Quality Data Reviewer, 2nd Shift

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

Benefits offered by this job

Shift differential (10%)

Job summary

Nitto Avecia in Milford, MA is seeking a Quality Data Reviewer to lead GMP data review, compile stability reports, COAs, and data summaries, and support investigations and CAPAs with QA to ensure timely release of stability batches.

This is a second shift role with a 10% shift differential; candidates should have extensive QC data experience, proficiency with HPLC, Karl Fischer, UV/Vis, and LCMS, and knowledge of ICH/CFR guidelines.

Qualifications

• BS in Chemistry or related field with 8+ years' experience or MS with 5+ years' 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 with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UVNIS), LCMS
• Familiarity with ICH and CFR guidance's

Responsibilities

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

Skills

Interpersonal skills to lead and train

Attention to detail

Education

BS in Chemistry or related field

MS in Chemistry or related field

Tools

HPLC

Karl Fischer

Spectrophotometry (UV-Vis)

LCMS

Job description

About This Opportunity

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.

About This Opportunity

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.