Specialist, QA Auditor
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 will work closely with peer training specialists to ensure compliance with cGMPs prior to assigning personnel to areas. The QA Auditor, Specialist is the department SME and will have in-depth knowledge of area SOPs to help guide personnel throughout the production day. They are also expected to analyze, present and propose department processes and technologies to determine improvements to processes, equipment, and automation to optimize processes, meet present and new regulations, reduce waste, increase capacity, and develop and implement methods to increase output while complying with cGMP's. The QA Auditor Specialist will qualify to perform all QA Auditor tasks and processes.
- Complete inspector qualification program for manual and semi-automated inspection.
- Inspector qualification must be maintained 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 of time (12 hours/day, with appropriate breaks).
- Assure that 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 ranging in size from 5 to 10 team members.
- Partner with training peers to drive training of team members.
- Write clear, concise memos for associated tasks.
- Write/collaborate on department applicable SOPs.
- Schedule auditor personnel/tasks.
- Train or schedule training for Auditors.
- Fluent in: SAP, Trackwise, MasterControl, ComplianceWire.
- Initiate/complete deviations, CAPAs, Change Controls per the 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.
- Associates of Science required, bachelor’s degree desired.
- Minimum 5 years related experience required (with no degree).
- Minimum 3 year 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 Management of Conflict and Influencing Outcomes Desired.
- Differing Situations: Search for Solutions or New Applications Desired.
- Ability to identify problems and effectively seek solutions.
Physical Requirements
- Ability to lift 40 pounds unassisted.
- Prolonged sitting and standing.
- Manual dexterity.
- Repetitive Activity (Data Entry).
Location
Spokane, WA — On Site, Full-Time Shift: Friday-Sunday
Compensation & Benefits
- Hiring Wage: $64,477.98 – $87,228.27, with opportunities for growth, promotion, and annual raises.
- Starting on your first day, you receive: 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.
EO/Equal Opportunity 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.