QC Compliance Specialist
Location: Charles City
Posted on: August 6, 2022
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.
- 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
- 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
- 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
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.
- BS in Chemistry or a related field.
- cGMP knowledge required
- Minimum 3 or more years of experience within quality
- Experience with analytical development and validation
- Proficiency in a windows-based environment including word
processing, spreadsheet, and database programs
Keywords: Cambrex, Rochester , QC Compliance Specialist, Other , Charles City, Minnesota
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