Quality Assurance Specialist

2 days ago

Rochester, New York, United States Unifin SAS Full time
Job Title: Quality Systems Specialist

At Unifin SAS, we are seeking a highly skilled Quality Systems Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the site's Pharmaceutical Quality System is compliant with regulatory requirements and industry standards.

Key Responsibilities:
  • Manage regulatory inspections and customer audits
  • Coordinate with area managers to ensure the site is "inspection ready" in each of the areas by monitoring the site during regular site visits
  • Ensure adequate preparation for all regulatory inspections, customer, and internal audits to include documentation and site personnel
  • Lead the "Front Room" activities for all customer audits and assist with front room facilitation for regulatory inspections when required
  • Act as SME for the responsible areas as described in the job summary and address inquiries as appropriate
  • Coordinate the "Back Room" activities during Regulatory Inspections when required
  • Compose the formal responses to the audit observations with the assistance of area managers or designees
  • Ensure follow-up of the corrective action plans initiated after customer audits and regulatory inspections
  • Document all inspection activities within the TrackWise system according to required timelines
  • Facilitate the self-inspections management process
  • Perform risk analysis to determine the content and schedule of the annual internal audits
  • Formalize the audit schedule ensuring that all six systems in the inspection model are considered including quality, production, facilities and equipment, laboratory controls, materials, and packaging/ labeling
  • Ensure adherence to the audit schedule, audit reporting, classification of deviations, development of responses and the implementation of actions
  • Provide continuous training for the internal audit team and facilitate professional training when necessary
Requirements:
  • Bachelor's Degree in Life Sciences or related field
  • Minimum 3-5 year experience in QA in FDA regulated environment, preferably in a pharmaceutical manufacturing setting
  • Strong analytical skills and diplomacy required
  • Ability to influence others toward desired outcomes to mitigate company risk, ensure employee commitment, and drive desired change
  • Experience with customer and regulatory audits
Compensation:

The compensation range for this position is $73,000.00 - $81,000.00 USD per year.

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.*

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