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    Qa Compliance Associate/ Sr.Associate

    Jubilant Pharma
    2-5 years
    Not Disclosed
    Remote, USA
    10 Jan. 27, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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: QA Compliance Associate/Sr. Associate (Fri - Sun Nights)
    Location: Spokane, WA
    Company: Jubilant HollisterStier

    Job Description:

    Jubilant HollisterStier LLC, part of the Jubilant Pharma family, is a global leader in the manufacture of allergenic extracts, targeted at treating allergies and asthma, as well as contract manufacturing of sterile injectable vials and lyophilized products. We are seeking a QA Compliance Associate/Sr. Associate to support our Deviations, Corrective and Preventive Action (CAPA) program, focusing on root cause analysis (RCA) and vendor complaints/issues, to ensure product compliance and safety.

    Key Responsibilities:

    • Review deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs, policies, and regulations.
    • Facilitate deviation investigations and resolutions, assess product impact, and provide final assessments for QA Management and client approval.
    • Enter data into databases supporting RCA and CAPA activities.
    • Provide oversight of investigational RCA activities, including meeting agendas, minutes, and follow-up on tasks.
    • Interface with management and team members to ensure task completion on schedule.
    • Ensure compliance with quality systems, processes, and procedures to maintain product quality and safety.
    • Assist in implementing corrective actions resulting from deviations, audits, or inspections.
    • Provide Deviation and CAPA metrics for management review.
    • Work with departments to ensure proper documentation of investigations or corrective actions.

    For Sr. Associate:

    • Provide training to the Quality Unit and other departments on investigation handling.
    • Represent QA during regulatory and client audits.
    • Act as the QAC Lead Associate in the absence of the QAC Lead Associate.
    • Perform special assignments as directed by the supervisor.

    Qualifications:

    QA Compliance Associate:

    • Associate's Degree in Biology, Chemistry, or related field required (5 years of experience can be used in lieu of a degree).
    • Minimum of 2 years of experience in pharmaceutical or FDA-regulated industries.
    • Experience with technical writing, investigations, CAPA systems, and quality systems is highly desired.
    • Knowledge of cGMPs desired.

    QA Compliance Sr. Associate:

    • Associate's Degree in Biology, Chemistry, or related field required. Bachelor's Degree in a science field is preferred.
    • Minimum of 5 years related experience required with an Associate's Degree. At least 2 years of experience with a Bachelor's degree.
    • Experience in pharmaceutical or FDA-regulated industries required.
    • Strong technical writing skills and experience with investigations, CAPA systems, and QC analysis.
    • Knowledge of cGMPs is required.
    • Demonstrated strong interpersonal, conflict management, and verbal/written communication skills.
    • Ability to prioritize investigations based on facility impact and batch release.

    For Both Positions:

    • Direct or supporting aseptic manufacturing experience in the bio/pharma industry desired.
    • Proficiency in Microsoft Word and Excel required.
    • Sologic Certification desired.
    • Ability to lift 30 pounds unassisted.
    • Prolonged sitting required.
    • Ability to manage conflict and influence outcomes.

    Shift:

    • Friday – Sunday Nights from 5:00 PM – 5:30 AM (3x12-hour shifts)

    Compensation:

    • QA Compliance Associate: $30.01 - $40.59 per hour
    • QA Compliance Sr. Associate: $67,725 - $102,000 annually (based on experience)

    Benefits:

    • Medical, Dental, Vision, Flexible Spending, and Health Savings Accounts
    • Life, AD&D, Short and Long Term Disability
    • 401(k) with company match
    • Generous paid time off plan
    • Employee Assistance Program
    • Voluntary Life and AD&D for employee & family
    • Supplemental Medical coverage (Critical Illness, Hospital Indemnity, and Accident coverages)
    • Pet Insurance
    • ID Theft Protection
    • Perk Spot Discount Program

    Jubilant HollisterStier is an equal opportunity employer, and we encourage all qualified applicants to apply. If you're ready to join a dynamic and rewarding team, we invite you to apply today!

    For more details and to apply:
    Click Here to Apply

    EEO/AA Employer – All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    For Assistance:
    Human.Resources@jubl.com

     

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