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QA Technical Manager

QA Technical Manager

FurstStaffingSouth Beloit, IL, US
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Job Description

Job Description

The Technical Manager will oversee the stability testing program, ensuring compliance with GMP and regulatory requirements. This role involves managing analytical testing review, addressing out-of-specification (OOS) results, and reviewing lab testing and product development reports. The ideal candidate will have extensive experience in the pharmaceutical or food industry, with a strong understanding of good laboratory practices (GLP).

Key Responsibilities :

  • Lead and manage the stability testing program, ensuring compliance with GMP and regulatory standards.
  • Review and interpret analytical testing results, addressing any OOS findings.
  • Manage outside laboratory testing and ensure accurate and timely reporting.
  • Evaluate the reactivity of plastic components based on their type and ensure compatibility with products.
  • Collaborate with cross-functional teams to support product development and stability testing.
  • Maintain detailed documentation and ensure all records are compliant with regulatory requirements.
  • Provide technical expertise and guidance on stability testing and analytical methods.
  • Audit outside laboratories.
  • Stay updated on industry trends and regulatory changes to ensure ongoing compliance.

Qualifications :

  • Minimum of 7 years of experience in the pharmaceutical or food industry.
  • Strong background in GMP, GLP, and regulatory compliance.
  • Proven experience in analytical testing and handling OOS results.
  • In-depth knowledge of plastic components and their reactivity.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficient in Microsoft Excel.
  • Bachelor's degree in Analytical Chemistry, Pharmaceutical Chemistry, or a related field
  • We offer Medical, Dental, paid time off, paid holidays and more!

    For more information, please call Melissa @ 815-997-1442

    #FPTECH

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