This position is 5x/week onsite in Rochester, MN.
*Client offers relocation benefit*
Essential Duties:
Responsible for performing and validating analytical methods essential for quality control and release of drug product. Performs environmental monitoring of critical manufacturing areas, thus ensuring that manufacturing processes and products meet quality specifications, under moderate direction of managers and senior team members. The analyst shall maintain quality assurance processes, be responsible for testing products, recording, and analyzing data during product development and manufacturing. The analyst will follow through on set processes and ensure adherence to best production practices and product quality standards, as well as monitors the efficiency and cost-effectiveness of product output. Receives general instructions on routine work and detailed instructions on new projects or assignments.
Duties and Responsibilities:
- Perform and maintain test systems for GMP manufacturing, and responsible for performing assays related to in-production and post-production product quality.
- Performs qualification/validation processes to maintain analytic validity of test methods.
- Monitor aseptic manufacturing suites for contamination.
- Maintain and monitor equipment and instruments, diagnoses and troubleshoots minor issues with laboratory instruments and equipment.
- Monitor production processes for compliance with processes and procedures and participates in non-conformance and complaint investigations, and develops, coordinates and implements corrective and preventive actions.
- Support other manufacturing work areas including supply chain staff in raw material inspections, maintenance of the supply records, supplier management program and recall activities, as needed.
- Assists Quality Assurance staff in collating records for the final batch record review, as needed.
- Continues to develop professional expertise, and apply company policies and procedures to resolve a variety of issues
- Perform and maintain environmental monitoring program
Education Requirements:
- A Bachelor’s degree in a science related field.
- Minimum of 1 years’ experience performing and validating assays and/or working in a manufacturing quality control role.
Required Skills and/or Qualifications:
- Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing and testing is required.
- Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
- Must have demonstrated capacity to write and comprehend complex protocols and reports, programs, and situations.
Weekends or weeknight work is occasionally required depending on the production schedule or
processes needs.
