Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management.

Responsibilities

• Ensure Environmental Monitoring (EM) of the facilities controlled areas is performed as required.
• Document EM testing into the EM database prior to incubation, ensure samples are correctly incubated, and record sample results in the EM database following incubation.
• Compile trending data for EM testing to support investigations.
• Audit personnel aseptic technique in controlled areas including during process simulations (media fills).
• Author laboratory event and investigation reports.
• Communicate issues between departments as appropriate.
• Communicate effectively with co-workers to ensure all required tasks are completed as expected.
• Document test data clearly and accurately. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.

Qualifications

• BS/BA Degree in Microbiology or Biology required
• A minimum of 2-5 years pharmaceutical microbiology experience
• Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification
• Microbiology coursework and laboratory work utilizing aseptic technique required
• Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred
• Must be able to lift 20 lbs.
• Ability to handle multiple tasks concurrently and complete tasks in a timely fashion
• Computer literate
• Must be able to communicate effectively across all departments and levels of management
• Understanding of laboratory instruments and methods
• Must have excellent writing skills to write clear and concise reports

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*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 a specific plan or program terms.

Job Type: Full-time

Pay: $65,000.00 per year

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person