Quality Control Analyst Job

QUALITY CONTROL ANALYST needed for a CONTRACT opportunity with Yoh's client located in BERKELEY, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Experience with a cGMP and global regulatory compliance organization is required
- Experience with protein, carbohydrate, small molecule and excipient testing of Chromatography techniques are required
- Experience with chromatography systems and software (Waters/Empower, Dionex/Chromeleon, Agilent)
- Strong technical writing skills for reports and SOPs are required.

WHAT YOU'LL BE DOING:

- Performs QC analytical laboratory testing including intermediates, final container, stability, and special testing.
- Contributes to department improvement projects, investigations, and qualification projects through change control.
- Performs analytical testing to support the release, stability, and in process testing samples, or final products and supports the release of materials for production or products for commercial use.
- Accurately follows relevant SOPs, performs all activities in accordance with cGMP requirements reports abnormalities.
- Initiates and completes laboratory discrepancy events on time.
- Documents test results to ensure completeness and accuracy per cGMPs. Keeps accurate documentation and tracks record.
- Demonstrates hands-on knowledge of operating, maintenance and troubleshooting skills for HPLC instruments as well as quality and regulatory requirements pertinent to quality control labs.
- Performs moderate to complex equipment troubleshooting.
- Performs laboratory cleaning activities.
- Gathers information necessary to support changes to existing methods according to approved procedures or instrument repair and requalification.
- Initiates Change Control requests in document management system and follows through until the completion of workflows

WHAT YOU NEED TO BRING TO THE TABLE:

- Requirements Minimum of three (3) years of experience performing relevant activities including working in a cGMP compliant environment required; thorough understanding of manufacturing process records content or manufacturing process records.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- B.S./B.A

RECRUITER:Mary Nguyen

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

J2W: SCIENTIFIC

TAX TERM: CON_W2J2WPACNW

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SFSF: LS