Microbiology Associate I

Merz North America•Franksville, WI

About The Position

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. A Brief Overview This role is responsible for executing daily activities in the Microbiology Laboratory including supporting all activities related to microbiological assessment of Merz products, the Merz DI water systems, and the manufacturing environments. 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 with quality standards and regulations and recommend where corrections or improvements are indicated. Supports root cause analysis for nonconformity and/or out of specification (OOS) events. Provide direct support to Quality Assurance personnel regarding the operation of the department and Quality System.

Requirements

Bachelor of Science (B.S.). Bachelor of Arts (B.A.) in Microbiology, Biology, Physical Science or related field.
Strong technical and general problem solving skills.
Strong aseptic technique and understanding of microbiology.
Training of personnel.
Familiar with ISO 9000/ISO 13485 Quality System Standards, ISO 14644 Cleanrooms and Associated Controlled Environments, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
Familiarity with ISO standards, USP, EP, and JP.
Knowledge of activities required to test product and monitor the manufacturing environment for microbiological character.
Ability to work with company staff and communicate effectively throughout the organization is essential.
Excellent written and oral communication skills.
This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Nice To Haves

Experience in Quality Laboratory.
GLP/GMP experience.
Pharmaceutical experience and/or other regulated industry or similar experience.
Experience with the sterilization of medical devices including Steam, EtO, and Gamma processes, and testing methods associated with those processes.

Responsibilities

Quality Testing Perform Endotoxin and Bioburden testing per established procedures.
Perform Environmental Monitoring (EM) of the Cleanrooms 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 respond 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 Merz Aesthetics Medical products.
Validation Support Maintain an elevated 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 ensure product quality and Quality System requirements are met.