Quality Systems Specialist

2 days ago

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

Unifin SAS is seeking a highly skilled Quality Systems Specialist to join our team in Rochester, NY. As a key member of our quality team, you will be responsible for managing all site inspections, including regulatory agency inspections, customer audits, and internal self-inspections.

Key Responsibilities:
  • Manage regulatory inspections and customer audits, ensuring the site is "inspection ready" in each area.
  • Coordinate with area managers to ensure adequate preparation for all regulatory inspections, customer, and internal audits.
  • Lead the "Front Room" activities for all customer audits and assist with front room facilitation for regulatory inspections when required.
  • Act as a Subject Matter Expert (SME) for the responsible areas and address inquiries as appropriate.
  • Coordinate the "Back Room" activities during Regulatory Inspections when required.
  • Compose formal responses to audit observations with the assistance of area managers or designees.
  • Ensure follow-up of 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 and perform risk analysis to determine the content and schedule of the annual internal audits.
  • Ensure adherence to the audit schedule, audit reporting, classification of deviations, development of responses, and 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 years of experience in QA in FDA-regulated environments, preferably in a pharmaceutical manufacturing setting.
  • Strong analytical skills, problem-solving ability, and diplomacy required.
  • Ability to influence others toward desired outcomes to mitigate company risk, ensure employee commitment, and drive desired change.
  • Must be comfortable dealing with and resolving conflict.
  • Experience with customer and regulatory audits is highly preferred.
Compensation:

The compensation range for this position is $73,000 - $73,000 per year, depending on qualifications and experience.

Unifin SAS offers a dynamic work environment, a spirit of victory, and a commitment to bringing our values to life with our employees. We propose a high degree of autonomy in the exercise of their profession and encourage their initiatives. We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

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