The ideal candidate will possess a minimum of one (1) years' experience performing Equipment Sterility Testing, ideally in a healthcare or pharmaceutical environment. Will also consider applicants with sterility testing experience in manufacturing, food or vitamin industries. Successful candidates will conduct analytical laboratory testing in the biological and chemical areas, investigate excursions, and participate in test method development and validations. Must be able operate in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.

Responsibilities: Essential Duties

• Perform QC Analytical Laboratory testing related to organization's components, materials and products in accordance with company policies and procedures. Document results and report the identification of Out of Specification (OOS) results and product nonconformances.
• Perform testing as required per the applicable area assigned:
• Microbiology: Conduct sterility testing and environmental monitoring
• Cytotoxicity: Perform Cytotoxicity testing
• LAL: Perform bacterial endotoxin testing
• Chemistry: Perform chemistry testing (ex: EtO residual testing, corrosion and turbidity, solvent, industrial hygiene, IR and heavy metal testing)
• Execute activities required for the completion of laboratory test methods including maintenance of laboratory equipment, cleaning and servicing, preparation and storage of equipment, materials and labware, and maintenance of laboratory supplies inventory.
• Execute validations for QC Analytical Laboratory equipment and test methods and document results.
• Assist in the development and maintenance of department procedures and test methods.
• Adhere to all safety, clean room and laboratory policies and procedures.

• Track and monitor key process indicators related to the QC Analytical Laboratory and report on trends to management.

• Work with other departments on known or emerging issues to quickly resolve quality problems.
• Ensure personal training in accordance with department training matrix.
• Ensure operations within approved department budget.
• Performs other related duties as required by management.

Responsibilities: Other Duties