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QA Specialist - I

Fladger Associates

San Mateo, CA

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Cancer, Change Control, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Documentation, Establish Priorities, GMP (Good Manufacturing Practices), Interpersonal Skills, Manufacturing, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Operations Management, Order Picking/Packing, Presentation/Verbal Skills, Problem Solving Skills, Process Control Engineering, Process Validation, Quality Assurance, Quality Management, Records Management, Team Lead/Manager, Team Player, Test Lab, Time Management, Writing Skills
LOCATION
San Mateo, CA
POSTED
3 days ago

El Segundo, CA

Contract Duration: 5-18 months

Rate: Negotiable

Salary: NA $1.00

Responsibilities:

  • Excellent employment opportunity for a QA Specialist I in the El Segundo, CA area.
  • We are seeking a highly motivated individual for the roleof 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.
  • 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.
  • 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.
Experience:
  • Bachelor's Degree in the Biological Sciences or related field and minimum of 2 years of 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.
  • 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
  • Schedule: 9:00AM - 5:30PM (Monday to Friday)
  • Must Be on-site.
  • Weekend work and alternate shift may be required

About the Company

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Fladger Associates