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Quality Assurance Analyst
2 months ago
The individual selected for this position will be an integral part of a dedicated team tasked with ensuring the quality of cGMP mRNA drug products manufactured at this facility. This role requires providing quality oversight and expertise to facilitate technical success while strictly adhering to a Quality System that aligns with global regulatory standards. The ideal candidate will possess experience in quality oversight or manufacturing within early-stage clinical products. They should be adept at collaborating with peers and supervisors in Manufacturing, as well as cross-functionally with Quality Control, Logistical, and Process Development Technology Transfer teams.
Key Requirements:- 2-4 years of experience in a GMP Manufacturing setting
- Bachelor's degree in a science-related discipline
Compensation: $55 - $56 per hour
Shift: First
Work Hours: 8 AM - 5 PM
Education: Bachelor's Degree
- Exhibit a comprehensive understanding of standard manufacturing compliance, quality disposition, and quality system evaluations.
- Assist in identifying, classifying, and reporting deviations as necessary.
- Review manufacturing deviations and ensure compliance with current good manufacturing practices, SOPs, and manufacturing documentation, including promoting proper clean room behaviors.
- Conduct detailed reviews of deviations and corrective actions, working closely with the manufacturing team to ensure timely completion of quality records.
- Provide quality supervision during the execution of corrective actions and preventive actions (CAPA) and assess the effectiveness of these measures to maintain production continuity or advance processes to subsequent phases.
- Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records.
- Uphold data integrity principles.
- Perform additional duties as assigned.
- Quality Assurance (minimum of 2 years of experience required)
- GMP
- CAPA
- Process Improvement
- Batch Record Review
- SAP
- Veeva
- Years of experience: 2 years
- Experience level: Experienced
Randstad is a global leader in connecting talented individuals with outstanding companies. Our dedicated agents are committed to understanding your employment needs and working diligently to align your skills and qualifications with the right opportunities.
Equal Opportunity Employer: We are committed to providing equal employment opportunities to all individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, protected veteran status, or any other legally protected group status.
At Randstad, we embrace diversity and strive to ensure that our hiring and interview processes accommodate all applicants. If you require reasonable accommodations to enhance your application or interview experience, please reach out to us.
Compensation for successful candidates will be determined based on various factors, including education, work experience, work location, specific job duties, and certifications. Randstad also offers a comprehensive benefits package, including health benefits, an incentive and recognition program, and 401K contributions (subject to eligibility).
