Team Member, Manufacturing ​/ Production

Manufacturing QA Technician

This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning policies and procedures, to maintain compliance with quality standards and FDA regulations. The incumbent plays a critical role in assuring sanitary conditions of the controlled areas are maintained, to allow for the manufacturing of biopharmaceuticals. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment are maintained.

Appropriate room and equipment sanitization records are neat and accurate, and that professional behavior is always displayed within the controlled areas.

• 6AM-2:30PM
• Sun-Thurs or Tues-Sat
• The incumbent may be required to work weekends, holidays, and overtime if required. Incumbent must join Local SIEU within 90 days. Day, Swing, Grave, Weekend shifts are available. This is a full time, non‑exempt position.

• Perform sanitization and cleaning per governing SOPs in GMP spaces
• Sanitization activities will be performed with ceiling mops, wall mops, floor mops, and wipers
• Responsible for verifying that the proper sanitization disinfectant rotation is followed, and that the proper sanitization disinfectant is used for each cleaning assignment
• Strictly follow Standard Operating Procedures
• Responsible for completing required GMP documentation to ensure records are properly and accurately maintained
• Responsible for disposal of waste from GMP manufacturing process area waste receptacles daily
• Responsible for organization and upkeep of sanitization supply areas
• Participate in required training on the use of sanitization disinfectants and equipment
• Understands and follows proper solvent handling procedures (EHS) and personal protective equipment (PPE)
• Performs related duties as assigned

• Accurate GMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)
• Communicating clearly and concisely, both orally and in writing
• Ability to read, write and understand documentation in English
• Ability to work in a team environment and independently
• Establish and maintaining collaborative working relationships with internal and external customers
• Providing excellent customer service with both internal and external customers
• Current Good Manufacturing Practices (cGMP) is a plus but not required
• Good Documentation Practices (GDP) is a plus but not required
• Company policies and practices, including safety rules and regulations

• High School Diploma or equivalent
• Prior experience of cleaning a biopharmaceutical GMP controlled environment
• English usage, reading and writing
• Computer experience
• Attention to detail is required
• Excellent attendance record
• Must follow work instructions

• No makeup, nail polish, and/or jewelry may be worn in the GMP process areas
• Incumbent is subject to extended periods of standing, walking, pushing, and pulling, bending and crouching, climbing, and lifting of equipment and/or materials weighing up to 50 pounds
• Continuous mental and visual attention to manufacturing functions
• Continuous standing and walking throughout workday
• Majority of time spent fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles and/or face shield
• Working in the ancillary support space adjacent to the GMP areas described above to ensure cleanliness

44,720.00 – 49,920.00 USD per year

On‑site – Berkeley, CA

• 401(k) plan with matching company contributions
• Comprehensive Medical, Dental & Vision Care
• Paid parental leave at 100% of salary
• Paid Time Off and Company Holidays