Laboratory Supervisor (Microbiology)

Microbiology Lab Supervisor Duties and Responsibilities
- Supervise daily operation of the Microbiology laboratory.
- Ensure testing requirements for the environmental monitoring program complies to current domestic and international standards.
- Establish and maintain the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC), Compressed Gas Systems and Pharmaceutical Grade Water Systems.
- Supports design and process improvements by providing guidance and testing support in relation to sterilization, bioburden, biocompatibility, cleaning validation and test method validations.
- Support product release testing (i.e. endotoxin)
- Establish and maintain environmental monitoring excursion communication, reporting, investigation, disposition and corrective action process. Requires multi-department communication and approval for coordination of work performed (i.e. Operations, Facilities and QA).
- Maintain compliance of the sterilization program for sterile implantable devices by performing scheduled re-qualification, supplier audits, new product qualifications, challenge and bioburden testing when necessary.
- Must have knowledge of the following 21 CFR 820, ISO 13485, CMDR, and EEC93/42, U.S. and E.U. Pharmacopeia, International Organization for Standardization (ISO) 10993, 14644, 14971 and other Risk guidance standards to create the processes and supporting documentation.
- Works and communicates effectively and professionally with others.
Additional Areas of competence preferred:
- Product and Material Sterilization, Biocompatibility and Cleanroom Microbiology
- Solid understanding of international and domestic medical device GMPs & Quality System Requirements
- Solid understanding of international and domestic environmental monitoring requirements
- Develop and perform test method validations in support of microbiology operations (e.g. Endotoxin Testing) and interpret the results.
Experience/Education
Bachelor's degree with 5+ years of industry experience required
2+ years of informal management and/or team lead experience required
About Aerotek:
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.