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Microbiology Associate I (Manufacturing)

Company: Merz North America Inc
Location: Franksville
Posted on: May 3, 2021

Job Description:

Microbiology Associate I (Manufacturing)Support the Supervisor, Microbiology with the daily operations of the Microbiology department or quality system. Supports all activities related to microbiological assessment of Merz 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 (OOS) events. Provide direct support to Quality Assurance personnel regarding operation of the department and Quality System. Hours 230pm - 1:00am M-TH 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 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 Merz 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. Education BS in Microbiology, Biology, Physical Science or equivalent experience Required Professional experience Minimum 2 years Microbiological, Biological, Quality Assurance and/or other regulated industry or similar experience GLP/GMP experience Pharmaceutical experience Knowledge, skills and abilities (incl. languages) Strong technical and general problem-solving skills required. Strong aseptic technique and understanding of microbiology Preferred experience in training of personnel Knowledge of manufacturing and quality assurance activities associated with the sterilization of Merz Aesthetics products Subject Matter Expert (SME) in product and manufacturing environment cleanliness and assist with training activities in these areas where appropriate Knowledge of methods Preferred experience with the sterilization of medical devices including Steam, EtO, and Gamma processes, and testing methods associated with those processes. 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. Personal skills Ability to work with company staff and communicate effectively throughout the organization is essential. Excellent written and oral communication skills. Other Information Must be able to pass vision testing requirements (with or without corrective eyewear). 20/20 Near Acuity Vision Color Vision acceptance - tested to Ishihara 14 plate test (12/14 pass) Color Vision is needed for 5% of this position Some clean room work may be required; no make-up or excessive amounts of jewelry allowed. Lifting of light to moderately heavy (less than 25 pounds) objects. Manual Dexterity. Experience Preferred GLP/GMP experience 2 year(s): Microbiological, Biological, Quality Assurance and/or other regulated industry or similar experience Education Preferred Bachelors or better in Biology Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) See job description

Keywords: Merz North America Inc, Kenosha , Microbiology Associate I (Manufacturing), Other , Franksville, Wisconsin

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