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Laboratory Instrumentation Specialist (Temporary Position)
at TOLMAR Inc.
Purpose and Scope
Perform aspects of laboratory instrumentation including maintenance, calibrations and performance verifications in compliance with cGMP and regulatory requirements.
Essential Duties and Responsibilities
• Perform routine maintenance and qualification of instrumentation.
• Train analysts in proper instrument care.
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Accountable for proper use, care, troubleshooting and maintenance of instrumentation.
• Perform installation qualification on typical instrumentation (HPLC, GC).
• Provide detailed accounts of testing performed to investigators. Under the direct supervision of an investigator, may perform investigational testing.
• Participates in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings. Hazardous waste involvement may include but is not limited to making waste determinations, generation, transportation, satellite accumulation, storage and disposal of multiple types of waste streams, and container management and inspections. Respond to spills per company procedures. Maintain compliance to all Tolmar health and safety policies, as well as OSHA standards.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Will represent the department by providing account of equipment qualifications and validations and assist with troubleshooting aberrant equipment qualification and validation results, if necessary.
Knowledge, Skills & Abilities
- Experience in a government regulated laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
- Intermediate understanding of the use of USP, NF and other compendia.
- Effective communication skills with the ability to work independently and cooperatively on a team.
Education & Experience
- Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
- Two or more years of experience in an analytical laboratory position.
- Interest and availability for working 2nd shift, 2:00 - 11:00 PM, Monday - Friday.
- Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.