Aptask Global Workforce (AGW) is seeking a Quality Assurance Specialist II - Onsite for a contract position with a Global Biotechnology Company located in El Segundo, CA. 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 report to the Sr. Manager of Quality Assurance Operations. The standard work week for this position is Monday-Friday, however weekend and night work will be required during manufacturing campaigns to support process operations.
Responsibilities: - Provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty
- Ensure records are properly initiated, investigated and resolved in accordance with established timelines
- Provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty
- Ensure CAPAs are initiated and resolved in a timely manner
- Ensure escalation of deviations per procedures
- Identify efficiencies in the execution of the Deviation and CAPA processes in a compliant manner
- Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues
- Additional duties as assigned
Requirements: - Master's Degree in the biological sciences or related field OR
- Bachelor's Degree and 2+ years of experience in the biological sciences or related field OR
- Associate's Degree and 4+ years of experience in the biological sciences or related field OR
- High School Degree and 5+ years of experience in the biological sciences or related field
Desired skills: - 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
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Pay range: up to $45.89 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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