Assoc, Quality Sr - Clinical Trials

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.

Pay Range: $95,000 - $130,000 / year

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

• 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

Auditing & Inspections:

• Initiate and conduct audits on a periodic basis according to an established schedule/annual audit plan, e.g. audits of study data/records and documentation, Facility inspections, Validation & Qualification etc.
• Prepare written reports of findings to Management as applicable.
• May act as facilitator/host for audits by clients. Assist with preparation of audit responses and follow-up to ensure remedial or corrective action resulting from audits is completed within the specified time frame.

Participate in the Quality Management Program including, but not limited to:

• Document Review: Review
  • SOP, Study Document Review for compliance with regulation requirements, Quest corporate policy, guidance documents and industry best practice, as applicable
  • Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs) and Complaints
    (Assist project and data management teams with Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs) and Complaints
• Participate in the development of annual audit and inspection plans; assist with preparation of quality plans & annual reports, as directed.
• Collect data as directed for KPIs and Metrics for Quality Assurance Function. Provide data to Manager/Senior Manager as directed to include in metrics reports. Assist in maintaining and monitoring Quality Assurance specific quality indicators.
• Assist project and data management teams with Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs) and Complaints
• Write, review and/or revise QA SOPs.
• May respond to requests for information (client questionnaires)
• Training
• Uphold and promote Quest Diagnostics Core Values.

Other duties may be assigned

Required Work Experience:

• 4-5 years’ experience in a QA role in a GLP or GCP environment
• Experience with US and international regulations related to clinical trials, e.g. EU clinical trial regulations
• 3-4 years prior experience in health-care related field, or at a Contract Research Organization or Central Lab

Preferred Work Experience:

• Experience with Quality Management Systems applications

Physical and Mental Requirements

• Ability to sit for extended periods of time.
• May occasionally lift and/or move up to 10 pounds.
• Ability to use fine motor skills to operate office equipment.
• Ability to receive and comprehend instructions verbally and/or in writing.
• Ability to use logical reasoning for simple and complex problem solving.

Technical /Job Specific Knowledge

• Knowledge and experience with FDA regulations (GCP)
• Knowledge of 21 CFR Part 11

• Knowledge of Good Clinical Laboratory Practice guidance

• Knowledge of Quality Systems principles

Skills:

• Excellent verbal and written communication skills.

• Exceptional interpersonal skills.

• Strong influencing skills desirable

• Demonstrated ability to manage multiple activities while maintaining a high level of organization.

• Strong organizational skills; detail oriented and a self-motivated problem solver.

• Ability to adapt to changing priorities

Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Education:

• Bachelor's degree in a related scientific or technical discipline

• Quality Assurance certification, e.g. RQAP-GCP, CQA preferred