Job Opening: Quality Assurance Specialist

Remedy Staffing is partnered with a manufacturing company in Tonawanda in search of a Quality Specialist 

Pay Rate: $22-$27 per hour depending on experience

Shift: Full time, 1st shift 

• Document Control Expert: Responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Management Systems. Responsibility for issuance, tracking, and control of change controls, Standard Operating Procedures (SOPs), Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions.
• Create and maintain all Certificates of Analysis (CoA’s) and other release documentation for finished goods supporting final release product for shipping.
• Assists with contract customers’ quality assurance items, including documentation, COAs, CAPAs, and deviation updates as requested.
• Ensure the calibration program remains updated and equipment owners are appropriately notified to remain in compliance
• Maintain Centralized Filing (Quality) and lead the archiving process
• Act as Deviation Coordinator for processing nonconformities, including the issuance of deviation numbers and on time closures.
• Serve as Auditor on the Internal Audit Team. Perform audits, generate reports detailing audit findings and effectively communicate results with Department Owners on corrective and preventive actions, as required.
• Support in activities prior to, during and after external audits and inspections, as required.
• Support in Annual Product Review activities

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• • Bachelor’s Degree or equivalent experience
  • 1-3 years’ relevant experience in a regulated industry.
  • Knowledge of Health Canada Regulations for Drugs and Cosmetics preferred.
  • Experience with Microsoft Word, Excel, Outlook, Teams
  • Experience with electronic document management systems preferred
  • Ability to multitask and prioritize in a dynamic work environment
  • Strong organizational, written/verbal and presentation skills
  • Ability to sit, stand, walk, lift up to 30lbs throughout an 8-hour shift.

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