What are the responsibilities and job description for the GMP Cleaning Manager position at Precigen, Inc?
GENERAL DESCRIPTION:
GMP Cleaning Manager will require a professional who thrives in a dynamic team environment, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will manage the team responsible for performing professional cleaning of the cGMP manufacturing clinical and commercial areas. Prior experience in cleaning cGMP manufacturing areas and labs are required.
GMP Cleaning Manager will maintain cleanliness in production, lab, and warehouse areas. This role focuses on adhering to safety and quality standards, with an emphasis on GMP cleaning operations.
DUTIES AND RESPONSIBILITIES:
- Works with Manufacturing Manager to maintain the cleaning schedule
- Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
- Train and supervise cleaning operators
- Adhere to cGMP and GDP compliance
- Perform stocking and staging of usable garments for multiple gowning rooms
- Maintains accurate and complete records
- Attends and completes all training required by Company SOPs, procedures and policies
- Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
- Works in a safe and effective manner in accordance with all company, state and federal rules and regulations
- Perform any other tasks/duties as assigned by management
EDUCATION AND EXPERIENCE:
- Minimum of 1 year management experience.
- Minimum of three - five (3-5) years’ experience in sterile or GMP cleaning operations within the pharmaceutical or biotechnology industry.
- Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves
- Ability to wear a respirator during use of certain cleaning chemicals
- Perform operations within an ISO Class clean rooms
- Employee must be able to occasionally lift and/or move up to 40 pounds
- Must be able to squat, bend, kneel, and or reach for 80% of a shift
- Must be able to stand, walk, and/or move about for 80% of a shift
DESIRED KEY COMPETENCIES:
- Familiarity with cGMPs, regulatory guidelines, and standard operating procedures.
- Knowledge of industry standards and best practices in cleaning cGMP environments and cleaning agents, is a plus.
- Clean Room sanitization experience a plus Task breakdown (by %): 75% cleaning 15% documentation 10% other duties as assigned