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Quality Control Analyst I

2 months ago

Norton, United States Proclinical Staffing Full time

Quality Control Analyst I -Contract - Norton, MA

Proclinical is seeking a Quality Control Analyst I for a contract role in Norton, MA.

Primary Responsibilities:

This position focuses on performing various operational assignments and analytical assays to support quality control activities. The successful candidate will need attention to detail, adherence to schedules, and collaboration with cross-functional teams.

Skills & Requirements:

  • Experience in environmental monitoring and critical utility sampling.
  • Proficiency in performing analytical and microbiological assays.
  • Strong organizational skills and ability to maintain accurate training records.
  • Familiarity with laboratory equipment maintenance and inventory management.
  • Ability to ensure timely data submission and review.
  • Experience in revising and updating controlled documents.
  • Knowledge of GMP, GLP, and ICH guidelines.
  • Effective collaboration and communication skills.
  • Experience in inspection readiness and supporting audits.
  • Commitment to continuous improvement in QC processes.

The Quality Control Analyst I responsibilities will be:

  • Conduct environmental monitoring and critical utility sampling in cleanroom spaces.
  • Perform routine and non-routine analytical and microbiological assays for raw materials, in-process samples, product release, and stability studies.
  • Maintain training records, adhere to testing schedules, and ensure timely completion of assignments.
  • Assist in maintaining laboratory equipment and inventory, including reagent and sample preparation.
  • Ensure timely data submission and may qualify as a data reviewer.
  • Contribute to the revision and updating of controlled documents, including SOPs and test methods.
  • Adhere to internal standards, policies, SOPs, and regulatory guidelines (e.g., GMP, GLP, ICH).
  • Collaborate with QC and cross-functional teams to support quality control operations.
  • Participate in inspection readiness activities and support onsite audits and inspections.
  • Support continuous improvement initiatives to enhance QC processes and laboratory efficiency.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at A.Maldonado@Proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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