Perform a variety of microbiological testing from routine to advanced procedures including research and development work following approved protocols, work instructions, and regulatory agency guidelines for the medical device and pharmaceutical industries. Analyze data, write, review, and approve technical reports and records, interact with clients.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Management of study timelines
Generates, reviews, and approves technical, GMP and GLP protocols and reports
Reviews and approves test data and interpretation of results as needed
Generates and approves letters of opinion, or other measures of medical device equivalence
Generates, reviews, and approves method validations or modifications to existing methods
May perform routine and non-routine testing as needed
Responsibility for department equipment and processes, including equipment qualifications
Reviews industry standards and regulations, implements changes as needed
Development of department staff and mentors junior staff members
All other tasks as assigned by management
Directly supervise and/or provides leadership to other Microbiology Department staff members. Responsibilities may include interviewing, training employees, planning, assigning, and directing work and conducting performance evaluations.Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION, EXPERTISE and EXPERIENCE
Associate degree in biological science with a minimum of 4 years of relevant experience or an equivalent combination of education and experience. Ability to read and understand sterilization procedures, conduct as well as supervise laboratory testing and operate laboratory equipment.
Proficiency with Microsoft Word and Excel required.
Ability to read, analyze, and interpret technical procedures. Ability to write reports, correspondence, and procedures. Ability to effectively present information and respond to questions. Ability to interpret results and communications in writing. Must demonstrate good scientific terminology.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent. Normal procedures require ability to determine weight measurements and proportions, prepare dilutions. Must know the metric system.
Must be able to schedule tasks, organize time, and plan ahead. Must present a logical approach to conducting scientific experiments, problem solving, and decision making.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee may regularly stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear. The employee may frequently sit for extended periods of time while typing and reading from a computer monitor.
The employee may be required to lift and/or move up to 30 pounds. Specific vision abilities required by this job include close, color, depth perception distance and peripheral vision and the ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Combination of Office and Laboratory settings with the potential for regular exposure to fumes or airborne particles, toxic or caustic chemicals, or biological hazards. Moderate noise levels exist.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
For more information, or to apply, please contact us at .
Loading some great jobs for you...