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Quality Assurance

Integrated Resources Inc
Integrated Resources Inc
3+ years
Not Disclosed
10 May 2, 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

 

Job Title

Quality Assurance


Company

Integrated Resources, Inc.


Location

Andover, MA (On-site)


Job Type

Contract


About the Company

Integrated Resources, Inc. (IRI) is a premier staffing firm founded in 1996. It is recognized for delivering top-tier talent across four core specialties:

  • Information Technology (IT)

  • Clinical Research

  • Rehabilitation Therapy

  • Nursing

IRI is known for its commitment to excellent service, integrity, and long-term client relationships.


Job Description / Responsibilities

  • Provide QA Validation support for validation activities related to Quality Control (QC) laboratory instruments

  • Review and approve documentation including:

    • Specifications

    • Executed protocols

    • Summary reports

    • Deviations

    • Periodic reviews

    • Procedures and change controls

  • Support data integrity initiatives at the site

  • Collaborate with QA Validation, Instrument Validation, and QC teams

  • Ensure compliance with regulatory requirements including 21 CFR Parts 210, 211, and 11 (Electronic Records and Signatures)


Key Skills & Knowledge

  • Strong working knowledge of global GMPs

  • Familiarity with the validation lifecycle, especially computer system validation

  • Attention to detail in reviewing documentation

  • Effective oral and written communication skills

  • Strong collaboration and interpersonal skills


Minimum Qualifications

  • Bachelor’s degree in biology, engineering, or related sciences

  • At least 3 years of experience in a pharmaceutical or biopharmaceutical company, in QA or validation roles


Preferred Experience

  • Experience working with:

    • QC instrumentation

    • Labware

    • Trackwise

    • Documentum
      (Note: Preferred but not required)


Referral Bonus

Referral bonus of $500 for successful candidate referrals.


Recruiter Contact

Jasmine Jogewar
Sr. Clinical Recruiter
Integrated Resources, Inc.
Email:
jasmine@irionline.com
Phone: 732-844-8720
Fax: 732-549-5549
Website:
www.irionline.com
LinkedIn: Jasmine Jogewar