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Title: Quality Control Microbiologist II

Full Time

Location: Pleasant Prairie, WI

Our Company

Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

Summary

Nexus Pharmaceuticals, Inc. is looking to recruit a Microbiologist to join a growing company. Using standardized procedures, the candidate will conduct a variety of microbiological laboratory testing on raw materials, in-process, stability, and finished products. This position also includes environmental sampling in aseptic processing areas. The sampling performed supports high through-put pharmaceutical manufacturing.

Responsibilities:

• Performs environmental monitoring of filling rooms and supporting areas to support qualification and routine monitoring
• Performs compressed air and gas sampling and testing to support system qualification activities and routine maintenance.
• Performs sampling of water and pure steam to support system qualification activities and routine maintenance
• Incubation and reading of test samples
• Performs bioburden testing of water and in-process samples to detect microorganisms and to obtain information on types and levels of microbial contamination
• Performs testing of biological indicators to support validation studies
• Performs endotoxin testing on water, raw materials, and finished products
• Performs sterility testing on finished products
• Performs bacteriostasis/ fungistasis testing for sterility test method suitability
• Performs method suitability on raw materials and finished products for endotoxin and bioburden testing
• Performs AET routine and suitability testing
• Executes protocols for laboratory studies
• Performs microbial edentifications
• Performs daily, weekly, and monthly lab maintenance and stocks supplies
• Prepares reagents and standards used for testing
• Receives incoming samples for testing
• Performs incoming material testing and inventory
• Maintains laboratory equipment - cleaning and calibration
• Writes environmental investigation reports and Laboratory Investigation Reports
• Data entry of results generated by Laboratory
• Complies with applicable GMPs
• Maintains good practices with regards to processes and /or internal conditions leading to an aseptic environment
• Maintains laboratory logbooks and other forms to document proper GLP testing
• Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice
• Open to a flexible and fluid work environment
• Contributes to the completion of specific team objectives and assigned project milestones
• Operates within established HR policies and basic colleague relations guidelines
• Other duties as assigned

Desired Characteristics:

• Good oral, written and interpersonal communication skills within a diverse team setting are required
• Proficient math skills and computer skills in Microsoft Word, Excel and Outlook, along with a high level of attention to detail are required
• The successful candidate will possess a demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task), and be able to meet objectives in a flexible, team-oriented environment

Education or experience:

• Bachelor’s degree in microbiology or a related field with 4-6 years related work experience in a QC microbiology laboratory. Aseptic filling experience preferred.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
• Proficient in aseptic technique

Travel Requirements:

• 0-5% travel required for this role

Physical Requirements:

• Regular (50% - 69%) exertion including standing/walking for extended periods of time, lifting/carrying more than 15 and up to 25 pounds
• Works with chemicals and wears basic personal protective equipment (PPE) (glasses, gloves, ear protection), and restrictive PPE (tyvek suits, respirators), operates lab instruments
• At times low physical effort includes sitting, and operating computers or other small equipment

DISCLAIMER: The list under Role Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.

EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.