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Specialist, QA AuditorJubilant HollisterStier LLC • Spokane, Washington, United States
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Specialist, QA Auditor

Jubilant HollisterStier LLC
  • US
    Spokane, Washington, United States
  • US
    Spokane, Washington, United States
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À propos

Job Description The main function of the QA Auditor, Specialist & Senior Specialist is to coordinate personnel to support the CMO & ABU production schedule. This person works closely with peer training specialists to ensure compliance with cGMPs before assigning personnel to areas. The QA Auditor, Specialist serves as the department SME with in-depth knowledge of area SOPs to guide personnel. They analyze, present and propose department processes and technologies to improve processes, equipment, and automation to optimize production, meet regulations, reduce waste, and increase capacity while complying with cGMPs.
Responsibilities
Complete inspector qualification program for manual and semi-automated inspection and maintain qualification annually.
Process final container samples; perform inspection/sampling according to SOP, protocol or client request memo.
Read and follow established Standard Operating Procedures covering execution and documentation of QA auditing processes.
Complete accurate documentation of QA auditing processes on production records using GDP.
Assure that labeling and packaging lines are clean and free of materials and components from previous lots.
Perform visual inspection of product vials and packaging over extended periods (12 hours/day with breaks).
Ensure through a system of auditing that cGMPs are followed in manufacturing and finished product packaging areas.
Provide effective day-to-day leadership and oversight for small groups (5-10 members).
Schedule team members proficiently to achieve target turnaround times and meet production schedule targets.
Act as area SME for SOP updates and proposed equipment/process changes.
Partner with training peers to drive training of team members.
Write clear, concise memos for associated tasks.
Write or collaborate on department applicable SOPs.
Schedule auditor personnel and tasks.
Train or schedule training for auditors.
Fluent in SAP, Trackwise, MasterControl, ComplianceWire.
Initiate and complete deviations, CAPAs, change controls per applicable SOPs.
Participate in RCAs, CAPAs, change controls, and other process improvements.
Provide backup for QA Supervisor as required.
Qualifications
High school diploma or equivalent required.
Associate of Science required; bachelor’s degree desired.
Minimum 5 years related experience required without a degree.
Minimum 3 years related experience required with an Associate’s degree.
2 years’ experience required with a Bachelor’s degree.
Electronic documentation management system and/or LMS experience required.
Pharmaceutical experience desired.
FDA‑regulated industry experience desired.
Visual inspection qualification knowledge desired.
Lead experience desired.
Basic exchange of information.
Managing conflict and influencing outcomes.
Service oriented and problem solver.
Experience with training in corporate environments; understanding of CFR21, GDP, cGMP, ISO desired.
Basic understanding of pharmaceutical manufacturing, problem‑solving skills, and interpersonal relations.
Limited/elementary vocational knowledge required.
Advanced/specialized knowledge of aseptic process/pharmaceutical manufacturing desired.
Microsoft Word required; Excel desired.
Position requires cGMP and pharmaceutical manufacturing knowledge; auditor must recognize deficiencies in product quality and report to supervisor.
Thorough understanding of QA and manufacturing systems related to testing, packaging operation, and batch records.
Vision requirement: 14/14 Corrected Near-Point Pass Color Deficiency Test None.
Physical requirements: ability to lift 40 pounds unassisted, prolonged sitting and standing, manual dexterity, repetitive activity (data entry).
Routine environment with simple rules and detailed instructions.
Differing situations: search for solutions or new applications desired.
Ability to identify problems and effectively seek solutions.
Location Spokane, WA – On Site, Full-Time
Shift Monday-Friday, 8:00 AM – 5:00 PM
Compensation & Benefits Hiring Wage: $64,477.98 – $87,228.27, with opportunities for growth, promotion, and annual raises.
Benefits start on first day; include:
Medical, Dental & Vision coverage
Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
Life & AD&D Insurance
Short-Term & Long-Term Disability Insurance
Employee Assistance Program
Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you require assistance applying for a position, contact:
JHS-TalentAcquisition@jubl.com
#J-18808-Ljbffr
  • Spokane, Washington, United States

Compétences linguistiques

  • English
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