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Manufacturing Associate I - Pharmaceutical Industry Fremont CA

Company name
Kelly Services, Inc.

Fremont, CA

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Job Description
Manufacturing Associate I - Pharmaceutical Industry (Fremont, CA)\r
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.\r
Must have at least 1 year of related experience working in a GMP environment!\r
Long-Term Temporary Assignment (Possible Temp to Perm)\r
Pay Rate:  $23 to 26.00/hour, depending on experience\r
Candidates must be flexible to work any shifts (day, swing or night shifts), including weekends and over time! \r
\tShifts are 10 hour shifts, 4 days a week from:  Sunday-Wednesday OR Wednesday to Saturday.  Flexibility is a must!\r
\t\t1st Shift:  6:00 am - 4:30 pm\r
\t\t2nd Shift:  2:00 pm - 12:30 pm\r
\t\t3rd Shift:  11:00 pm – 7:30 am\r
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.\r
\tExecutes 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.\r
\tPerforms in-process analytical instrument measurements e.g. pH, conductivity, temperature, pressure, among others.\r
\tDocuments execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).\r
\tPerforms internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.\r
\tEscalates to the team lead or Manager any manufacturing performance, process, or safety issues to ensure safety, regulation compliance, and to facilitate continuous process improvement.\r
\tAdherence to GMP training schedule and responsible for achieving all training requirements within acceptable timelines.\r
\tPerforms 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.\r
\tPerforms unit operations described in standard operating procedures and batch records.\r
\tRecognizes and proactively corrects errors in bioprocess operations prior to failure.\r
\tRecommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.\r
\tPerforms review of GMP documentation.\r
\tCompletes required processing documentation, including product change over and other documentation.\r
\tReviews and signs executed process and solution MBRs.\r
\tEnsures acceptable quality and quantity of work executed.\r
\tEnsures that standard operating procedures (SOPs) are followed and are correct for bioprocess operations and equipment.\r
\tEnsures compliance with company quality systems, safety procedures, and other company policies.\r
\tDemonstrates good judgment in applying industry practices and company policies to daily operations.\r
\tPerforms other duties as assigned.\r
\tAssociate's Degree in Science is a Must!\r
\tBachelor’s Degree in Science is preferred.\r
\t1 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.   \r
\tCompetency with process equipment and automated control systems\r
\tWorking experience with GMP manufacturing regulations.  \r
\tWorking knowledge of manufacturing equipment and technology\r
\tKnowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation\r
\tExperience in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.\r
\tAbility to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position.\r
\tCommunication abilities:  to read, speak, and write legibly in English.\r
\tProficiency in computer skills, including work with spreadsheet programs (Excel) and word processing (Word).\r
\tEffective time management skills.\r
\tDetail orientation with the ability to complete written and verbally assigned tasks following specific instructions and procedures.\r
\tAbility to interact constructively with peers and support groups.\r
\tOrganizational and communication skills necessary to ensure daily work plan is executed\r
Why Kelly?\r
As a Kelly Services employee, you will have access to numerous perks, including:\r
\tExposure to a variety of career opportunities as a result of our expansive network of client companies \r
\tCareer guides, information and tools to help you successfully position yourself throughout every stage of your career\r
\tAccess to more than 3,000 online training courses through our Kelly Learning Center\r
\tWeekly pay and service bonus plans\r
\tGroup- rate insurance options available immediately upon hire*\r
Apply Today!\r

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 11,000 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.

Kelly 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 2016 was $5.3 billion. Visit and connect with us on Facebook, LinkedIn and Twitter.

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.

Company info

Kelly Services, Inc.
Website :

Company Profile
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.

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