QA Specialist
HAYS

El Segundo, California

Posted in Recruitment Consultancy


This job has expired.

Job Info


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.

A Biotechnology Company is seeking a QA Specialist in El Segundo, CA.

Role Description

We are seeking a highly motivated individual for the role of Quality Specialist I, QA Operations to work in this exciting new area of cancer immunotherapy. This position will report to the Quality Records Team Manager of QA Operations. The role will be based in our El Segundo site and associated clinical and commercial manufacturing and testing laboratories. Weekend work and alternate shift may be required.

• Provide QA oversight and approval of deviation, OOS, and change control records. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
• Provide QA oversight and approval of CAPA and EV records. Ensure CAPAs are initiated and resolved in a timely manner.
• Ensure escalation of deviations per procedures
• Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
Additional Responsibilities may include
• Ensure process control measures are in place and followed in product manufacturing.
• Review batch-related documentation, and ensure resolution of issues to release product.
• Support, and as necessary participate in QA on the floor processes, including batch record review.
• Review and approve manufacturing production records.
• Generate and update procedures and forms as needed.
• Perform Product Disposition and Lot Closure.
• Oversee the packaging and shipping process; authorize shipment.
• Perform disposition of incoming materials, components, and labels for GMP use.

Skills & Requirements

• Bachelor's degree in the biological sciences or related field and minimum of 2 years experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Must be able to work on multiple records simultaneously and demonstrate organizational, prioritization, and time management skills.
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience with manufacturing investigations, deviations, and CAPA.
• Experience with change control practices and strategies.
• Knowledge of equipment, facility, and utility IQ/OQ/PQ.
• Proficient in MS Word, Excel, Power Point and other applications

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.
#1128378


This job has expired.

More Recruitment Consultancy jobs


Allyon
Galveston, Texas
Posted about 10 hours ago

Hotfoot Recruiters
Hillsboro, Oregon
Posted about 3 hours ago

Hotfoot Recruiters
Scottsdale, Arizona
Posted about 3 hours ago

Get Hired Faster

Subscribe to job alerts and upload your resume!

*By registering with our site, you agree to our
Terms and Privacy Policy.