QC Environmental Monitoring
Requisition-ID: BIO20062025
Location: 100 Rodolphe Street Durham NC 27712
Duration: 6 months
Shift: 2nd Shift, Monday – Friday, no travel required.
Job Description
The QC Environmental Monitoring (EM) Analyst 1 role is responsible for routine EM testing.
The responsibilities of this position include:
Testing of environmental samples, raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.
Investigational writing.
Primary Duties
- Quality
- Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
- Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
- Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
- Prepares for regulatory, customer, and internal audits of EM laboratory areas.
- Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
- Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
- Documentation/Training
- Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
- Ensures personal training is maintained to current department processes and procedures.
- Safety
- Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
- Continuous Improvement
- Participate in continuous improvement activities.
- 6S: Maintain the laboratory and other specific c testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
- Other Duties
- Performs additional job-related duties as assigned by management.
Must have qualifications:
- Aseptic technique
- Good Documentation
- Practices Environmental
- Monitoring Experience
Years of Experience:
- 0-2 years plus Bachelor's degree or 2+ years with high school diploma