Senior Quality Control Analyst

Avecia Pharma; Milford (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company is seeking a Senior QC Analyst to conduct routine and non-routine analyses of raw materials and finished products. The role involves developing documentation, training junior staff, and ensuring compliance with cGMP guidelines. Candidates should have a BS/MS in a relevant field and significant experience in quality control analysis.

Qualifications

• 8+ years’ experience as a QC chemist/analyst.
• Experience with authoring reports, CAPA, deviations, and SOP.
• Experience with reviewing data and reports for accuracy.

Responsibilities

• Test and analyze samples in support of project plans.
• Review analytical data for compliance with specifications.
• Provide training and guidance to other analysts.

Skills

Interpersonal skills

Analytical testing

Data analysis

Education

BS/MS in chemistry, biology, or related discipline

Tools

HPLC

Karl Fischer

Spectrophotometry (UV/VIS, IR, NMR)

LCMS

Job description

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The individual is responsible for conducting routine and non-routine analyses of raw materials, in-process materials, and finished products. This individual compile analytical data and QC reports, documents analytical procedures, and authors QA documents. The Sr. QC Analyst may review the work of other analysts, schedule work within the lab, write and review documentation and train more junior analysts.

Key Responsibilities:

• Test and analyze samples in a timely manner in support of project plans in accordance to cGMP guidelines
• Review analytical data for compliance with specifications and cGMP guidelines
• Plans and schedules work for other analysts/lab technicians
• Assist in development of experimental procedures and protocols
• Develop/revise documentation such as SOP, testing procedures and material specifications
• 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/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 author reports, CAPA, deviations, SOP, OOS and EM investigations as needed.
• Experience with reviewing data and reports for technical content and accuracy of data
• Experience and familiarity with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UV/VIS, IR, NMR), and proficient in LCMS sample analysis and data analysis.