Job Description: Quality Laboratory Technician
Onsite, Warren NJ
Local Candidates Only
Work Schedule: Mon - Fri, Business Hours
*Some weekends required as needed*
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.
- Ability to multi-task and work flexible work schedule.
- Intermediate written and verbal communication skills.
- Ability to interpret and write general business documents and technical documents.
- Ability to follow direction well, work cooperatively as an individual contributor and as a team member.
- Ability to gown and maintain a sterile work environment.
- Ability to work independently for extended periods of time.
- Perform Environmental Monitoring on routine basis.
- Collect viable and non-viable samples within controlled environments.
- Collect viable and non-viable samples for compressed gases.
- Collect personnel glove and gown samples.
- Participate in aseptic process qualifications, such as aseptic gowning and media reads.
- Perform microbial isolation techniques and perform Gram stain identifications.
- Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
- Send out samples to contract labs and track results/reports.
- Communicate effectively with QC peers, cross-functional peers and management.
- Performs general laboratory cleaning/wipe-down.
- Perform routine maintenance of lab equipment.
- Under the guidance of management, support special project work.
- Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.
- Enter data in CELabs LIMS System
Education and Experience Required:
- Bachelor s degree preferred, preferably in science or related field.
- Microbiology lab experience strongly preferred
- Minimum 4 years of Environmental Monitoring experience
- Understand USP, EP, JP, and FDA microbiology testing requirements
- Intermediate level experience with Microsoft Word and Excel.
- Experience using LIMS required; CELabs LIMS Systems preferred
- Responds to challenges and additional projects in an understanding, positive, and objective manner.
- Adaptable to dynamic conditions, work practices, and project timelines.
- Ability to multitask, prioritize workload and interpret data accurately.
- Able to communicate effectively with functional areas and external agencies.
- Fosters teamwork and promotes an environment that motivates others to achieve our goals.
Additional Job Requirements:
Lab w/o blood & animal