Job description

Qualifications:

Education – BA or higher in biological, chemical, or engineering sciences. 4+ experience (including experience validating LCMS systems; experience with Analyst application preferred). Experience working within a GLP or GMP laboratory, preferably in a bioanalytical lab.

• Experience scheduling & performing laboratory equipment maintenance and/or conducting computer system validations
• Highly organized, and capable of multitasking to manage a variety of equipment or system related schedules, documents, and maintenance tasks
• Capable of working independently under moderate supervision
• Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

Responsibilities:

Candidate will work within the metrology team that supports regulated equipment and systems used within a GxP regulated bioanalytical laboratory. Primary focus will be participating in and driving computer system validation efforts associated with bioanalytical laboratory computerized systems, including LCMS systems, liquid handlers, plate readers/imagers, qPCR, flow cytometer, etc.. Activities will include: Developing a working understanding of laboratory equipment and software applications, Working with equipment vendors to appropriately setup system within a GxP environment, Generating and/or updating system requirements, Partnering with IT to establish system accounts and data flow pathways, with a focus on data integrity principles, Partnering with document writers, IT, and Quality in the generation, review, and executing of system validation acceptance test documents, System validation efforts may be for new system implementation, or part of change controls to upgrade or retire existing systems, Individual should have experience validating computerized systems within a regulated environment operating under SOPs.

Job Type: Full-time

Pay: $50.00 - $60.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 4 years

Schedule:

• 5x8
• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Work setting:

• In-person
• Manufacturing facility

Experience:

• GLP or GMP laboratory: 4 years (Preferred)
• SOP: 4 years (Required)
• LCMS Systems: 4 years (Required)

Work Location: One location

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