POSITION OVERVIEW:

The primary purpose of the QC Environmental Monitoring Analyst Level I is to perform essential tasks of the environmental monitoring program which includes assisting with cleaning validations, performing cleaning verification protocols, and performing cleaning verification testing within the CPI production facility.  This position is also tasked with sampling, investigating, and trending of CPI's water systems, compressed air system, and production/ancillary facility (viable and non-viable air, surface, and ATP) as assigned.
The QC Environmental Monitoring Analyst Level I assists developing and/or revises existing environmental monitoring (EM) procedures, protocols, methods, and implementation of new equipment.
The QC Environmental Monitoring Analyst Level I is expected to possess a thorough understanding of CPI's EM program testing procedures and specifications.
** Accepting applications for May 2014 Grads**


ESSENTIAL JOB FUNCTIONS:

• Ensures adherence to EM SOPs, Cleaning Validation/Verification SOPs, analytical methods, protocols, company standards, and applicable regulations.
• Performs activities included in cleaning validation and verification protocols; within the QC laboratory and production facility as applicable.
• Communicates with EM Supervisor and other QC Management about cleaning validation and verification data, notifications, and investigations.
• Communicates with Production, Formulations, and QA departments when performing cleaning validation/verification activities.
• Assists in the development of new environmental monitoring procedures, protocols (i.e. method validations, transfers, and verifications) and implementation of new equipment.
• Collaborates with QC EM Technicians or other EM Analysts to complete water, air, and surface testing throughout the facility.
• Assists with microbiology research studies or protocols as assigned.
• Maintains awareness of applicable changing regulatory and industry requirements (i.e. USP, EU, JP, etc.).
• Maintains a cGMP laboratory notebook, data, forms, and/or logbook.
• Reviews laboratory notebooks, data, forms, and/or logbooks of other lab personnel.
• Assists in maintaining a clean, organized QC laboratory.
• Lifts/Carries objects weighing up to 55 lbs.
• Follows all CPI cGMP practices, policies, and procedures.
• Follows all CPI safety practices, policies, and procedures.
• Other duties as assigned.

EDUCATION/SKILLS/KNOWLEDGE REQUIRED:

• Bachelor's degree in chemistry, microbiology or other related field.
• Experience with the use and troubleshooting of laboratory equipment desirable.
• Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.
• Ability to lift object weighing up to 15 lbs. on a daily basis and up to 55 lbs. occasionally.