Sr. QC Specialist
HAYS

Santa Monica, California

This job has expired.


The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

Our Client is seeking a Sr. QC Specialist in Santa Monica, CA.

Role Description

In this role, you will be responsible for reviewing the final raw material packets and testing data before submitting to QA for final lot disposition. Also, to conduct QC sampling and inspection of incoming raw materials and submission of samples to internal and external testing labs. This individual will routinely collaborate with other functional groups at Kite, such as Supply Chain, SQM and QA to ensure timely disposition of raw materials in support of production.

• Review final raw material packets and testing data and submit to QA for final lot disposition.
• Perform QC inspection of incoming raw materials and documentation, sampling raw materials and submission to internal and external labs, coordinate shipment of samples to contract labs.
• Maintain internal and external test results, and work with internal departments on timely raw material release.
• Assist with tracking of raw materials sample requests to the Kite and 3PL warehouses.
• Support investigations with contract testing labs and Kite facilities as appropriate.
• Identify, evaluate and write investigations for LIRs, OOS's, deviations, CAPAs and change controls.
• Perform risk assessments, gap assessments for analytical methods and aim to enhance compliance and robustness.
• Compile data for trending or investigation purposes.
• As needed, perform testing of raw materials by following analytical methods: Compendial methods (pH, Osmolality, Density, Conductivity, etc.)
• As needed, maintain, calibrate and operate equipment and instruments supporting in-house raw material testing.
• Develop, revise, review and approve SOPs.
• Support team members with other duties as required, such as gathering documentation and data entry.
• Participates in regulatory audits as required.
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities, and willing to accept temporary responsibilities outside of initial job description.

Skills & Requirements

• Master's Degree and 4+ years' experience in the biotech/biopharmaceutical setting OR
• Bachelor's Degree and 6+ years' experience in the biotech/biopharmaceutical setting OR
• AA Degree and 8+ years' experience in the biotech/biopharmaceutical setting OR
• High School Degree and 10+ years' experience in the biotech/biopharmaceutical setting
• Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry is required.
• Possesses strong project and time management skills.
• Experience with compendial methods preferable
• Working knowledge of cGMP requirements and testing in clinical and commercial QC. Experience with gene and cell therapies preferable. Knowledge of analytical techniques including HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents preferred.
• Experience Identifying, writing evaluating and closing OOS's and investigations.
• Knowledgeable about Quality Systems (owning LIRs, DEVs, CC, CAPAs, etc).
• Exceptional attention to detail and ability to keep track of multiple ongoing projects
• Excellent communication and strong interpersonal skills are required
• Proficient in MS Word, Excel, Power Point and other applications
• Ability to perform duties with minimal supervision and must be adaptable to a dynamic and fast-paced environment
• Excellent interpersonal and organizational skills a must
• Experience Identifying, writing evaluating and closing OOS's and investigations
• Experience writing, reviewing, or executing standard operating procedures, protocols, and reports.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information. #1125890


This job has expired.

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