Quality Assurance Specialist II; GMP

Position: Quality Assurance Specialist II (GMP)

VARITE is looking for qualified QA Specialist – II in Oceanside, CA.

WHAT THE CLIENT DOES?
An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.

WHAT WE DO?
Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title:
Quality Assurance Specialist II
Location:
Oceanside, CA
Contract Duration: 12 months
Pay Rate Range: $40.00/hr. to $45.89/hr. on W2
Work Authorization: USC or GC
Schedule:
The standard work week for this position is M-F; however, weekend/night work will be required during manufacturing campaigns to support process operations

HERE’S WHAT YOU’LL DO
Job Description:

• We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II.
• In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
• You will be located at our Oceanside, CA site and report to the Sr. Manager of Quality Assurance Operations.

Key Responsibilities (include but are not limited to):

• Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)
• Provide Quality Oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, and Stability)
• Approve shipments and provide oversight during packaging of product
• Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls
• Ensure timely assessment and closure of Laboratory Investigations
• Ensure timely assessment and closure of batch and material hold events
• Communicate lot disposition pending issues to Management
• Provide on-the-floor QA oversight and support to ensure compliance with GMP throughout the areas
• Perform walk-throughs and process observations
• Perform Document Control administrative activities including archival and updating of site training records
• Support Regulatory Body Inspections of the facility
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Escalate issues that may adversely impact timely release of product
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution
• Generate and update procedures and forms as needed
• Perform additional duties as needed

Basic Qualifications:

• Master's Degree and OR
• Bachelor's Degree and 2+ years' experience in the biological sciences or related field OR
• AA Degree and 4+ years' experience in the biological sciences or related field OR
• High School Degree and 5+ years' experience in the biological sciences or related field

Preferred Qualifications:

• Quality Control background in Analytical, Virological, and Microbiological testing
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Proficient in MS Word, Excel, Power Point and other applications
• Experience with Veeva, Smartsheet and LIMS is highly desirable
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

BENEFITS:
We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance:
  Medical, dental, and vision coverage
• Retirement Plans:
  Participation in a company-sponsored retirement savings plan.
• Legal Service Plans:
  Offering access to attorneys for legal advice and representation.

If this opportunity interests you, please respond by clicking on Easy Apply.

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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.