Responsible for representing the department in cross functional meetings
Participate in projects involving Quality Control which include new test methods
Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.
Considered a subject matter expert (SME) for test method(s) executed in the laboratory.
Oversee and/or perform laboratory testing, as well as general laboratory maintenance, including in process and final product release testing and stability testing
Review test data and logbooks, report any deviations to the Supervisor
Ensure timely testing and result reporting
Manage sample shipment and processing with third part labs
Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
Maintain laboratory instrumentation and report any equipment issues to the Supervisor
Assist as needed in test method validation, implementation, and execution.
Assist in preparing for and participating in FDA audits, customer audits, etc.
Complete Out of Specification (OOS) Investigations, Non-conformance Investigations (NCs), Quality Investigations (QIs), and Corrective Action/ Preventative Actions (CAPAs)
Create/Revise Standard Operating Procedures (SOPs)
Complete data entry for trending reports for In-process and Finished Goods Quality Control Testing, as well as Stability Testing
Train and provide guidance to junior team members
Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures
Demonstrate excellent organizational and time management skills.