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Quality Control Associate

Roche
Roche
7+ years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Quality Control Associate – Reagent Manufacturing
Location: Tucson, Arizona, United States
Category: Quality
Job Id: 202501-102568


Position Overview:

Roche is seeking a Quality Control Associate to support its Reagent Manufacturing team. The position involves performing raw material, in-process, and finished goods testing in compliance with ISO 13485 and cGMP standards. You will be responsible for maintaining high-quality documentation, generating reports, and conducting data analysis to ensure regulatory compliance within a laboratory and manufacturing environment.

Key Responsibilities:

  • Testing & Documentation:

    • Conduct testing of raw materials, in-process materials, and finished goods in a compliant manner.
    • Document test results, complete batch records, and generate qualification test reports.
    • Maintain accurate and compliant records as part of the Device History Record (DHR) for inventory release.
  • Compliance & Equipment:

    • Ensure all equipment complies with calibration standards and maintain the laboratory environment in line with cGMP and other regulatory requirements.
    • Participate in environmental monitoring and laboratory maintenance.
  • Continuous Improvement:

    • Contribute to 6S and Lean efforts to improve operational efficiency.
    • Assist with troubleshooting manufacturing exception events and process improvements.
  • Team Collaboration & Safety:

    • Foster a safety culture, ensuring adherence to environmental guidelines and safety procedures.
    • Work in collaboration with cross-functional teams for troubleshooting and process improvements.

Who You Are:

  • Educational Requirements:

    • High School diploma required (Associate's or Bachelor's degree preferred).
  • Experience:

    • At least 7 years of relevant experience with a High School Diploma, or 3 years of experience with an Associate's degree, or less than a year of experience with a Bachelor's degree (preferred).
  • Skills:

    • Strong data analysis, troubleshooting, and problem-solving skills.
    • Hands-on experience in a laboratory, with precise manual pipetting and measuring techniques.
    • Knowledge of GLP, cGMP, and ISO regulated environments.
    • Ability to work effectively in a team, meet deadlines, and adapt to aggressive timelines.

Physical Requirements:

  • Lifting up to 25lbs may be required.
  • The work environment may require gowning, hair nets, safety glasses, gloves, and foot coverings, and handling hazardous materials.