Quality Assurance Specialist II

Aptask Global Workforce (AGW) is seeking a Quality Assurance Specialist II for an onsite, 12+ month contract position with a leader in the biopharmaceutical industry located in Oceanside, CA.

The standard work week for this position is Monday-Friday; however, weekend/night work will be required during manufacturing campaigns to support process operations.

Responsibilities:

• 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 to 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

Requirements:

• Master's Degree OR
• Bachelor's Degree and 2+ years of experience in the biological sciences or related field OR
• AA 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, PowerPoint and other applications
• Experience with quality management systems (e.g., Veeva), project management tools, and LIMS is highly desirable
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• 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 https://www.agwtalent.com/.

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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