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Manufacturing Associate

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 07/11/2019 Job Type: Scientific Job Number: JN -072019-25212
  • Provides Technical Manufacturing Services in a regulated FDA licensed & ISO certified facility, including cross-functional activities associated with production runs in collaboration w/all manufacturing groups, role may include special projects (process development & validation activities where scientific research principles are applied).
  • Works as part of a team to provide technical services & support to manufacturing areas according to standard operating procedures.
  • Performs SAP duties including cycle counting, reservations, issuing to process orders, & charging of expiring materials. Participates in equipment & process qualification & troubleshooting
  • Performs specific glassware & reagent preparations per local procedures.
  • Proficient at multi-tasking & making multiple preparations, able to switch between glassware & reagent prep functions
  • Orders materials & components in preparation for assigned production runs
  • Assembles, completes & reviews lot-specific batch record packets.
  • Responsible for 5S duties related to maintenance of manufacturing labs.
  • Maintain safe work environment complying with biohazard & chemical safety procedures.
  • Performs all manufacturing operations under cGMP/ISO requirements.
  • Adheres to valid manufacturing procedures & documentation.
  • Performs legible, clear & concise data entry into batch records, logbooks, & all other ancillary controlled forms used in a cGMP process.
  • Completes all training documentation w/in pre-defined timeframe.
  • Analyzes in-process samples generated from production activities
  • Completes all required documentation for proper traceability of production lots.
  • Operates a variety of basic lab equipment (pH meters, conductivity meters, balances, centrifuges, spectrophotometers, autoclaves, & glassware washers)
  • Performs standard laboratory operations: dispensing chemicals, volumetric & gravimetric measurements, preparing buffers & solutions.
  • Works well in team environment, utilizes project management skills to oversee completion of production lots.
  • Complies with cGMP & ISO requirements.
  • Maintains accurate documentation related to manufacturing process.
  • Demonstrates leadership skills to train & guide fellow associates.
  • Computer knowledge required (MS Word & Excel)
  • Comply with cGMP/ISO requirements
  • Maintain accurate documentation related to manufacturing process
  • Good documentation skills
  • Good attendance record
  • 1-3 yrs experience in GMP environment
  • Experience following SOPs
  • Excellent verbal & written communication skills
  • Knowledgeable in SAP a plus
  • Computer knowledge required (Word & Excel)
  • Detail-oriented, accurate documentation skills, excellent organizational skills
  • Experience w/preparation of reagents following manufacturing instructions
  • Deliver quality products & services on time to all customers.
  • Effective time management
  • Independent thinking & considers overall impact of our product for internal & external customers.
  • Monitor processes & products for continuous process improvement.
  • Able to lift & push up to 35 lbs
  • Track & order raw materials from the warehouse. Restock lab drawers
  • Associate or Bachelor s degree in one of the biological or physical sciences
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