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QC Associate III (Fremont, CA)

Kelly Services


Location:
Fremont, CA
Date:
06/06/2018
2018-06-062018-07-05
Job Code:
US15TPDP_BH1423802
Kelly Services
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Job Details

Job Title QC Associate III (Fremont, CA)

Jobid US15TPDP_BH1423802

Location: Fremont, CA, 94536, USA

Description **QC Associate III - Pharmaceutical Industry (Fremont, CA)**

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

Long-Term Temporary Assignment (Possible Temp to Perm)

Pay Rate: $44 to $48.00/hour, depending on Experience

**Duties:**


+ Create/updates raw material (RM) specifications and SOPs as required.
+ Maintains RM released data lot packets and reports. Create RM final reports.
+ Works with SQM and Quality Compliance on material qualification.
+ Coordinates with SCM and Logistics the schedule for creation of new raw material specifications.
+ Review raw material lot packets to ensure appropriate samples are taken and tested according to specification.
+ Performs final disposition and release of raw materials in SAP.
+ Monitors material testing and release status and turnaround times.
+ Performs an Owner role for Change Controls and Deviations. Documentation:
+ Independently writes and/or updates raw material specifications and reports.
+ Responsible for ensuring all raw material documentation and reports are reviewed and are in accordance with the raw material specifications.
+ Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
+ Prepares sample reconciliation reports, periodic trend reports, generate metrics and other reports as needed. Reviews and reconciles reports with internally produced data. Maintains raw material released data lot packets and reports, creates raw material final reports.
+ Process improvement and compliance:
+ Pro-actively reviews and develops new raw material specifications, standard operating procedures, protocols etc. to ensure BI stays at the forefront of quality control practices.
+ Enters data in databases as appropriate.
+ Performs an Owner role for Change Controls and Deviations.
+ Train in other RM duties such as sampling and inspection (including packaging components) to cover for other RM members when needed.
**Skills:**


+ In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals
+ Six (6) years cGMP or appropriate experience required.
+ Knowledge of CFR, USP, and ICH required.
+ Knowledge of SAP, Trackwise and LIMS desired.
+ Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems
+ Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet time lines.
+ Demonstrated problem-detection and problem-resolution skills required
+ Physical Demands / Surroundings:
+ Lifting, carrying, pushing or pulling up to 50 pounds occasionally
+ Frequent periods of sitting, walking, and standing
+ Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
+ Occasional low level work, fine finger dexterity/ including grasping or pinching required
+ Writing and use of a computer keyboard frequently
+ Occasional use of personal protective equipment
+ Visual / Hearing Demands:
+ Color vision and depth perception required.
+ May require extended hours at a computer screen.
+ Must be able to read electronic documents of all types.
+ Hearing acuity required.
**Education:**


+ Bachelor’s Degree in a Scientific Discipline is Required.
**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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