As the Senior Quality Assurance (QA) Associate OR Manager, you will prepare for and participate in validation activities, audits and inspections. You will ensure compliance with applicable regulatory requirements including setting of QA targets. You will write SOPs and Work Instructions, and ensure compliance with SOP training and utilization and will assist with the creation of study-related quality assurance planning.
Specific tasks would include:
- Contributes to the Audit program.
- Conducts audits and follows up.
- May be responsible for QA tasks pertaining to validation and change control.
- May write and revise Controlled Documents.
- Captures QA metrics; assists in analysis and reporting.
- Provides QA surveillance for clinical trials on basis of Risk Assessment.
- Hosts and participates in client audits and inspections, reviews audit responses.
- Analyzes feedback questionnaire data and addresses responses.
- Performs follow-up to issue resolution, ensuring CAPAs are created as needed, followed, and closed.
- Offers support and training to departments involved in clinical trial oversight.
- As required, assists QA Director with budgeting.
- Serves as back-up to other QA team members across job functions as needed.
- Supervisory responsibilities include providing guidance, direction and training to select personnel on tasks to be performed as well as timekeeping and performance management.
- Bachelor’s degree in a related field of study and 5+ years’ experience, or equivalent combination of studies and relevant work experience inclusive of substantial quality management oversight and and the demonstrated ability to manage results in terms of costs and/or methods and employees effectively.
- Expansive knowledge of Quality Management Systems.
- Advantageous: passed training in QA Systems according to ISO9001.
- ICH-GCP body of knowledge and the conduct of clinical trials.