Oakland-Fremont-Pleasanton Metro Area, CA
- 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.
TOP 5 IMPORTANT SKILL SETS:
- 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