QC Compliance Specialist

Company: Cambrex
Location: Charles City
Posted on: August 6, 2022

Job Description:

Overview
Reporting to Quality Control Manager, the Quality Control Compliance Specialist will author investigations, assist with employee training, review release testing, and author controlled documents. Interaction with multiple areas of the site will be inherent in this position.
Responsibilities

• Contribute to the compliant operation of Quality Control by attending project team meetings as the QC representative and serve as a client liaison.
• Write, revise, review, or approve SOPs, protocols, analytical methods, reports, and specifications.
• Provide consultation on quality and compliance topics in areas of expertise and assist with quality improvement initiatives.
• Identify discrepancies, author out of specification and deviation investigations within TrackWise, and implement associated CAPAs. Lead Root Cause Analysis exercises within the department or cross-functionally if applicable.
• Drive coworker ownership of TrackWise items through development and presentation of training materials to improve quality of investigations and/or reports based on internal and external feedback.
• Develop and track metrics for open TrackWise items including overdue items, time to close, etc. Accountable for working with area Managers and Supervisors to achieve site and regulatory goals/commitments.
• Actively participate and contribute to Operational Excellence objectives. Maintain and/or develop additional metrics and other tools to measure QC Compliance. Understand departmental KPIs and their impact on site goals.
• Assess method lifecycle updates based on instrumentation or compendia changes.
  All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
  Qualifications
  
  • BS in Chemistry or a related field.
  • cGMP knowledge required
  • Minimum 3 or more years of experience within quality control.
  • Experience with analytical development and validation preferred.
  • Proficiency in a windows-based environment including word processing, spreadsheet, and database programs
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Keywords: Cambrex, Rochester , QC Compliance Specialist, Other , Charles City, Minnesota