Senior Quality Control Analyst

Nitto Avecia; Milford (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Senior Quality Control Analyst to oversee analyses of raw materials and finished products. The role involves compiling data, preparing reports, and ensuring compliance with cGMP guidelines. The successful candidate will lead a team, develop procedures, and prioritize safety in the workplace. This is a full-time position ideal for someone with extensive experience in quality control and analytical testing.

Qualifications

• At least 8 years of experience as a QC chemist or analyst.
• Experience with report writing, CAPA, deviations, SOPs, OOS, and EM investigations.

Responsibilities

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

Skills

Interpersonal skills

Report writing

Technical accuracy

Education

BSc/MS in chemistry

Tools

HPLC

Karl Fischer

Spectrophotometry

LCMS

Job description

Join to apply for the Senior Quality Control Analyst role at Nitto Avecia

We are seeking a Senior Quality Control Analyst to join our team. The successful candidate will be responsible for conducting routine and non-routine analyses of raw materials, in-process materials, and finished products. Key responsibilities include compiling analytical data, preparing QC reports, documenting analytical procedures, and authoring QA documents. The Sr. QC Analyst may also review the work of other analysts, schedule lab work, and train junior staff.

Key Responsibilities

1. Test and analyze samples promptly to support project plans, adhering to cGMP guidelines.
2. Review analytical data for compliance with specifications and cGMP standards.
3. Plan and schedule work for other analysts and lab technicians.
4. Assist in developing experimental procedures and protocols.
5. Develop and revise documentation such as SOPs, testing procedures, and material specifications.
6. Provide training and guidance to other analysts.
7. Prioritize and understand the importance of EHS, taking personal responsibility for safety and encouraging a safe working environment.

Required Skills and Qualifications

• BSc/MS in chemistry, biology, or a related discipline.
• At least 8 years of experience as a QC chemist or analyst.
• Interpersonal skills to lead and train less experienced QC staff.
• Experience with report writing, CAPA, deviations, SOPs, OOS, and EM investigations.
• Proficiency in reviewing data and reports for technical accuracy.
• Experience with analytical testing equipment and methodologies, including HPLC, Karl Fischer, Spectrophotometry (UV/VIS, IR, NMR), and LCMS analysis.

Additional Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Pharmaceutical Manufacturing