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Qa Lead

8+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Lead

Available in: 3 locations

Category: Regulatory/Compliance

Job ID: 25660

Description:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in approximately 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

  • Works with internal teams to progress quality issues in QMS.
  • Tracks timeliness of cases in QMS.
  • Supports teams in the creation of CAPAs.
  • Maintains a strong working knowledge of QMS.
  • Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.
  • Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.
  • Performs all other duties as needed or assigned.

Qualifications (Minimum Required):

  • A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

  • 8 years in a regulatory environment (experience in GXP roles).
  • Strong understanding of QMS and CAPA processes.
  • Ability to work well within a team environment.
  • Ability to convey key details of quality issues internally.
  • Ability to communicate quality issue summaries to clients where applicable.
  • Knowledge of GCPs/GxPs.

Physical Demands/Work Environment:

  • Tasks involve sitting in front of a terminal for many hours during the working day.
  • Travel required.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

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Accommodation Requests:
If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview, or to otherwise participate in the hiring process, please contact:
taaccommodationsrequest@fortrea.com. This email is only for job seekers requesting accommodation and should not be used to check the status of an application.