Associate Scientist, QC Microbiology

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This position will work both independently and with the team to perform routine and non-routine Environmental Monitoring functions and support of Microbiology labs with microbiological testing and microbiology laboratory maintenance functions.

Shift Available:

• Sunday - Wednesday, 1 p.m. - 11 p.m.

Responsibilities:

• Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.

• Follow directions properly, work cooperatively as an individual contributor and as a team member.

• Communicate effectively with QC peers, cross-functional peers, and management.

• Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.

• Participate in Aseptic Process Validations/Media Fills.

• Perform Sterility Testing and sample aliquoting.

• Perform Viable and Non-Viable air monitoring viable surface monitoring.

• Perform and lead Environmental Monitoring Performance Qualification and Aseptic Qualifications.

• Perform Environmental Monitoring on routine basis.

• Perform microbial identification via polymerase chain reaction (PCR).

• Perform microbial isolation techniques and perform gram stains.

• Send out samples to contract labs and track results/reports.

• Evaluate environmental/personnel monitoring samples and create NOEs for action levels.

• Support Endotoxin and Mycoplasma assays as needed.

• Performs general laboratory cleaning/wipe-down.

• Perform routine maintenance of lab equipment.

• Maintain lab inventory and order lab supplies and materials.

• Receives and stock test reagents, lab supplies and test media.

• Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.

• Support continuous improvement projects related to QC.

• Assist in special projects as needed.

• Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms.

• Author non-routine Protocols/Validation Plans/ reports in support of projects.

• Assist in investigations &CAPAs associated with QC Microbiology Department.

• Support data trending and tracking of results.

• Perform all other duties as assigned by Management.

Knowledge & Skills:

• Fosters teamwork and promotes an environment that motivates others to achieve our goals.

• Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.

• Good knowledge of Microsoft Word and Excel.

• Responds to challenges and additional workload in an understanding, professional and objective manner.

• Adaptable to dynamic conditions, work practices, project timelines and changing schedules.

• Ability to multitask, prioritize workload, document properly and interpret data accurately.

• Able to communicate effectively with GDPO functional areas and external agencies.

• Flexible and willing to do all assigned tasks with positive attitude.

• Primary responsibilities will be Environmental Monitoring related tasks.

Basic Requirements:

• Requires Bachelor’s degree in Microbiology, Molecular Biology, or related discipline. An equivalent combination of experience/education will be considered.

• Minimum of 3 years' experience working in a regulate