Pace Analytical Life Sciences (PLS) is an industry leading contract lab supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, and Life Sciences industry. Since our formation in 2006 we have grown at a rate of over 15% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a range of clients worldwide. We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service.
This position as a Associate Scientist II role is permanent, full-time role working 40 hours a week. The Associate Scientist II role is working at Pace Analytical Life Sciences, LLC in Oakdale, MN. The candidate that is hired for this role will be trained in Monday through Friday day shift in about 3-4 months will be required to work Monday through Friday on second shift from 3:00pm – 11:00pm.
Our Associate Scientist II’s have the ability to perform tasks related to test areas, projects, or quality programs with a high-level involvement in the day-to-day testing and quality activities. This is a position where the individual is beginning to work independently and exhibits a greater understanding of the theories and concepts beyond the routine sample analysis and the quality system management. In the Associate Scientist II role you will be completing endotoxin, sterility, environmental monitoring, antimicrobial efficacy testing, as well as general lab cleanliness.
Essential Functions include the following, but not limited to:
· Primary responsibility is the routine activities associated with performing tests, test area, or quality systems, including preparing samples, running instruments, and/or administering quality programs. Including but not limited to:
- Collection of environmental monitoring samples at client facilities in manufacturing areas to ensure an appropriately controlled environment meeting regulatory expectations and industry standards
- Routine environmental monitoring (viable and non-viable particulates)
- Water Analysis (Total Viable Count, absence of coliforms, Total Organic Carbon and Conductivity)
- Conduct Bacterial Endotoxin testing of water samples and product using Kinetic Turbidimetric Methods
- Perform Bioburden testing in support of sterilization validation and quarter dose audits
- Raw material and finish product release testing in accordance with compendia methods: <61> Microbial Limit Test, <51> AET Test, <71> Sterility Test
· Possess strong technical, quality, and safety understanding to provide support and training to staff members and clients
· Assist with method development, transfers, validations in accordance with GMP guidelines
· Assist with data system management
· Author and review technical or quality methods, procedures, protocols, and reports in accordance with GDP
· Assists with laboratory projects from set-up through data interpretation and reporting
· Performs both routine and non-routine assignments, utilizing a wide array of instrumentation
· Assists with training staff on methods, instruments, and quality principals
· Assist in equipment and facility maintenance; investigates and facilitates the solving of any equipment/facility problems
· Assist with client communication to provide updates and report any issues as necessary
· Strong time management abilities to ensure project deadlines are met
· A champion of cooperation and teamwork within the group and the company
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· M.S. or B.S. in microbiology (or similar) with at least 3 years of relevant industry experience
· Valid driver’s license
· Experience using aseptic technique, autoclaves, gram staining
· Experience testing air, personnel, and surfaces for active and non-active particulates
· Clean room and manufacturing environment experience
· Assist in the design and implement method development and validation studies.
· Ability to multi-task and interact with multiple groups in a team-oriented environment,
· Plan, implement, review continuous improvements, assist in the design and implement method development and validation studies.
· The ability to read and understand relevant scientific literature, procedures, and protocols.
· Outstanding written and oral communication skills as well as polished and persuasive presentation skills.
· Flexibility and outstanding time management skills to provide the full range of pharmaceutical support (including project representation) across multiple projects.
· Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
· Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public both verbally and in writing.
· Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Performing very complex to specialized professional-level microbiology duties in a variety of assigned areas.
• Overseeing and administering broad and varied microbiology functions.
• Training others in policies and procedures related to the work.
• Serving as a team member and the development and management of projects.
• Operating in a both a team and individual contributor environment.
• Interpreting, applying and explaining applicable laws, codes and regulations.
• Preparing very complex to specialized functionals reports, correspondence and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion and prudence in working with those contacted in the course of the work.
• Performing effective oral presentations to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.
This role is full-time, permanent role working Monday through Friday from 3:00pm to 11:30pm. 40 hours a week.