ProMed Molded Products, Inc.-posted 30 days ago
Full-time • Entry Level
Maple Grove, MN
101-250 employees
Miscellaneous Manufacturing

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people's lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best. ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world. Working as one to help many. POSITION SUMMARY The mission of this role is to safeguard product quality and regulatory compliance by executing rigorous data validation protocols that ensure all analytical testing results meet GMP standards before product release. This position serves as a critical quality gate, preventing costly regulatory violations and product recalls through comprehensive technical documentation review and data integrity assessments. By systematically identifying and resolving data discrepancies and anomalies, the role protects the organization's reputation and market access while maintaining the highest standards of scientific rigor. The position directly supports manufacturing operations and regulatory submissions by ensuring all data packages meet stringent compliance requirements, ultimately enabling successful product commercialization and sustained market presence. The Data Reviewer ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed.

  • Review analytical testing data for accuracy and completeness to ensure all scientific results meet GMP compliance standards and regulatory requirements, enabling reliable product release decisions and successful regulatory submissions.
  • Validate instrument calibration status prior to accepting test results.
  • Verify that executed analytical tests match their corresponding written test methods to ensure procedural compliance and data integrity.
  • Evaluate chromatographic data quality by examining peak resolution, baseline stability, and system suitability parameters to ensure analytical methods meet established performance criteria.
  • Examine analytical data packages systematically to verify completeness of testing protocols, accuracy of results, and adherence to GMP standards
  • Ensure compliance with Good Manufacturing Practice regulations throughout all data review activities, maintaining consistent adherence to quality standards.
  • Apply current FDA guidance documents and company policies and procedures to data review processes.
  • Demonstrate proficiency in quality system procedures and work instructions.
  • Complete continuing education on evolving GMP regulations.
  • Identify and document data discrepancies, anomalies, and deviations in analytical results, ensuring comprehensive investigation and resolution of all quality issues.
  • Review deviation reports to assess completeness and evaluate quality standards compliance
  • Coordinate with laboratory personnel to clarify questionable data points.
  • Execute data integrity assessments across analytical datasets, identifying potential compliance risks and ensuring adherence to data governance standards.
  • Audit electronic records for completeness and authenticity markers.
  • Review audit trails for unauthorized modifications or deletions.
  • A bachelor's degree in Chemistry or equivalent work experience
  • A basic familiarity with Waters Empower
  • At least one previous role involving work in an analytical laboratory
  • 401k with company match
  • Profit Sharing program
  • Medical Insurance
  • Health Savings Account/Flexible Spending Account
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Short, and Long-Term Disability Insurance
  • Critical Illness, Accident, and Identity Theft Protection
  • Pet Insurance
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