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).

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

• 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.