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Responsible for the handling and preparation of samples for testing. Maintaining and documenting accurate records. Assisting with the verification and reporting of test results.
Requirements / have to haves not listed elsewhere
1. Strong understanding of cGMPs, GLPs and regulatory standards/requirements for Environmental Monitoring.
2. Strong documentation skills and attention to detail.
3. Strong teamwork and interpersonal skills/communication
4. Strong computer skills in Microsoft Office products and Manufacturing Execution Systems (e.g. HMI, PMX, SAP).
5. Ability to work in PPE - gloves, safety glass/goggles, lab coat
Primary Position Responsibilities (major or daily tasks)
The Environmental Monitoring (EM) Lab Technician provides support
for EM operations by managing samples that are collected from
incubation, data/ result entry and is responsible for maintaining and
filing all data according to GMP documentation procedures. The EM Lab
Technician assists in the identification, escalation and investigation
of non-conformances and provides data retrieval support for reviews,
reports, qualifications, protocols and projects.
1. Responsible for maintaining a safe work environment, working safely and accountable for supporting all health, safety, and environmental Corporate and Site goals.
2. Ensure compliance with current Good Manufacturing Practices (cGMPs) and maintain constant inspection-readiness.
3. Ensure integrity of data collected is maintained with accurate and complete documentation.
4. Support execution of qualification activities and special projects as necessary.
5. Successfully interact with and support EM and production processes.
6. Participate in process streamlining and continuous performance improvement.
7. Generate and provide EM data as necessary for investigations, protocols and batch disposition
Requirements / have to haves not listed elsewhere
1. Strong understanding of cGMPs, GLPs and regulatory standards/requirements for Environmental Monitoring.
2. Strong documentation skills and attention to detail.
3. Strong teamwork and interpersonal skills/communication
4. Strong computer skills in Microsoft Office products and Manufacturing Execution Systems (e.g. HMI, PMX, SAP).
5. Ability to work in PPE - gloves, safety glass/goggles, lab coat