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Manufacturing Associate
Ref No.: 18-15484
Location: Novato, California
Schedule Notes
Positions may be 5 x 8 hour shift, 4 x 10 hour shift, or 3 x 12 hour shift. Operations are 24/7, so position may be for any one of several shift schedules. Shifts will be discussed at interviews. Please note candidates will receive weighted overtime for the 2nd shift (10% extra) and the 3rd shift (15% extra). Manufacturing Associates must have a degree or 1-2 years of manufacturing experience and the pay rate is firm at (USD)22.75 for all candidates to ensure internal pay equity.
PROCESS KNOWLEDGE:
Understanding of process theory and equipment operation
Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)

TECHNICAL DOCUMENTATION:
Provide feedback and/or suggested changes to operational procedures
Assist in the incorporation of new technologies, practices and standards into procedures
Capable of writing and reviewing process documents

QUALITY AND COMPLIANCE:
Understanding of cGMPs as related to Commercial Operations
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

BUSINESS:
Ability to participate on projects and contribute to outcomes
Capability to learn and support new business systems (Track wise, ERP, etc.)
Support trending of defined department metrics
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment.
• The use of personal protective equipment will be required.
• Requires various shift based work and off hours

Strong communication skills—verbal and written
Ability to work in a team environment which includes good conflict resolution and collaboration
Displays good initiative to identify areas for improvement and implement solutions