Microbiologist Associate

Position: Microbiologist Associate I
Location: Franksville

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Microbiologist Associate I

Job Description:

Job Title: Microbiologist Associate I

Job Type: Contract

Job Location: Franksville, WI, 53126

Work Schedule: On-site

Starting rate: $23, Based on experience

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

• Perform Endotoxin and Bioburden testing per established procedures.

• Perform Environmental Monitoring (EM) of the Clean rooms as required.

• Perform quality analysis of the water systems for the manufacturing sites as required.
Documentation

• Perform quality review for microbiological testing/EM monitoring data.

• Coordinate and maintain associated databases for all microbiological data and provide support to other departments as required.

• Monitor microbiological trends in their respective areas and responds appropriately.

• Write, revise and review related Standard Operating Procedures (SOPs) and Department related Protocols.

• Perform root cause analysis for microbial excursions and other microbiology investigations.

• Write and review investigations of microbial excursions and other microbiology investigations.

• Monitor the manufacturing and quality assurance activities associated with the sterilization of Aesthetics Medical products.
Validation Support

• Assist with sterilization product and process validations as required to insure product quality and Quality System requirements are met.
Regulatory Support

• Maintain a high level of expertise in current regulatory requirements, including FDA Quality System Regulations, and ISO standards.

• Participate in audits and as part of cross-functional teams with other functional areas and facilities as an SME (Subject Matter Expert).
Manufacturing Support

• Support 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-F

Education and/or Experience (years)
1. BS in Microbiology, Biology, Physical Science or equivalent experience required.
2. 1-2 years' experience in Quality Laboratory, preferred.
3. GLP/GMP experience is preferred.
4. Pharmaceutical experience is preferred.

Physical Demands/Environment
Clean room work is required.
Lifting of light (less than 15 pounds) objects.

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Vidit Saini ( () for more details.