At Apex International , we pride ourselves on being a high-quality manufacturer of over the counter personal care, and household products. We create collaborative partnerships with customers ranging from global Fortune 100 companies to entrepreneurial start-ups.
We are seeking a Microbiologist I to join our Eden Prairie team. Reporting to the Microbiology Supervisor, this role supports customer success by monitoring products and processes, overseeing material transitions through manufacturing, and ensuring they meet microbial specifications for approval.
Job Duties and Responsibilities :
1.
Audit and test raw materials, R&D formulations, bulk product, finished products and the manufacturing environment against specifications and report findings in a value-added and timely manner.
- Conduct appropriate microbial testing (TPC, Indicator organism, PET, Gram stain, etc)
on select chemical raw materials, all in process and finished product samples to monitor
against limit specifications in a timely manner.
Collect and evaluate production water system samples (USP grade, soft water, DI) toensure compliance to specifications and take action as needed.
Conduct environmental sampling of the facility and equipment (air samples, contact plates, rinse water and surface swabs) at prescribed frequencies and to support qualifications / validation studies.2.
Report results and ensure accurate and timely transition of quarantined raw materials, bulk product and finished products based on testing results.
Communicate results to various departments / customers upon successful completion of testing to coordinate the timely release of product that has passed established specifications for shipment.Immediately report testing results that deviate from specification.Immediately make intervention to any potential non-conformance.Maintain control of "out-of-specification" material by moving it to a holding area electronically.3.
Validate procedures / processes, test methods, and equipment that the lab employs to detect and identify microorganisms to ensure compliance with customer and regulatory guidelines.
Validate microbial recovery test methods (NV, suitability, etc.) to ensure validated methods are used for testing controlled articles (raw materials, bulk, filled product)Qualify various prepared microbial media formulations (growth promotion, media sterility, pH) to ensure suitability for testing controlled articles (raw materials, bulk, and filled product).Calibrate, monitor and maintain test equipment on a daily, weekly and annual basis.4.
Ensures the Microbiology laboratory operates safely & efficiently so customer and regulatory guidelines
are met.
Ensures all documentation pertaining to the Microbiology laboratory is recorded in a timely, detailed, accurate and cGMP compliant manner.Documents the receipt and accessions samples accurately and timely.Records daily testing results on appropriate forms accurately and timely.Maintain microbial cultures used for controls and product validation testing.Maintain multiple quality tracking spreadsheets to facilitate effective investigational efforts.Maintains lab cleanliness in accordance with established housekeeping policies and procedures.5.
Understand and maintain a culture of "lean action" within the department so that we live lean better than any organization.
Implement and maintain standards and processes that eliminate waste throughout the department.Apply and utilize "lean tools" to permanently implement improvements.Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)6.
Perform other work as assigned.
Qualification and Skill Requirements :
Prior Experience :
This position requires 0-2 years of experience in a FDA regulated microbiology Laboratory; prefer a minimum of 6 months experience in a microbiology lab within the pharma, personal care, food, or cosmetics industry. The ability to work with people effectively as required.
Knowledge Requirements :
To be effective, this position requires the ability to multi task, demonstrate a sense of urgency, and the ability to organize. Microbiology knowledge normally acquired through a 4-year college degree in microbiology / biology (or a related science) or equivalent experience is needed.
Technical Competencies :
Knowledge and experience with aeseptic techniques, challenge testing and method validation.Knowledge and some experience with media prep, autoclave, incubators, biological safety cabinet (BSC), etc.Uses processes and technology to improve the quality and efficiency of production; follows processes well.Can follow SOP and test methods; can assist in investigations under direction.Ability to perform testing, review testing data and report on results.Maintain and grow technical knowledge and expertise in Six Sigma, testing, and constant improvement.Is accurate, precise and pays attention to detail.Has working knowledge and experience with MS Office Suite (Word, Excel, Power Point, Outlook).Understands or capable of learning our proprietary Quality system (DaVinci).Able to operate Lab equipment (scales, pH meter, autoclave, flask scrubber, etc).Can read and write at the college level.Can read and follow specifications written in English.Requires math skills including addition, subtraction, multiplication, division and algebra.Work Requirement :
This position may require significant work hours beyond the normal workday based on the demands of the business cycle, customer volume of business, and specific sales efforts underway. It has a moderate to high demand for tight deadlines. This position entails work of a cyclical nature. This position will experience moderate interruption in workflow, starting and stopping for production and customer requirements. Travel is limited.
Physical Requirements :
This position requires :
Continuous (6 or more hours per day) standing and walking.Continuous (6 or more hours per day) talking, teaching, and repetitive motion, hand / wrist movement.Infrequent / Moderate (2 to 4 hours per day) bending, pushing, pulling, climbing stairs, reaching, lifting and grasping.Infrequent / Moderate (2 to 4 hours per day) working at a computer terminal.Occasional (up to 2 hours per day) lifting of up to 50 pounds.Sensory requirements : Good eyesight, normal hearing, and fluent in the English language.Working Conditions :
Will be exposed to various fragrances which at times may be at elevated levels.Benefits :
Annual starting salary range of $60,000 - $65,000Medical, Rx, Dental and vision benefitsCompany paid Short term & Long-term DisabilityCompany paid Life InsuranceOptional Life Insurance for employee, spouse and childrenFlexible Spending Account options for child and health care401(k) Retirement Plan with company matchEmployee Assistance Program