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Quality Assurance

3+ years
Not Disclosed
10 March 21, 2025
Job Description
Job Type: Full Time Education: BS 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

Quality Assurance
Company: Integrated Resources, Inc. (IRI)
Location: Andover, MA
Type: Contract

Company Description:

Integrated Resources, Inc. (IRI) is a premier staffing firm recognized for its excellence and integrity since 1996. IRI specializes in providing high-quality resources across four key sectors: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description:

The Quality Assurance (QA) role focuses on providing QA validation support for Quality Control (QC) laboratory instruments. The candidate will review and approve validation documentation and support the site’s data integrity initiatives.

Responsibilities:

  • Review and approve validation documentation, including specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls.

  • Provide QA validation support for QC laboratory instruments.

  • Support site data integrity initiatives as needed.

  • Ensure compliance with global GMPs, focusing on validation lifecycle, computer system validation, 21 CFR Parts 210, 211, and Part 11 (Electronic Records and Signatures).

  • Collaborate effectively with QA Validation, Instrument Validation, and QC personnel.

Qualifications:

  • Minimum BS in biology, engineering, or related sciences.

  • At least 3 years of pharmaceutical or biopharmaceutical experience in a QA or validation role.

  • Strong knowledge of global GMPs with emphasis on validation and computer system validation.

  • Strong interpersonal, oral, and written communication skills.

  • Detail-oriented with expertise in validation documentation review and approval.

  • Experience with QC instrumentation, Labware, Trackwise, and/or Documentum preferred but not required.