Laboratory Technician

About the role

The Laboratory Technician performs, documents, and reports Quality Control Laboratory testing. Perform packaging seal strength tests, water testing, environmental monitoring of clean rooms, data entry and verification, growth promotion tests, and any other required laboratory testing.

Operate autoclave and standard laboratory equipment (e.g., balance). Support cross-functional teams with appropriate activities. Ensure proper laboratory equipment and functionality, and appropriate levels of laboratory supplies. Initiate/draft LIRs (Laboratory Investigation Records).

• Perform Environmental Monitoring (EM) of aseptic manufacturing operations. 40% facilities. Perform on-the-spot investigations and appropriate follow-up actions under EM excursion situations under direction of senior technicians/management, and per procedure. Environmental Monitoring Requests (EMRs) in a timely manner to release cleanroom to Manufacturing per procedure. Complete personnel monitoring plating of Manufacturing technicians as requested. Sample and test water systems serving manufacturing facility and laboratories. EM includes non-viable and viable air particulate, viable surface sampling, personnel monitoring, and water sampling. Must be able to lift 25 lbs. Wear proper PPE. Follow SOPs to perform Quality Control Laboratory testing. Operate standard laboratory equipment such as balances, autoclaves, CLIMETs, Instron units, and Thermogravimetric analyzer, and air samplers.
• Maintain appropriate databases and spreadsheets to accurately report test results in compliance with current Good Laboratory and Good Documentation Practices. Perform data verification for EM results and data entry. Become a qualified peer reviewer. Ensures that records and raw data are properly recorded, reviewed and retained. Keep supervisor/upper management informed of laboratory operation status. Initiate LIRs in Global Track wise system.
• Execute non-routine test for study protocols and/or equipment re-qualifications. Ensure appropriate levels of laboratory supplies and proper functioning of equipment. Ensure disposal of solutions and media as per SOPs. Monitor preventive maintenance and calibration activities of lab equipment. Sustain 6s and keep laboratory a safe and pleasant working environment.

Qualifications & Requirements

• Bachelor's degree required of related sciences (Biology, Chemistry, Biochemistry, etc...)
• 1-4 years of performing duties in a GMP environment specifically aseptic processing facility
• Required experience in a cleanroom setting.
• Experience with routine laboratory testing and/or environmental monitoring
• Experience with standard laboratory equipment (pH meters, particle monitors, etc

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.