Quality Assurance Specialist

United States
12 Jan 2021
11 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Quality Assurance Specialist - Morrisville, NC


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. With our mission of Bringing clinical trials to life TM , 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

The Quality Assurance Specialist contributes to Quality Assurance initiatives by developing SOPs and Work Instructions, and managing the controlled document process. S/he ensures compliance with applicable regulatory requirements including setting of QA targets and ensuring compliance with SOP training and utilization. Furthermore the QA Specialist plans, conducts, and reports audits. S/he also analyses metrics and CAPA trends and recommends process improvements.

Specific tasks would include:
  • Performs the writing and revision of Standard Operating Procedures (SOPs) and Work Instructions (WI), ensures training sessions are held on new/revised SOPs.
  • Ensures departmental WI reviews are performed per requirements.
  • Ensures SOP training is documented.
  • Supports QA management in training of staff on new versions of controlled documents.
  • Provides external SOP information to sponsors or 3rd party vendors.
  • Gathers, analyzes, and reports QA metrics.
  • Assists with issue resolution and CAPA management.
  • Analyzes trends, recommends process improvements.
  • Provides oversight of QA and Risk Management plans for clinical trials; liaise with PM/CO departments to ensure plans are completed and followed.
  • Performs oversight of feedback questionnaire process.
  • Prepares for external audits conducted by clients, potential corporate partners, or regulatory agencies.
  • Contributes to audit responses.
  • Performs follow up to ensure audit action items are closed.
  • As appropriate, analyzes trends and recommends process improvement possibilities.
  • Coordinates and conducts periodic internal audits.
  • Develops applicable documents and conducts audits related to training documentation, study files, TMF, System, or study-specific spot-check audits).
  • Provides training to local QA Compliance Officers.
  • Assists with maintenance of QA Audit Plan for internal audits.
  • May provide day-to-day guidance and direction to lower level Quality Assurance personnel.
  • Monitors changes in federal regulations and notifies relevant departments of notable changes.
  • As needed, serves as back-up to other QA team members across job functions.

  • Bachelors degree in a related field of study and a minimum 8 years experience, or equivalent combination of studies and relevant work experience inclusive of substantial quality management oversight.
  • Comprehensive 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 is required.

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.

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