Associate Scientist I - Microbiology (entry level)
Pace Analytical Life Sciences (PLS) is an industry-leading commercial contract laboratory providing chemistry and microbiology testing services to the Pharmaceutical, Biopharmaceutical, and Medical Device industries. Since our formation in 2006 we have grown at a rate over 15% per year and we have established ourselves as one of the top ten contract laboratories within the United States. We are providing cGMP-compliant testing services to a wide range of clients worldwide. We attribute our sustained growth to our exceptional culture of client service and robust service offerings.
Summary:
Responsible for providing or overseeing the analysis, our Associate Scientist I'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.
This is an entry level lab role, full-time, permanent position at Pace Analytical Life Sciences, LLC in Oakdale, MN working in the Microbiology department. This role will start working Monday through Friday for the first 3-4 months and then transition to Tuesday through Saturday scheduled once trained in.
Essential Functions:
This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.
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
- Cleans, maintains, prepares and calibrates equipment, samples, and related areas.
- Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed.
- Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
- Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
Qualifications:
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.
Education and Experience:
Bachelor's degree in biology or microbiology, or a closely related field; OR an equivalent combination of education, training and experience. Valid driver's license is required.
Required Knowledge:
- Fundamental principles, practices and techniques of microbiology.
- Standard understanding of the administration and oversight of microbiology programs, policies and procedures.
- Fundamental methods to resolve microbiology problems, questions and concerns.
- Standard understanding of applicable microbiology laws, codes and regulations.
- Understanding of standard testing tools, instruments and calibration.
- Computer applications and systems related to the work.
- Principles and practices to serving as an effective project team member.
- Methods to communicate with staff, coworkers, and customers to ensure safe, effective and appropriate operations.
- Correct business English, including spelling, grammar and punctuation.
Required Skills:
- Performing fundamental professional-level microbiology duties in a variety of assigned areas.
- Knowledge and experience using aseptic technique, autoclaves, gram staining
- Overseeing and administering standard 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 fundamental 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.
Physical/Mental Requirements:
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.
Working Environment:
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.
OFCCP Statement - Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.
The Associate Scientist I role is Tuesday through Saturday working between the hours of 8:00am and 5:00pm.
Training will be Monday through Friday for about three to four months from date of hire. Then transition to Tuesday through Saturday schedule to meet business and client needs once training is completed. 8:00am to 5:00pm - 40 hours a week