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    Associate Ii, Compliance - Qa

    Prostaff Solutions Inc
    5+ years
    Not Disclosed
    Brunswick
    10 July 3, 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

    Job Summary: Associate II, Compliance

    Direct Hire

    Pay Rate: Depending on Experience

    Company Overview: Join a dynamic team committed to maintaining high standards of quality and compliance in the pharmaceutical industry. Our organization is dedicated to ensuring adherence to cGMP regulations and internal quality procedures, supporting global operations with a focus on excellence and continuous improvement.

    Job Description:

    The Associate II, Compliance plays a crucial role in overseeing and maintaining site compliance with cGMP regulations and internal quality procedures. This role involves managing investigations, product quality complaints, CAPAs (Corrective and Preventive Actions), deviations, and change controls. The Associate II ensures strict adherence to SOPs and policies and provides support during regulatory audits, corporate audits, and internal inspections.

    Areas of Responsibility:

    • Conduct investigations into site incidents, deviations, and product quality complaints using TrackWise system, ensuring thorough root cause analysis and final review.
    • Implement and manage a robust deviation management program to identify and complete effective corrective and preventive actions.
    • Review and approve change controls, CAPAs, and global CAPAs, monitoring their effectiveness.
    • Manage quality metrics, collecting and reporting on incidents, complaints, change controls, and CAPAs on a monthly, quarterly, and annual basis.
    • Assist in preparing FDA Readiness Plans and support regulatory audits and inspections, following up on operational findings.
    • Conduct mock inspections to assess facility readiness and compliance gaps, ensuring documentation aligns with current regulations and cGMPs.
    • Identify compliance issues and support continuous improvement initiatives through process changes.
    • Support adherence to SOPs and policies, contributing to the creation and revision of SOPs as needed.
    • Review and approve qualification protocols and reports for equipment and product validations/verifications.

    Requirements:

    • Education: Minimum Bachelor’s degree.
    • Experience: Minimum five (5) years in quality roles within the pharmaceutical industry.
    • Experience in an international, multicultural matrix organization preferred.
    • Strong knowledge of Quality Management Systems (QMS) and proven ability to drive investigations to completion.
    • Thorough understanding of Good Manufacturing Practices (GMPs).
    • Proficiency in MS Office Suite, TrackWise or similar QMS, LMS (Learning Management System), and project management tools.
    • Excellent interpersonal and communication skills, both written and verbal.
    • Strong organizational and time management abilities, capable of managing multiple assignments independently or collaboratively.
    • Self-motivated with a proactive approach and a commitment to continuous improvement.
    • Intermediate-B1+ English language proficiency based on CEFR.

    Join Us: Become part of a team dedicated to upholding the highest standards of quality and compliance in the pharmaceutical industry. We offer a supportive work environment where your skills and dedication will contribute to our ongoing success.

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