Kelly Services Manufacturing Associate I (Fremont, CA) in Fremont, California

Manufacturing Associate I (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

Summary

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.

Responsibilities:

  • 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.

Requirements:

  • 1+ Years of Experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelor’s degree in science related area or engineering or Associate’s 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, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

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 career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.