Microbiologist

VIVOS HOLDINGS • Mooresville, IN

4d • $105 - $120 • Onsite

About The Position

The Microbiologist is a key strategic role that is responsible for the accurate analysis of incoming raw materials, bulk liquids and finished products utilizing Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak’s Test Methods (NPTMs), Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). Assures that released raw materials, bulk liquids and finished products have met the required specification criteria prior to release. Perform sterility tests. Perform Environmental Monitoring (EM) for the facility. Maintain accurate, complete and traceable documentation related to analysis and disposition. Review documentation to ensure adherence to internal and external requirements. Support Internal and External Audits and Inspections where appropriate.

Requirements

• You must be a champion of Nice-Pak; we protect our people, products, and customers.
• To embrace and embody our Core Values: Safety, Teamwork, Integrity, and Excellence.
• 6 months of direct experience in a Nice-Pak laboratory or at least 1 year of experience in an academic or industry laboratory environment, preferably in a manufacturing environment regulated by 21 CFR 210-211.
• Bachelor’s degree in biology and/or Microbiology, or other science related bachelor’s degree, preferred, or equivalent work experience.
• A minimum of 2 years of higher education in a science-based academic program with 1+ years of science-based work experience.
• Microbiology/Analytical methods and theories with the ability to incorporate these into daily communications and problem solving.
• Able to follow test methodology accurately and precisely.
• Proficiency in MS Excel, Word, Access, LIMS, etc.
• Strong leadership skills and problem-solving skills with the ability to conduct root cause analysis for out-of-specification results.
• Effectively plan and demonstrate organizational skills, attention to detail, time management, and accuracy.
• Strong communication and interpersonal skills, with the ability to interact effectively with employees at all levels.
• Ability to work in a team environment, sharing information learned with other team members.

Responsibilities

• Performance of required Microbial testing according to NPTMs, SOPs and WIs on raw materials, bulk liquids, water, environmental and finished products.
• Perform non-routine microbial testing such as investigations regarding environmental and water samples.
• Ensure that all results are accurately recorded in appropriate laboratory notebooks and other designated forms according to GLP’s.
• Record data accurately into LIMS system.
• Provide production and other plant areas with technical expertise and analytical skills to facilitate problem solving and root cause analysis.
• Order laboratory microbial supplies and monitor inventory.
• Develop and perform validation studies when required.
• Recommend equipment purchases and upgrades.
• Support and perform method transfers and validations.
• Present lab results for monthly meetings.
• Prepare / revise laboratory procedures (WIs, methods, SOPs, etc.) when required.
• Review laboratory notebooks for 21CFR section 11 compliance.
• Handle special projects and assign them when required.
• Furnish reports, as necessary, to the QA/QC manager/supervisor, quality director, or designee.
• Conduct Quality team problem solving and root cause analysis.
• Assist with site cost savings goals as they relate to Quality.
• Develop and implement short- and long-range goals and plans for continuous improvement.
• Participate in Internal and External Audits and Inspections where appropriate.

Benefits

• Great benefits that start when you do, including 401(k) match, and vision, medical and dental coverage.
• We also offer tuition reimbursement, among other benefits.
• Excellent pay, commensurate with experience, with additional bonus opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level