Temporary Microbiology Study Director - New Brighton, United States - TUV SUD America

Description

Temporary Microbiology Study Director - Medical Device

Overview:

Looking for an experienced microbiology study director, for temporary hire, who enjoys working in a fast-paced environment. The contract term will be approximately 5 months. The candidate should be able to effectively study direct and lead laboratory-based microbiology studies and testing, evaluating a variety of medical devices. Laboratory Test Methods include those for Sterility Assurance (i.e., bioburden, sterility, endotoxin testing, etc.) and Cleaning, Disinfection, and Sterilization Validation Studies for Reusable Devices. The ideal candidate has a strong and exhaustive laboratory background, as well as excellent client service and project management skills.

Responsibilities:

Performs Study Director functions as outlined by FDA Good Laboratory Practices (21 CFR Part 58) for GLP Studies, as well as serves as a technical leader in ensuring proper execution of additional microbiology testing (testing of bioburden, sterility, endotoxin, biological indicators, etc.)

Collaborate with technical advisors, sales, and microbiology team members in establishing test recommendations according to microbiology industry guidelines/standards including, but not limited to: ISO 11135, ANSI/AAMI ST72, USP , USP , ISO , USP , USP, ISO , ISO , ISO , ANSI/AAMI/ISO 17665, ANSI/AAMI ST98, ANSI/AAMI ST79, ANSI/AAMI TIR 12, ASTM F3438

Provides scientific support and guidance to clients and other scientific staff in the study design, conduct and interpretation of test records to ensure technical integrity of studies

Generates protocols, protocol amendments, custom test records, non-conforming work, and reports in adherence to GLP and/or test method regulations

Assures adherence to protocol, protocol amendments, and company SOPs throughout the conduct of studies

Assures that all data including unanticipated responses and nonconforming work are accurately analyzed, recorded, organized, and communicated clearly to the client

Utilize strong project management skills to efficiently manage multiple studies and clients

Collaborate and clearly communicate with cross-functional teams and clients to ensure client's needs are met

Report studies and testing in a timely manner in accordance with expected performance metrics

Provides leadership and guidance regarding testing/study execution to laboratory analysts and the laboratory support team, including scientific project managers, test facility management, laboratory coordinators, and the quality assurance unit

Assist and lead in quality system compliance, laboratory support, and test method documentation

Provide support and lead in Laboratory Method development, by assisting with document revisions and providing technical review of documents.

Lead and assist in planning execution of equipment/instrument qualification and calibrations

Qualifications:

Minimum BS/BA in microbiology or related field

Minimum of 4 years applicable of experience in a laboratory environment. Preferred experience with medical device reprocessing validations, sterility testing, sterilization (EO, Steam, Dry Heat, Gamma), bioburden, and endotoxin testing

At least one year as a study director in the medical device industry

Strong working knowledge of industry regulations (ISO 10993 series of standards, ISO 17025, ISO 13485, ISO 11135, ISO , ISO , ANSI/AAMI ST79, ANSI/AAMI ST98, ASTM F3438, GMP and GLPs) supporting a medical device environment

Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP)

Ability to organize and track multiple projects in a detail-oriented and self-directed manner

Maintain accurate schedule and follow-up efficiently

Strong organizational skills required

Advanced problem-solving skills and strict attention to detail

Strong technical writing and oral communication skills

Exhibit excellent communication skills and be a proactive, collaborative team player

Self-starter with a positive and motivated attitude

Equal Opportunity Employer - Disability and Veteran

TUV SUD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following:

Contact

TUV SUD Recruiting

ShareAbout TUV SUD as Employer

At TUV SUD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TUV SUD.

Established more than 150 years ago in Germany, TUV SUD is a leading global provider of technical services with more than highly skilled employees across 1,000 offices worldwide. For over 30 years, throughout 33 locations, it is TUV SUD America's priority to create a safer future. To protect people, property and the environment from technology-related risks; we drive consumer protection, digital transformation, sustainable development, and urbanization.

Find out more about TUV SUD

TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.