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Quality Control Technician

2+ years
Not Disclosed
10 Dec. 11, 2024
Job Description
Job Type: Full Time 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

Job Title: Quality Assurance Specialist – Medical Device
Location: United States (On-site)
Employment Type: Contract
Job Category: Scientific
Posted: 12/10/2024
Job Number: 616527
Remote: No
Country: United States

Job Description:

Planet Pharma is seeking a Quality Assurance Specialist for a contract position in the medical device industry. In this role, you will be responsible for supporting product testing, conducting audits, reviewing production batch records, and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). This position involves working with returned instruments, decontaminating and inspecting them, and ensuring accurate documentation.

Responsibilities:

  • Conduct product testing, support complaint investigations, and verify product stability.
  • Review and approve production and finished goods batch records for accuracy and compliance.
  • Participate in the internal audit program and conduct spot-check inspections of production operations.
  • Write, review, and approve Standard Operating Procedures (SOPs).
  • Support the Document Control program, record retention, and sample retention areas.
  • Process returned instruments, decontaminate, inspect for damage, and document results.
  • Handle instrument documentation for repair and assist with packing instruments for return.
  • Other duties as assigned by the supervisor.

Qualifications:

  • Education: Bachelor’s degree in a scientific or technical area or equivalent combination of experience and education.
  • Experience: At least 1 year of experience in a quality assurance role in the medical device industry is preferred.
  • Skills:
    • Ability to follow GMP and GLP procedures.
    • Ability to interpret safety rules, operating instructions, and procedure manuals.
    • Strong attention to detail and ability to accurately document results.
    • Proficiency with database, inventory, spreadsheet, and word processing software.
    • Ability to apply mathematical concepts such as ratios, percentages, and proportions.

Physical Demands:

  • The role involves sitting and standing for extended periods and occasional walking.

Pay:

  • Hourly Pay: $20 - $22 per hour (based on experience).

Apply Now:

If you have experience in quality assurance within the medical device industry and meet the qualifications, apply today!