8+ years' experience or MS 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 (UV/NIS), and proficient in LCMS analysis and applications.
• Familiarity with ICH and CFR guidance's.

Responsibilities

• Review quality data and reports 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

Skills

Interpersonal leadership

QC chemist/analyst experience

Analytical instrumentation knowledge

ICH CFR familiarity

Education

BS in Chemistry or related field

MS in Chemistry or related field

BS/MS in chemistry or biology or related discipline

Tools

HPLC

Karl Fischer

Spectrophotometry (UV/Vis)

LC-MS

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.