Description
\t\t\t\t\tShe is looking for the microbiology role, the day to day, testing they do is minimal. They do endotoxin and bioburden, environmental monitoring. They are ISO 8 clean room. They do touch plates (plate with auger that they touch on various surfaces and incubating it. Will also do monitoring. Will also help perform quality analysis on the water systems. Everything else will be assisting the quality or QC department. Will cross train in various sides so they can help out when they get swamped. This could involve verifications, quality analysis on the lab, what can we update, calibrations, talking to vendors. People skills to call and talk to vendors to help work through supply chain problems.Attention to detail is critical. The difference between micro-liters can mess up a test that can take upwards of 5 hours.Supports all activities related to microbiological assessment of products and the manufacturing environment. Advise Quality Assurance, Manufacturing and R&D departments on matters related to product sterilization and microbial assessment. Evaluate the operation of Manufacturing and Quality Assurance activities in relation to sterilization compliance to quality standards and regulations and recommend where corrections or improvements are indicated. Supports root cause analysis for nonconformity and/or out of specification events. Provide direct support to Quality Assurance personnel regarding operation of the department and Quality System.Quality Testing•\tPerform Endotoxin and Bioburden testing per established procedures. •\tPerform Environmental Monitoring (EM) of the Cleanrooms as required. •\tPerform quality analysis of the water systems for the manufacturing sites as required.Documentation•\tPerform quality review for microbiological testing/EM monitoring data.•\tCoordinate and maintain associated databases for all microbiological data and provide support to other departments as required.•\tMonitor microbiological trends in their respective areas and responds appropriately.•\tWrite, revise and review related Standard Operating Procedures (SOPs) and Department related Protocols.•\tPerform root cause analysis for microbial excursions and other microbiology investigations.•\tWrite and review investigations of microbial excursions and other microbiology investigations.•\tMonitor the manufacturing and quality assurance activities associated with the sterilization of Merz Aesthetics Medical products.Validation Support•\tAssist with sterilization product and process validations as required to insure product quality and Quality System requirements are met.Regulatory Support•\tMaintain a high level of expertise in current regulatory requirements, including FDA Quality System Regulations, and ISO standards. •\tParticipate in audits and as part of cross-functional teams with other functional areas and facilities as an SME (Subject Matter Expert). Manufacturing Support•\tSupport sterilization, product, process, environmental and cleaning validations as required to insure product quality and Quality System requirements are met.This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time. Remote work Eligibility - No – role does not allow for remote work.Work Schedule: 7AM-3:30PM M-FPhysical Demands/Environment Clean room work is required. Lifting of light (less than 15 pounds) objects.
\t\t\t\t\tSkills
\t\t\t\t\taseptic technique, plating, microbiology
\t\t\t\t\tTop Skills Details
\t\t\t\t\taseptic technique,plating,microbiology
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tEducation and/or Experience (years)BS in Microbiology, Biology, Physical Science or equivalent experience required.1-2 years' experience in Quality Laboratory, preferred.GLP/GMP experience is preferred.4.
\t\t\t\t\tExperience Level
\t\t\t\t\tEntry Level
Pay and Benefits
The pay range for this position is $21.00 - $23.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Sturtevant,WI.
Application Deadline
This position is anticipated to close on Aug 18, 2025.
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