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Manufacturing Associate (Fremont, CA)

Kelly Services


Location:
Fremont, CA
Date:
04/18/2018
2018-04-182018-05-17
Job Code:
US15TPDP_BH1433886
Categories:
  • Information Systems
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Job Details

Job Title Manufacturing Associate (Fremont, CA)

Jobid US15TPDP_BH1433886

Location: Fremont, CA, 94536, USA

Description **Manufacturing Associate - Cell Inoculum (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 related experience working in a GMP environment!

1 year Temporary Assignment (may possibly extend longer)

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
**Duties:**


+ Executes routine unit operations in Cell Culture, Cell Inoculum as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This may include cell inoculation and transfer in shake flasks and wave bioreactors. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
+ Executes routine unit operations in Cell Culture such as Thaw, cell inoculation, cell separation and media batching.
+ Practices ergonomic safety and use appropriate personal protective equipment (PPE) in all operations.
+ Performs in-process analytical instrument measurements of e.g. pH, cell viability and viable cell density, osmolality, gas content, metabolites, spectrophotometry, or conductivity.
+ 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.
+ Reports any issues related to manufacturing performance, process and safety to the team lead or Manager in order to ensure safety and compliance with regulations and cGMPs and to facilitate continuous process improvement.
+ Participates in training and development opportunities in order to gain an understanding of SOPs, GMPs, regulatory compliance requirements and departmental policies.
+ Performs routine housekeeping of the manufacturing plant using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor.
+ Collaborates within team and department in order to follow best practices and meet department goals.
**Skills:**

Experience working with established GMP procedures and bulk manufacturing. Technical knowledge of manufacturing systems, methods and procedures. Understanding of cell culture processes. Possess effective troubleshooting skills with equipment and/or process.


+ Demonstrated ability to be organized and work well in small work groups.
+ Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
+ Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
+ Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
+ Demonstrated written and verbal communication skills are required.
+ Must be able to work in a team environment.
+ Experiences in related biotechnology/pharmaceutical industry strongly preferred
+ Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
+ Preferred skills include experience in: Current Good Manufacturing Practices, Mammalian cell culture, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS)

+ **Physical Demands / Surroundings** - Requires physical activity such as almost constant standing, walking, eyestrain, etc. Must be able to occasionally lift up to 25 lbs. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
+ **Visual Demands** - Position requires constant use of computer terminals and routine / repetitive work.
+ **Temperaments/Mental Requirements** - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
+ **Level of Proficiency** - Entry level in subject matter
+ **Attendance / Schedule-** The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies
**Education:**


+ Bachelors Degree with a focus in Biopharmaceuticals is a must!
**Why Kelly?**

As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Weekly pay and service bonus plans
+ Group- rate insurance options available immediately upon hire*
**_Apply Today!_**

**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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda 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 connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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