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    Quality Assurance Specialist Iii (Pharmaceutical Testing)

    Infinity Laboratories
    3-5 years
    Not Disclosed
    Brunswick
    10 July 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position: Quality Assurance Specialist III

    Company: Infinity Laboratories

     

    Position Overview:

    The Quality Assurance Specialist III will ensure systems and processes comply with internal, regulatory, and industry standards, promoting a culture of quality within the company. This role involves reporting on the Quality System's performance to senior leadership and identifying CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. The specialist will participate in internal and external audits.

    Key Responsibilities:

    • Quality Assurance Activities:
      • Ensure regulatory activities comply with internal procedures and external cGXP/ISO requirements.
      • Maintain the internal auditing program and participate in planning, preparation, and hosting of customer and regulatory audits.
      • Respond to audit reports and implement resolutions for audit findings.
      • Maintain the Management Review process and the laboratory proficiency testing program.
    • Data Collection and Analysis:
      • Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.).
      • Train laboratory personnel to help reduce quality events.
      • Monitor laboratory compliance with respect to lab cleanliness, training records, and ISO/GMP-related items.
    • Quality Event Support:
      • Support quality event investigations using formal root cause analysis tools.
      • Summarize audit outcomes and risk statements to identify uncontrolled risks within the QMS.
    • Supplier and Subcontractor Management:
      • Maintain the list of approved suppliers and subcontractors.
      • Audit various reports before issuance (e.g., analysis reports, method validation reports, research and development reports, special project reports, etc.).
      • Serve as a site contact for all quality inquiries on analytical reports and related documentation.
    • Documentation and Training:
      • Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
      • Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other Quality Assurance documents.
      • Create, revise, review, and approve newly written documents and document revisions.
      • Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
      • Train laboratory personnel in GXP/ISO procedures, practices, and guidelines.
      • Serve as a backup for all other Quality Assurance personnel.

    Qualifications:

    • Education:
      • Bachelor's degree or higher in chemistry, biological science, or life science field.
    • Experience:
      • 3-5 years of laboratory quality assurance experience.
      • Experience working in a GMP facility.
      • ISO 17025:2017 accredited lab experience preferred.
      • Moderate understanding of microbiology and/or chemistry-related terms.
      • Moderate understanding of USP/EP/JP standards and guidelines.
      • Experience with testing of pharmaceutical, cosmetic, and/or medical device products.
    • Skills and Capabilities:
      • Detail-oriented and self-initiating individual with strong interpersonal, written, and oral communication skills.
      • Strong organizational skills and ability to multitask in a dynamic, fast-paced environment.
      • Sound judgment, ambition, and quality-focused.
      • Hands-on experience with industry regulations including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, and GxP.
      • Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ).
      • Strong problem-solving skills, including root cause analysis using formal RCA tools such as Ishikawa and 5Y's.

    Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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