• Execute the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.
• Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.
• Author and review SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.
• Support data integrity initiatives related to analytical instruments.
• Recommend appropriate user roles and privileges for data integrity (where applicable), write instrument operation instructions and preventative maintenance plans.
• Work with vendors performing maintenance activities on QC analytical instruments.
• Complete periodic reviews of QC instruments and associated instrument control software.
• Identify and follow-up on excursions and deviations and initiate corrective and preventative actions (CAPAs) related to analytical instruments.
• Support stakeholders, including end users, with issues and guidance related to QC analytical instruments.
• Work cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance.
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 3 years of relevant experience OR
• Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience
• 1- 3 years relevant experience, experience in a GMP environment

Preferred Requirements:

• Experience with KNEAT software
• Experience qualifying analytical instruments
• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.