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Manufacturing Associate

  • Location: California, United States of America, North America
  • Salary: 40-43.55 per hour
  • Job Type:Contract

Posted 15 days ago

  • Sector: Industrial
  • Start Date: 2021-10-06
  • Job Ref: 21-22258
Shift: Wednesday – Saturday 12pm – 10:30pm

Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, the Manufacturing Associate I is responsible for executing all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations.

Formulation/Filling:
• Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations
• Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply
• Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.
• Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
• Receive and distribute supplies into the manufacturing areas.
• May perform other duties as assigned.

All Areas
• Set up operations, daily maintenance, and break down of simple/routine equipment.
• Gain qualification to perform CIP, SIP autoclave, small parts preparation.
• Identify processing gaps and assist with implementation of new technologies.
• Perform minor to moderation troubleshooting
• Draft simple to moderate DCRs and complete minor Client investigations.
• Results oriented, self-motivated, and able to work independently
• Able to work effectively and efficiently in a team environment.
• Able to provide feedback for operations & elevate concerns as needed
• Demonstrate initiative, proactiveness and effective communication
• Actively seeks opportunities for personal growth and development and monitors progress toward achieving development goals.
• Proactively assists others in accomplishing work
• Listens carefully and is receptive to feedback from others.
• General knowledge of CGMP and SOPs preferred
• High school diploma or equivalent required; Bachelor's degree preferred
• 0-2 years of related work experience
• The overall physical exertion of this position requires medium to heavy work.
• May be required to gown frequently and balance when gowning into clean areas.
• May require the use of special visual or auditory protective equipment.
• May be required to work at heights above floor level.
• Will not be required to operate foot controls or repetitive foot movement.
• May be required to sit between 1-2 hours.
• May be required to climb (use step stools and ladders) or kneel up to 1 hour.
• Requires repetitive use of both right and left hands and arms up to 3-4 hours.

Formulation/Filling
• May be required to walk, stand or bend at the neck/waist for over 4 hours
• May be required to squat between 1-2 hours
• May be required to reach above/below the shoulder between 3-4 hours
• May be required to twist at the waist up/twist at the neck up to 1 hour
• May be required to lift up to 50lbs; Lifts per shift are up to 100 times.
• May be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times.
• May require simple grasping & pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours.
• May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste.
• Will require entering a 2-8 degree Celsius & -60 degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite.
• Must be able to work in controlled or clean room environments requiring special gowning.
• Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
• May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling and on-site transporting of hazardous wastes.
• May work and have exposure to hot, cold, wet environment/conditions
• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
• May be required to work in confined areas; may be required to work around moving equipment and machinery
• May be required to drive to travel to other facilities, training sites, and off-site meetings.
• Will not be required to walk on uneven ground.
• May require office work activities between 1-2 hours.
• This position requires overtime, weekend and holiday work.
May be required to work or be assigned to a different shift as needed.