Quality Control Analyst – Rochester, MN
Responsible for executing and validating analytical methods that are vital for quality control and the release of drug products. Conducts environmental monitoring in key manufacturing areas to ensure compliance with quality specifications, working under the moderate supervision of managers and senior team members. The analyst will maintain quality assurance processes, test products, and record and analyze data during the stages of product development and manufacturing. They will follow established protocols to ensure adherence to production best practices and quality standards while also assessing the efficiency and cost-effectiveness of product output. Receives general guidance for routine tasks and detailed instructions for new projects or assignments.
Details:

• Direct Hire with Benefits
  

• Full-time, first shift
  

• Salary depending on experience level, starting at $65,000/year

Responsibilities:

• Maintain and operate test systems for GMP manufacturing, focusing on assays related to both in-production and post-production product quality.
  

• Perform qualification and validation processes to ensure the analytical validity of testing methods.
  

• Monitor aseptic manufacturing suites for potential contamination.
  

• Oversee the upkeep and monitoring of equipment and instruments, diagnosing and resolving minor issues with laboratory tools.
  

• Ensure production processes comply with established procedures, participate in non-conformance and complaint investigations, and implement corrective and preventive actions.
  

• Assist other manufacturing areas by supporting supply chain staff in raw material inspections, maintaining supply records, managing supplier programs, and participating in recall activities as needed.
  

• Aid Quality Assurance staff in compiling records for final batch record reviews when necessary.
  

• Continue to develop professional expertise, applying company policies and procedures to tackle various issues.
  

• Manage and maintain the environmental monitoring program

Requirements:

• A Bachelor’s degree in a science related field.
  

• 1+ years of experience working in a GMP quality control manufacturing role.
  

• Additional experience Good Laboratory Practices (GLP) or ISO, etc. preferred.
  

• Exceptional communication skills.
  

• Detail-oriented and able to work independently with minimal direction, while exercising initiative and sound judgment.
  

• Strong analytic skills coupled with critical thinking skills are essential in this role.
  

• Ability to write and comprehend complex protocols, programs, and reports.
  

• Strong quality judgment while under pressure, flexible priorities, and tight deadlines.
  

• Prolonged periods of sitting at a desk and working on a computer.

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