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Senior Quality Assurance Associate
Payrate: $52.00 - $52.00/hr.
Summary:
This position is responsible for supporting clinical trial projects, ensuring compliance with regulatory requirements, good manufacturing practices (cGMP), and standard operating procedures (SOPs). The role involves providing regulatory expertise, maintaining site audit readiness, and ensuring the accuracy and reliability of testing methods and results.
Responsibilities:
- Ensure products are manufactured, packaged, tested, and released according to applicable procedures.
- Perform document generation and review.
- Lead investigator for deviations and complaints.
- Participate in Continuous Improvement (CI) projects with a risk-based approach.
- Support functions associated with the packaging of clinical and commercial drug material.
- Perform batch record review and in-process audits.
- Lead investigator for deviations and complaints.
- Perform shipment verification and assess incoming damaged material.
- Review and approve model protocols, randomizations, and label approvals.
- Track metrics for label control and review investigations/deviations and corrective actions.
- Participate in reported incidents to support quality compliance and business needs.
- Assist in data compilation and management support of client business and quality review meetings.
Qualifications:
- Bachelor's or Master’s degree in a scientific discipline or relevant equivalent knowledge and experience.
- 10 years of Quality Assurance experience in a GMP manufacturing environment or equivalent experience.
Desired Skills:
- Six Sigma or ASQ certification preferred.
- Ability to solve routine and non-routine problems using existing procedures and literature.
- Proactive in addressing work issues at individual, team, and department levels.
- Ability to follow and provide a variety of instructions in written, oral, diagram, or schedule form.
- Capability to identify and provide guidance/mitigation for aberrant data and potential quality/compliance concerns.
- Strong leadership capabilities and ability to collaborate in a matrix environment.
Pay Transparency: The typical base pay for this role across the U.S. is: $52.00 - $52.00 /hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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