Environmental Monitoring Microbiologist Jobs

Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN, MODA)

Coach and mentor personnel, including one-on-one meetings, team meetings, performance management and personnel development plans.

Lead and manage relationships with third party testing laboratories, as required.

Provide support for internal and external auditing processes, including acting as a key presenter and tour lead for areas managed.

At least five years of relevant, hands-on experience working within a microbiology laboratory.

At least two years of experience as a people leader.

Excellent communication skills (oral and written) and data management skills.

Maintain laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activities.

Ideal candidates will have a strong background in microbiology with 2-3 years of GMP experience.

Experience performing environmental monitoring testing and/or microbiological testing preferred.

Strong adherence to data integrity requirements.

Ability to learn regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to environmental monitoring.

Possess oral and written communication skills for communicating to employees, management, and other departments.

Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.

High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.

Possess interpersonal skills and demonstrated teaching/coaching experience.

Coordinate environmental monitoring activities and assign job responsibilities to QC Environmental Monitoring Technician(s).

4+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.

Experience with grade A-C aseptic gowning

Strong water, clean steam, and air sampling skills

experience with grade A-C aseptic gowning

strong water, clean steam, and air sampling skills

Coordinates forums and working groups for defining requirements, entry and exist criteria, and execution and evaluation of technology.

Responsible for Science and Technology Planning for terrestrial weather and space environment mission areas with 10 years’ experience in technology development.

Responsibilities Include, But Are Not Limited To

Requires Master’s degree in meteorology and space physics with practical applications.

Secure our Nation, Ignite your Future

May participate in equipment and method qualifications, validations, and method transfers

Perform data entry utilizing good documentation practices

BS in a relevant scientific discipline or 5 years Quality Control experience in a cGMP organization with a focus in Microbiology

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Good practical knowledge of cGMP requirements.

5 years’ experience in a QC job.

At least BS in a relevant scientific discipline.

Generous compensation and relocation package are provided.

Please apply if you have:

For more information, please contact Ayrin Majidi at [email protected] or submit the form below.

Six months experience in monitoring ambient air quality.

Knowledge of PC-based Data Acquisition Systems.

Six months experience in analyzing and evaluating scientific data.

Six months experience in interpreting laws, rules, regulations, standards, policies, and procedures.

Six months experience in using an automated information system to enter, update, modify, delete, retrieve/inquire and report on data.

Six months experience in technical report writing.

1+ years of experience in a GMP environment.

Excellent written and verbal communication skills.

Associate Degree in Chemistry, Biology, or other life science discipline.

Ability to work in a team environment.

Ability to work in analytical testing labs with hazardous and toxic chemicals.

Follow all job-related safety and other training requirements.

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations.

This position does have a few physical requirements:

Perform analyses including instrumental and automated methods using prescribed procedures and techniques.

Generate valid data, report results on appropriate database compared to established specifications while adhering to GMPs.

Compare laboratory results with specifications for acceptability and determine if repetition or OOS is required.

Technical Skills- Knowledge of laboratory equipment, testing and technique.

Basic math skills and computer skills, such as data entry, along with a high level of attention to detail

Demonstrate proficiency in computerized systems, such as Laboratory Information Management System

Manage own time, professional development and accountable for own results.

Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.

Ensure all reagents and reference standards are valid and stored according to requirement.

Escalate to management any failures and concerns related to environment of controlled spaces.

Maintains working knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.

Manage the incubation of samples, plate reading and reporting of results. Accurately completes GMP reviews as assigned.

Participates in company training and maintains current status of certifications.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Bachelor’s degree in Microbiology or similar field and no related experience required.

Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management.

Uses experience and knowledge to solve problems, make decisions or make plans for their area. Makes recommendations for department.

Prioritizes work of team based on input from management and is able to clearly communicates rationale for priorities.

Performance and coordination of environmental monitoring. Level 1 and 2 gowning qualification is required.

Advanced years of experience in Quality Control

Level 3 gowning qualification is required

Must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.

Prior experience in a people management role strongly preferred.

Attend and present quality metrics at the Site Quality Review Team / Management Review Meetings

Knowledge of all drug products and medical devices and combination products to assure compliance with applicable regulatory requirements

OR Masters Degree with more than 3 years of experience

Strong analytical and problem-solving abilities.

Prior aseptic gowning and environmental monitoring experience in a GMP environment

Experience with various microbial Identification systems (biochemical, MALDI-TOF, DNA sequencing)

Experience with Laboratory Information Systems (MODA, Lab Vantage, etc.)

Experience with Word, Excel, PowerPoint, and Smart Sheet

Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment

Excellent communication skills (verbal and written)