Manufacturing Associate -Downstream Job Fremont area,California USA,Manufacturing / Production

Position: Manufacturing Associate I-Downstream
Fremont, CA

Contract Duration: 6-36 months

Rate:
Negotiable

Responsibilities:

Excellent employment opportunity for a Manufacturing Associate I-Downstream in the Fremont, CA area.
Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility.
Performs duties under limited supervision and according to standard operating and manufacturing procedures.
Processing
Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
Performs internal support duties including stocking consumables/materials, updating controlled SOP binders appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
Executes with oversight of qualified staff fundamental tasks as CIP and SIP of 's, tanks, manufacturing equipment as well as media or buffer prep and transfer into tanks and bags.
Daily analytics and maintenance of analytical equipment.
Cleaning and setup of equipment
Quality/Compliance
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.
Reports abnormalities and deviations in a timely and accurate manner.
Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
Maintains production areas according to predefined standards (5s).
Keeps own training on track and trains other technicians and associates on operations.
Contributes to Quality activities as investigations and area walk-throughs.
Working in a highly regulated environment following all applicable Company and company Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
Strong focus on execution of routine tasks with moderate technical complexity.
Performs highly proceduralized tasks.
Basic interactions with Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control
Basic knowledge of fundamental manufacturing concepts is preferred.
Does not require extensive technical knowledge of manufacturing operations.
Executing repeatable, highly proceduralized operations.
Complex operations performed under supervision.
2nd Shift: Sunday-Wednesday, 2:00PM-12:30PM

Experience:

High School Diploma, entry level position.
Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.
Preferable one (1) or more years of experience in cGMP regulated industry
Detail-oriented with the ability to concentrate on work in a complex technical setup with a "Quality and Right the first time" mindset.
Strong written and verbal communication skills.
Ability to work with computer-based systems.
Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
Ability to work as part of a high performing team and collaborate effectively with staff.
Working in a highly regulated environment following all applicable Company and company Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
PHYSICAL DEMANDS:
- Able to lift 25 lbs.
- Use of ladder will be involved.


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