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Analyst II, Quality Control Raw Materials - Onsite, Mansfield MA
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Based on Massachusetts data
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$75,723 / year median in Massachusetts
-9% projected decline
Job Description
- Perform routine and non routine inspection of raw materials.
- Maintain up to date training records, adhere to the inspection schedule, and ensure timely completion of assignments to support QC activities and department quality metrics.
- Accurately document all results in laboratory notebooks, LIMS, or other controlled systems in compliance with GMP standards. Review documentation as needed to ensure timely and efficient material availability.
- Participate heavily in raw material qualification programs, including vendor and supplier qualification and material risk assessments.
- Collaborate cross functionally with Manufacturing, Materials Management, and Quality Assurance to ensure raw material availability and release timelines.
- Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to support continuous improvement and compliance with applicable quality and regulatory requirements.
- Participate in inspection readiness activities and support onsite audits and inspections as needed. Qualifications
- B.S. in Chemistry, Biology, Biochemistry, or a related scientific field. An Associate Degree, Biotech Certificate, or equivalent may also be considered.
- 3 to 6 years of pharmaceutical or biotech industry experience in a regulated laboratory setting, Quality Control, or equivalent relevant experience.
- Ability to work independently with strong attention to detail in an environment where priorities may shift.
- Good communication and teamwork abilities with the ability to work effectively in a collaborative environment.
- Ability to stand for extended periods and occasionally lift raw materials weighing up to 25 lbs.
- Knowledge of LIMS, Excel, Word, and PowerPoint is helpful.
- Perform routine and non routine inspection of raw materials.
- Maintain up to date training records, adhere to the inspection schedule, and ensure timely completion of assignments to support QC activities and department quality metrics.
- Accurately document all results in laboratory notebooks, LIMS, or other controlled systems in compliance with GMP standards. Review documentation as needed to ensure timely and efficient material availability.
- Participate heavily in raw material qualification programs, including vendor and supplier qualification and material risk assessments.
- Collaborate cross functionally with Manufacturing, Materials Management, and Quality Assurance to ensure raw material availability and release timelines.
- Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to support continuous improvement and compliance with applicable quality and regulatory requirements.
- Participate in inspection readiness activities and support onsite audits and inspections as needed. Qualifications
- B.S. in Chemistry, Biology, Biochemistry, or a related scientific field. An Associate Degree, Biotech Certificate, or equivalent may also be considered.
- 3 to 6 years of pharmaceutical or biotech industry experience in a regulated laboratory setting, Quality Control, or equivalent relevant experience.
- Ability to work independently with strong attention to detail in an environment where priorities may shift.
- Good communication and teamwork abilities with the ability to work effectively in a collaborative environment.
- Ability to stand for extended periods and occasionally lift raw materials weighing up to 25 lbs.
- Knowledge of LIMS, Excel, Word, and PowerPoint is helpful.