Senior (Clinical) Quality Assurance Associate / QA (Clinical) Manager

Company
Synteract
Location
United States
Salary
Competitive
Posted
24 May 2021
Closes
23 Jun 2021
Ref
28920
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior (Clinical) Quality Assurance Associate / QA (Clinical) Manager- Morrisville, NC

Office-based OR commutable to the office when required

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

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:

  • Experience in Clinical research activities/good clinical practice requirements - either as a e.g. a Clinical Trial Manager, Snr CRA, or GCP Auditor
  • Good verbal and written communication skills in a previous client facing role - ability to communicate upwards and downwards internally and externally with Synteract
  • Excellent organizational abilities
  • 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.

Qualifications
  • 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.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.