The Associate Scientist, Quality Control – Reagent Manufacturing will be an integral part of a operations team that performs raw material, finished goods subassembly qualification testing and data-analysis for reagents for the Harmony test. The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO13485 and soon to be cGMP manufacturing environment. The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Standard Operating Procedures (SOP).
Perform inspection and testing of raw materials and in-process finished goods subassemblies right first time in a compliant manner
Conduct data analysis of raw material and in-process finished goods subassemblies test results
Review QC records and generate Certificate of Analysis for finished products
Formulate reagents with high complexity for raw material testing
Document test results, complete batch records, document observations and generate reports for raw material and in-process finished goods subassembly qualification testing
Responsible for generating compliant QC documentation as part of the Device Master Record required for releasing items into inventory from the raw material to the final kit assembly level
Maintain records and QC laboratory environment to comply with cGMP, SOP and regulatory requirements.
Serve as a contact for other departments regarding QC related activities, quality issues, nonconformance investigations, and root cause analysis
Provide input for brainstorming activities, support approaches for problem-solving, trouble-shooting and data analysis related to QC failures
Provide training to quality control team members
Assist in reagent and lab supply inventory management in order to support multiple QC laboratories
Assist in performing routine maintenance of laboratory equipment
- Support 5S efforts to streamline overall operations and improve efficiency
- Assist with troubleshooting of failures, work with others to implement solutions.
- Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture in which no one gets hurt.
- May assist in regular laboratory environment monitoring tests
- May assist in transferring processes from development to QC
- May assist in testing raw materials for reliability and stability
- May assist in identifying quality gaps and support continuous improvement / operational excellence initiatives.
- May assist in process monitoring and trending across all shifts.
- May collect, interpret and communicate process metrics; utilize metrics to recommend improvements.
- May assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment
- May assist in the development and implementation of raw material testing processes, physical quality specification tests and documentation
- May assist in reagent manufacturing activities unrelated to QC activities