GMP Quality Control Manager

Organization: 
Cayman Chemical
Job Location: 
Ann Arbor, Michigan
Job Description: 

Cayman Chemical Company is a biomedical research company based in Ann Arbor, Michigan. Cayman helps make research possible by supplying scientists worldwide with biochemical tools used to understand cancer, neurochemistry, oxidative injury, endocrinology, atherosclerosis, and other human health challenges. We specialize in assay kits for the measurement of hormones and bio-markers. In addition, Cayman offers a broad range of specialty biochemicals used as research reagents and qualified standards. Cayman performs generic drug development and production in both Ann Arbor, Michigan and Neratovice, Czech Republic.

We are currently seeking candidates for the position of GMP Quality Control Manager. The successful candidate will be responsible for:

• Manage QC group, Method Validation, Raw Materials, equipment and data systems.

• Ensure all necessary testing is carried out, completely and accurately.

• Review and approve protocols, supporting analytical data, and reports associated with method validation, testing, and release of GMP starting materials, intermediates, and APIs.

• Demonstrate technical proficiency in analytical methodology and adherence to cGMP and ICH compliance.

• Review and approve Certificate of Analysis, Certificate of Test, and stability studies.

• Assess and approve discrepancies in procedures and data.

• Participate in the quality management and control of suppliers and contractors.

• Review and approve material specifications and analysis of incoming and in process materials.

• Ensure the maintenance of the QC group, premises (laboratory), and equipment.

• Approve and monitor any contract work on laboratory equipment.

• Work with other Cayman GMP staff, project managers, manufacturing staff, and clients concerning projects and testing timeline commitments.

• Serve as QC lead on analytical projects teams and product operational teams.

• Evaluate resource requirements to support projects and assure projects remain within budget.

• Train direct reports on QC job related functions and technical methods.

• Establish and review training curricula for the QC department to develop a comprehensive QC laboratory training plan.

• Identify and implement process improvements.

Requirements: 

•Bachelor degree in Chemistry, Biology, Life Sciences or equivalent with 10-15 years of relevant experience in QC, QA, or equivalent experience in the pharmaceutical industry.
•5 to 10 years of relevant GMP QC laboratory experience and 5 years in a supervisory role, particularly in a GMP environment.
•Experience in a pharmaceutical manufacturing environment.
•Expertise in analytical analysis techniques, analytical method validation, and statistical quality control.
•Excellent knowledge of FDA and ICH cGMPs or equivalent regulations and ability to interpret and relate quality standards for implementation and review.
•Excellent verbal and written communication skills.
•Strong leadership skills.
•Able to interact, cooperate, and motivate across departments and functions.

Contact Information: 

Cayman offers two different medical plans, dental, vision and medical/dependent care flexible spending accounts. Cayman is proud of our generous paid time off plan, over 10 paid holidays per year and incredibly flexible work schedules. We also offer additional benefits including life and disability insurance, a 401k with company match, educational assistance and a variable compensation plan.

Cayman is an Equal Opportunity Employer and participates in E-Verify. You can take pride in being a member of the Cayman team and working in an environment where we truly care about our products, our research and each other.

Please apply online at www.caymanchem.com