Compliance Specialist II


Published
August 9, 2022
Job Type
Salary Option
Based on Experience
Street Address
500 Linden Oaks Suite 140
City
Rochester, NY

Description

AP Professionals has partnered with a manufacturing company in search of a Compliance Specialist. This role is highly interactive with customers and all levels of management to ensure the full investigation and resolution of product complaints. The ideal candidate will be detail oriented, customer focused, and be comfortable making decisions. Must have a Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related field.

This is a full time, direct hire opportunity

This opportunity is not eligible for Visa sponsorship

Responsibilities

  • Reporting to the Quality Assurance Manager
  • Manage the processing and reporting of product complaints
  • Conduct investigations in accordance with company procedures
  • Ensure complaints are resolved
  • Serve as a contact to represent the Quality Assurance department
  • Approve GMP documents
  • Ensure compliance with the product release system
  • Work with operations and other groups to investigate and document deviations
  • Review protocols, reports and change controls
  • Provide QA guidance to others in the organization
  • Interaction with customers regarding deviations, Change Controls and CAPAs.
  • Support customer and agency audits as needed

Education

  • BS in a scientific field

Experience

  • 7+ years of experience in an FDA regulated environment
  • Quality assurance or compliance experience in a manufacturing or similar environment
  • Audit experience/training
  • Previous experience in a similar QA role
  • Lab background/experience

Knowledge, Skills, Abilities, and Other Characteristics

  • Knowledge of completing audits and regulatory inspections
  • Familiarity with ERP systems
  • Familiarity with Microsoft Office programs
  • Must have the ability to analyze, interpret, generate and communicate data statistically
Apply
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