Assoc, Quality Sr - Clinical Trials
About The Position
This is the advanced level position in the Clinical Trials Quality Assurance track. Demonstrates knowledge of regulatory requirements and exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May determine methods and procedures for new assignments and provide guidance to more junior personnel. Performs duties and responsibilities with minimal supervision. Engage in planned and systematic activities to provide confidence that Pharma Services Biopharma team is fulfilling its requirements for quality and continuous quality improvement. May perform audits of laboratory and study records to ensure compliance with regulatory requirements, company standards, and study plans/protocols. Reviews policies and procedures. Demonstrate and apply knowledge of applicable regulations and industry guidance/standards (e.g., GCP and GCLP) and best practices and help maintain a state of “continual inspection readiness”. Apply knowledge of GCP and GCLP and quality management system principles on a regular basis, formally and informally.
Requirements
- knowledge of regulatory requirements
- knowledge of applicable regulations and industry guidance/standards (e.g., GCP and GCLP)
- knowledge of GCP and GCLP and quality management system principles
Responsibilities
- Engage in planned and systematic activities to provide confidence that Pharma Services Biopharma team is fulfilling its requirements for quality and continuous quality improvement.
- May perform audits of laboratory and study records to ensure compliance with regulatory requirements, company standards, and study plans/protocols.
- Reviews policies and procedures.
- Demonstrate and apply knowledge of applicable regulations and industry guidance/standards (e.g., GCP and GCLP) and best practices and help maintain a state of “continual inspection readiness”.
- Apply knowledge of GCP and GCLP and quality management system principles on a regular basis, formally and informally.
Benefits
- Medical/Prescription Drugs
- Dental
- Vision
- Flexible Spending Accounts (FSAs)
- Supplemental Health Plans
- 401(k) Plan – Company match dollar-for-dollar up to 5%
- Employee Stock Purchase Plan (ESPP)
- Supplemental Life Insurance
- Dependent Life Insurance
- Short- and Long-Term Disability buy-up
- Blueprint for Wellness
- Emotional Well-Being Resources
- Educational Assistance
- Paid time off / Health Time
- Variable Compensation Plans
- Sales Incentive Plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
