Supervisor, Quality Assurance

2 weeks ago


Union City Georgia, United States Dendreon Corporation Full time
About the Role

We are seeking a highly skilled and experienced Bioassay Laboratory Manager to join our team at Dendreon Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities
  • Provide direct supervision and guidance to laboratory staff, ensuring compliance with regulatory requirements and company policies.
  • Perform assays for release, clinical, or stability testing on in-process and finished products, including Flow cytometry, ELISA, Endotoxin, Total Nucleated Cell count, Viability, and Gram Stain.
  • Act as a technical expert within a specific functional area, providing guidance and support to colleagues as needed.
  • Supervise maintenance and operational use of laboratory equipment, ensuring optimal performance and compliance with regulatory requirements.
  • Participate in the development of standards, methods, and procedures for inspecting, testing, and evaluating the quality of products.
  • Conduct and manage laboratory investigations and relevant exception reports, making recommendations for corrective action as needed.
  • Ensure in-process and finished products conform to company standards and satisfy Good Manufacturing Practice (GMP) requirements.
  • Represent QC Bioassay in cross-functional teams, projects, and GXP-related problem resolution.
  • Evaluate and develop personnel to ensure functional objectives are met, performing ongoing assessment of development and training needs of reporting staff.
Requirements
  • Bachelor's degree in a scientific discipline or equivalent.
  • Minimally 6+ years of experience in cGMP/FDA regulated industry.
  • Typically, 3+ years in a leadership role.
  • Thorough knowledge of cGMP/QSR/ICH/FDA regulations.
  • Experience with inspections/audits by the FDA and other regulatory agencies.
  • Ability to independently prioritize and successfully manage complex and competing projects.
  • Proficient in MS Office applications and MS Project.
  • Strong troubleshooting and problem-solving skills.
  • Strong team leadership and staff development skills.
  • Excellent oral and written communication skills.
Working Conditions and Physical Requirements

The ideal candidate will be able to sit or stand for extended periods of time, with intermittent walking to gain access to work areas. Finger dexterity sufficient to use a computer and to complete paperwork activities. Vision sufficient to use a computer, to read written materials, and to complete paperwork activities. Hearing sufficient to communicate with individuals by telephone and in person. Ability to lift up to 25 pounds. Limited exposure to cold temperatures and laboratory environments.



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