1+ months

Manufacturing Associate I - cGMP (Fremont, CA)

Kelly Services
Fremont, CA 94536
**Manufacturing Associate I - cGMP (Fremont, CA)**

We are proud to offer an exciting long-term temp. opportunity to work as an Manufacturing Associate at a Pharmaceutical Company located in Fremont, CA.

Must have at least 1 year of Biotech Manufacturing experience working in a cGMP facility!

Long-Term Temp. Assignment (Possible Temp to Perm Opportunity!)

Pay Rate: $23 to 26.00/hour, depending on Education and Experience

**Candidates must be flexible to work any shifts (day, swing or night shifts), including weekends and over time!**

+ Shifts are 10 hour shifts, 4 days a week from: Sunday-Wednesday OR Wednesday to Saturday. Flexibility is a must!

+ 1st Shift: 6:00 am - 4:30 pm

+ 2nd Shift: 2:00 pm - 12:30 pm

+ 3rd Shift: 11:00 pm 7:30 am


Performs production processes for GMP manufacturing operations. Operates large-scale and small-scale bioprocess equipment for purification processing. Executes routine unit operations in Purification related to the manufacturing of bulk drug substance in a multi-product facility, as assigned. This may include tank CIP/SIP, transfer, harvest, chromatography, and tangential flow filtration. Performs duties under limited supervision and according to standard operating procedures and batch records.


+ Executes routine unit operations in Purification such as chromatography, tangential flow filtration, Clean-In-Place (CIP), and Steam-In-Place (SIP) operations. Practices ergonomic safety and uses appropriate personal protective equipment (PPE) in all operations.

+ Performs in-process analytical instrument measurements e.g. pH, conductivity, temperature, pressure, among others.

+ Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).

+ Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

+ Escalates to the team lead or Manager any manufacturing performance, process, or safety issues to ensure safety, regulation compliance, and to facilitate continuous process improvement.

+ Adherence to GMP training schedule and responsible for achieving all training requirements within acceptable timelines.

+ Performs routine housekeeping of the manufacturing plant using the appropriate equipment safety signage, labeling of in-process parts & equipment, squeegeeing liquids to the floor drains, and picking up parts that have fallen on the floor.

+ Performs unit operations described in standard operating procedures and batch records.

+ Recognizes and proactively corrects errors in bioprocess operations prior to failure.

+ Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.

+ Performs review of GMP documentation.

+ Completes required processing documentation, including product change over and other documentation.

+ Reviews and signs executed process and solution MBRs.

+ Ensures acceptable quality and quantity of work executed.

+ Ensures that standard operating procedures (SOPs) are followed and are correct for bioprocess operations and equipment.

+ Ensures compliance with company quality systems, safety procedures, and other company policies.

+ Demonstrates good judgment in applying industry practices and company policies to daily operations.

+ Performs other duties as assigned.


+ 1+ Years of Experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelors degree in science related area or engineering or Associates degree in science related area or Biotech certificate or in lieu of Education requirements 3 years of experience in cGMP manufacturing environment.

+ Competency with process equipment and automated control systems

+ Working experience with GMP manufacturing regulations.

+ Working knowledge of manufacturing equipment and technology

+ Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation

+ Experience in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.

+ Ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position.

+ Communication abilities: to read, speak, and write legibly in English.

+ Proficiency in computer skills, including work with spreadsheet programs (Excel) and word processing (Word).

+ Effective time management skills.

+ Detail orientation with the ability to complete written and verbally assigned tasks following specific instructions and procedures.

+ Ability to interact constructively with peers and support groups.

+ Organizational and communication skills necessary to ensure daily work plan is executed.

**_Apply Now!_**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-11-29 Expires: 2020-01-30

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Manufacturing Associate I - cGMP (Fremont, CA)

Kelly Services
Fremont, CA 94536

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