Apex International Hiring Microbiologist
Job Title: Microbiologist II
Location: Eden Prairie, MN, USA
Job Purpose: To contribute to the success of our customers by monitoring products and processes and controlling the transition of material throughout the manufacturing process that meet microbial specifications for approval.
Job Duties and Responsibilities:
- 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) to ensure compliance to specifications and take action as needed.
- Conduct environmental sampling of the plant environment and equipment (air samples, contact plates, rinse water & surface swabs) at prescribed frequencies and to support/validation studies.
- 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 nonconformance.
Maintain control of “out-of-specification” material by moving it to a holding area electronically. - 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, and 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.
Ensures the Microbiology laboratory operates safely and 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.
- Participates in internal audits.
- 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)
- Perform other work as assigned.
Qualification and Skill Requirements:
Prior Experience:
This position requires 2+ years experience in a FDA regulated microbiology laboratory in the pharmaceutical, personal care, food, or cosmetics industry. The ability to work with people effectively is 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. Demonstrates understanding of relevant CFR and ensures laboratory compliance with current regulatory requirements (e.g. USP) and begins exposure with regulatory requirement to test products and formulas.
Technical Competencies:
- Demonstrated knowledge and experience with aeseptic techniques, challenge testing and method validation. Ability to troubleshoot challenge testing and method issues.
Some experience with environmental monitoring required. - Demonstrated proficiency with aeseptic techniques, media prep, autoclave, incubators, biological safety cabinet (BSC), and advanced testing techniques.
- Uses processes and technology to improve the quality and efficiency of production; follows standard processes well.
- Can lead micro investigations as well as author and review technical reports
- Demonstrated ability to perform cGMP testing, review testing data, and report on results; can train others on same.
- Demonstrated experience leading advanced testing in lab.
- Demonstrates adaptability to achieve on time delivery of test results.
- Acts as a training mentor.
- 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).
- Demonstrated proficiency with LIMS (DaVinci) and MRP (Alliance) systems.
- 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:
Indoors, seasonally hot and humid.
Will be exposed to various fragrances which at times may be at elevated levels.
Apex International Hiring Microbiologist, Apex International Hiring Microbiologist
