Manufacturing Associate

Bayside Solutions
Published
November 13, 2021
Location
Union City, CA
Category
Job Type

Description

Job Description

  • Support Manufacturing set-up, operation, troubleshooting and dismantling equipment used for the preparation of drug delivery systems. This includes executing experimental, clinical and process validation operations, including analytical measurement and basic data analysis.
  • Interact/Support Process and Equipment Engineering, System Design Engineering and Formulation personnel to provide product support.
  • Provide support for process and equipment validation activities for cGMP operations.
  • Demonstrate ability to recognize and document equipment malfunctions and process deviations.
  • Have technical ability to work on equipment and other special assignments
  • Assist with resolving technical issues as well as maintenance of production equipment.
  • Follow all relevant standard operating procedures and complete master production records in a cGMP environment.
  • Review existing operational and processes in manufacturing and provide technical expertise to improve procedures.
  • Review Batch/Lot material issuance for completeness/accuracy and perform Batch/Lot material reconciliation as required.
  • Complete and Review batch production records to ensure cGMP documentation practices are followed and information entered is complete and accurate. Develop/revise manufacturing associated documents.
  • Train newly hired technicians and assist in cross training of other less experienced technicians.
  • Provide communication between shifts to ensure smooth and efficient transition of tasks.
  • Bring equipment and facilities issues to the attention of the Supervisor for resolution.
  • Self-motivated and be able to work with minimal supervision. Have a hands-on approach to get the job done.

Requirements:

  • Bachelor's degree or equivalent with 2+ year relevant work experience required in the medical device field or Pharmaceutical/Biotech industry required. Aseptic manufacturing experience is highly desired.
  • Experience in classified clean room manufacturing operations is required.
  • The ability to work and communicate in a safety-conscious, dynamic, project-driven team focused environment is essential. Demonstrate to be a self-motivated individual and the ability to follow directions effectively.
  • Strong mechanical aptitude and familiarity or experience in handling drug compounds, organic chemicals and solvents is required. Demonstrated basic math skills.
  • Perform duties in accordance with Current Good Manufacturing Practices (cGMP's), FDA and ISO guidelines.
  • Excellent written and verbal communication skills. Must have computer skills including Microsoft Word and Excel.
  • Must be willing and able to work flexible hours and/or overtime when required; and demonstrate the ability to perform multiple operations and/or projects simultaneously.
  • Ability to sit or stand for long periods of time. The ability to lift 35-40 lbs. is essential.
Apply
Drop files here browse files ...

Related Jobs

Manufacturing Associate   Martinez, CA new
December 5, 2021
December 5, 2021
Manufacturing Associate   Union City, CA new
December 3, 2021
December 1, 2021

Author: