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Pharmaceutical Manufacturing Associate - Filling
Ref No.: 18-19500
Location: Fremont, California
Duties: Two are for day shift (7:00am – 3:30 ) and one is for swing (3:30pm-12am)
  • Assists in the setup of filling room and Isolator
  • Movement of product, components and equipment within the aseptic processing area
  • Transfers product, components and equipment within the CNC, Class C and Class D processing areas.
  • Assists with the cleaning of parts and equipment
  • Assists with minor equipment repairs/adjustments
  • Assists in the identification & correction of problems to prevent down-time
  • Communication and hand-off to relief personnel during shift change as appropriate
  • Assists in the filling operationAssists the Sr. Associate and / or Master Associate with Isolator and equipment set up. This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities. Retrieves components and equipment from aseptic storage.
  • Assists the Sr. and Master Associate with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues.
  • Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
  • Assists with Isolator and room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements.
  • Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes log books, as required.
  • Responsible for performing filling operations and assisting in visual inspection operations.
  • Ensures components, materials and supplies are stocked prior to the start of the filling operations.
Skills:
  • Demonstrated ability to be organized and work well in small work groups.
  • Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
  • Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
  • Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
  • Demonstrated written and verbal communication skills are required.
  • Must be able to work in a team environment.
  • Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
  • Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
  • Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, working with hands inside an Isolator, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
  • Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
  • Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
  • Level of Proficiency - Entry level in subject matter
  • Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
  • To remain in this position, employees:
  • Must obtain & maintain qualifications, as required, to perform the assigned work.
  • Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
  • Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP's
  • Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.
Education:
  • Bachelors' degree, preferably in a science or engineering field.
  • In lieu of a Bachelor's degree, will consider a minimum of an associates degree with 2 year closely related experience in a GMP or clean room environment OR
  • A high school diploma with 4 years closely related experience in a GMP or clean room environment