Principal Duties and Responsibilities

• Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions.
• Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
• May have direct client contact as needed.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required.
• Accurately collects and records raw data in logbooks and on worksheets.
• Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in SOPs.
• Perform personal gowning environmental testing, submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.
• Operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable.
• Perform Kinetic-Chromogenic LAL testing as applicable.
• Perform Environmental Monitoring, clean and disinfect cleanroom suites as applicable.
• Other duties as assigned.

Qualifications and Skills

• High School diploma or equivalent required and at least 6 years of experience, or Bachelor degree and at least one year of experience
• Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed

Technical Competencies

• Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
• Knowledge of metric system, NAMSA GLP and/or GMP testing, scientific applications, experimental design, and data evaluation.
• Ability to work in GLP/GMP environment.

Job Type: Full-time

Pay: $28.50 - $32.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Irvine, CA 92618: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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