Aerotek Laboratory Supervisor in Mesa, Arizona
Aerotek is currently hiring a Laboratory Supervisor for a full time, direct hire opportunity with a Microbiology Laboratory in Mesa, AZ.
Responsible to ensure compliance to domestic and international standards with regards to day to day operation of the Microbiology laboratory, the monitoring of environmental systems (i.e. HVAC/cleanroom, Compressed Air, Water), sterilization of medical devices, biocompatibility testing of materials, supervision and training of laboratory technicians.
Directs the design, development, implementation and maintenance of the bioinformatics function and overall research computing capability. Oversees the computational infrastructure and controls the flow of samples and information for large-scale studies. Provides the organization with both short- and long-term information systems strategies that will help the organization meet its business objectives by developing an informatics database strategy, including the incorporation of large databases from collaborations, strategic alliances and research efforts. Develops and maintains applications systems for the management and analysis of data. Develops novel informatics tools and utilizes emerging web technologies. Provides web-based bioinformatics and access to public and proprietary relational databases. Develops and applies computational tools. Builds and manages a staff of information systems professionals and works in collaboration with drug discovery project teams. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Essential Duties and Responsibilities:
• Supervise daily operation of the Microbiology laboratory including 4 laboratory technicians.
• 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 possible competence:
• 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.
• This position assumes and performs other duties as assigned.
• A Bachelor’s degree with 5-8 years of industry experience; 2+ years of formal or informal management/ team lead experience
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.