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19 days old

QC Lab Analyst - Turlock CA

Kelly Services
Turlock, CA 95380
**Job Description**



Job Designation: QA/QC Analyst


Shifts: 6:30 - 3:30 or 7:00 - 4:00 Rotating


Duties:

- Analyzing in process and finished samples of products.

- Analyzing the potency or efficacy of raw materials.

- Conduct and maintain product stability program

- Conduct product validations.

- Monitor up scaling of new products.

- Monitor and manage the progress of reactor batches.

- Use experience and expertise to conduct trouble shooting.

- Provide timely results and conclusions to customers.

- Handle customer complaints.

- Testing field samples

- Preparation of reagents.

- Through inspection of packaged lots.

- Processing and proper storage of batch sheets and lab records.

- Review data for compliance with FDA, EPA, SOP and product specifications.

- Generation of weekly, monthly and other necessary lab reports as required.

- Maintenance and calibration of laboratory equipment.

- Conduct quality audits.

- Conduct and Implement APQR, CAPA and Change Control.

- Practice GMP AND GLP.

- Facilitate audits from FDA, EPA to go smoothly.

- Train and supervise new recruits in QA/QC

- Communicate progress and product issues


Base Competency

for the Role including Educational Level: - Bachelor-s Degree in Chemistry, Biology, Chemical Engineering or Life Sciences.

- Analytical Titrations, Stoichiometry, pH, Densitometry, Spectrophotometry

- HPLC and GC knowledge is a plus

- Work Experience: Minimum 0-5 years- experience, including internships or co-op experience (0-5 years in an FDA Regulated Pharmaceutical Manufacturing Facility).

- Understanding of current FDA Good Manufacturing Practices (cGMP-s) for pharmaceuticals.

- General computer literacy (i.e. Word, Excel, Power Point, Outlook, etc.).

- SAP knowledge is a plus

Personality Traits Needed: - Team Builder

- Self-Motivated

- Ability to multi-task

- Able to work unsupervised

- Strong written and verbal communication skills.

- Ability to travel as needed (travel required < 10%).

Purpose & Mission: - Day-to-day testing of laboratory testing in accordance to current USP/NF and internal testing methods).

- Communication of Quality Issues to Management.

- Provide the site-s QA Approval.

- Maintain the current GMP Quality System and update as needed.

- Provide site QA guidance to the facility.

- Additional duties as required by direct management.

Key Deliverable: - Accurate and timely testing results in the QC lab.

- Positive work environment.

- Assessment and communication of Quality and GMP Compliance issues to Management.

- Timely QA approval of required documents.

- Up to date Regulatory Agency (i.e. FDA, DEA, EPA) corrective action deliverables.

- Increased GMP compliance of the Quality System

- Fulfilling additional deliverable as required by direct management.


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






At Kelly
Services , we work with the best. Our clients include 95 of the Fortune
100 companies, and more than 70,000 hiring managers rely on Kelly annually to access
the best talent to drive their business forward. If you only make one career connection today, connect
with Kelly.






**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 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.
Posted: 2019-07-29 Expires: 2019-08-29

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QC Lab Analyst - Turlock CA

Kelly Services
Turlock, CA 95380

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