Quality Control Associate

7+ years

Not Disclosed

Basel Remote Tucson

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.

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Quality Control Associate

Job Description

Position Overview:

Key Responsibilities:

Who You Are:

Physical Requirements:

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