Description

POSITION SUMMARY

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.

PRIMARY DUTIES/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 equipments.
• 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.

Requirements

EDUCATION/EXPERIENCE REQUIREMENTS

• Fosters teamwork and promotes an environment that motivates others to achieve our goals.
• Requires Bachelor’s degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Environmental Monitoring and Microbiology lab experience strongly preferred. An equivalent combination of experience/education is acceptable.
• 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.

Working Conditions

• The incumbent will be required to wear uniform/ PPE for long durations in the manufacturing or

                 laboratory environment.

• The incumbent may be required to stand and walk for extended amount of time.
• The incumbent may be required to work hazardous materials and areas with magnetic and electric fields.
• Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
• Change to work timings and assigned tasks may occur at a very short notice to support business needs.
• Shift days and hour may change to accommodate the business needs.

 This job description is intended to describe the general nature and level of work being performed by the

person assigned to this position. The primary duties and responsibilities are intended to describe those

functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities

assigned to this position. There are other duties and responsibilities that are considered incidental or

secondary to the overall purpose of this job. Employees holding this position will be required to perform

any other job-related duties as requested by the management.