AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .

SUMMARY:

The Quality Control Supervisor will provide leadership for the 24/7 function within Quality Control. This position will provide direction for execution of manufacturing support activities within the Quality Control department including sample management, real-time testing, cleaning verification and facility release support.  The ideal candidate will be an expert in laboratory operations and developing interdepartmental relationships.  This will be a Friday – Monday, Night Shift, 6:00 pm- 5:00 pm position.

 

PRINCIPLE RESPONSIBILITIES

  • Supervises daily operations for a team comprised of support and professional employees.
  • Provides technical leadership for staff usage of LIMS and Sample Management processes.
  • Provides technical leadership for performance of real-time analytical testing and facility release microbial testing.
  • Assists in the scheduling and review of product testing across multiple shifts.
  • Prioritizes and assigns project goals; ensures tasks are completed and work area goals are met.
  • Coordinates with other supervisors and teams to meet the business need and output requirements.
  • Train, coach, and mentor team members on task and skill proficiency and performance with manager’s guidance.
  • Develop staff (i.e. set goals, assign development activities, review performance, etc.).

KNOWLEDGE, SKILLS & ABILITIES:

 

  • Extensive experience with LIMS and sample management processes
  • Extensive experience with cGMPs and ability to conduct investigations
  • Extensive experience with analytical techniques such as UV Spectroscopy, TOC, pH and Osmolality
  • Detailed understanding of data integrity requirements for GMP operations, including 21CFR Part 11
  • Demonstrated ability to work effectively on cross-functional teams and engage with external clients

EDUCATION & EXPERIENCE

  • BS/BA degree with 5+ years of industry experience, or
  • Master’s degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
  • Minimum of 2 years supervisory experience

 

This is an official AGC Biologics Human Resources Document and is intended for internal distribution to company employees only. Any external use or distribution of this document is prohibited without the express approval of the Human Resources Department. This job description has been designed to indicate the general nature and level of work performed by employees in this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

 

 

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