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Manufacturing Associate I

Fremont, CA 94555

Posted: 07/15/2024 Employment Type: Contract Job Category: Scientific Job Number: 610369 Is job remote?: No Country: United States

Job Description

  • Executes routine unit operations in Manufacturing Assembly and Packaging as assigned in the manufacturing of drug products in a multi-product facility.
  • Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • Assists the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing areas.
  • Supports troubleshooting of equipment.
  • Assists in the setup of automated autoinjector assembly machines, pre-filled syringe assembly machines, and semi-automated tabletop machines.
  • Retrieves components and equipment from storage.
  • Assists with equipment changeovers and minor equipment repairs/adjustments.
  • Assists with real-time identification and correction of problems, including mechanical and component issues.
  • Performs all work in accordance with Company Policies and Procedures and documents all activities in controlled documents (batch records, logbooks, or SOP attachments).
  • Assists with room cleaning in production areas, including disposal of waste and room sanitization according to safety requirements.
  • Follows controlled documents to ensure proper use and documentation of equipment, including verification of equipment calibration.
  • Completes logbooks as required.
  • Performs assembly and packaging operations and assists in visual inspection/filling operations if required.
  • Ensures components, materials, and supplies are stocked prior to assembly and packaging operations.
  • Moves product, components, and equipment within the assembly and packaging area and CNC area.
  • Communicates and hands off to relief personnel during shift changes as appropriate.
  • Maintains production areas according to predefined standards (5s).
  • Adheres to safety standards, identifies unsafe situations/habits, and escalates issues appropriately.

  • Demonstrated ability to be organized and work well in small work groups.
  • Strong mathematical skills, including the ability to perform basic arithmetic and conversions.
  • Detail-oriented with the ability to read, comprehend, and follow written instructions.
  • Excellent written and verbal communication skills.
  • Ability to work effectively in a team environment.
  • Experience in a related GMP environment within the biotechnology/pharmaceutical industry strongly preferred.
  • Basic computer skills, including MS Office (Word, Excel, Outlook) and other computer-based software.

Physical Demands / Surroundings:
  • Requires physical activity such as almost constant standing and walking.
  • Works regularly in manufacturing settings under desirable conditions with some moderately disagreeable conditions.

Temperaments/Mental Requirements:
  • Requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct.
  • Involves some contact with other departments; 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:
  • Schedule dependent on the assigned shift.
  • Attendance requirements based on general policies.

To remain in this position, employees:
  • Must obtain and maintain qualifications as required to perform assigned work.
  • Must adhere to all SOPs, company Policies and Procedures.
  • Must adhere to proper technique, proper documentation practices, and all other aspects of cGMPs.

  • High school diploma plus minimum one (1) year work experience in a GMP regulated industry.
  • Associate or Bachelor's degree from an accredited institution or biotechnology vocational training preferred.

Pay Rate Range: $20-24/hr. Salary will be commensurate with experience 
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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.