Pharmaceutical Manufacturing Associates - GMP, Filling in Fremont, CA at Apex Life Sciences

Date Posted: 10/12/2018

Job Snapshot

Job Description


Responsibilities

  • 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-tim
  • Communication and hand-off to relief personnel during shift change as appropriate
  • Assists in the filling operation
  • Assists 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. 
  • 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.

Qualifications:

  • Bachelors’ degree in a science or engineering field preferred
  • In lieu of a Bachelor's degree, will consider a minimum of an associates degree with 2 year closely related experience OR a high school diploma with 4 years  related experience in a GMP or clean room environment
  • Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
  • 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 with 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.
  • Ability to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
  • 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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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