ROLE SUMMARY

The Defect Lab Analyst I creates defect kits following specified instructions from supervisor, SOP’s, and client specifications.   Completes all applicable documentation for the manufacture of defect kits and ensures a high level of accuracy and adherence to GDP.  Uses the Laboratory Information Management System (LIMS), other computerized systems, or standard laboratory paper-based documentation to complete kit creation. Meets required kit deliverables and informs supervisor immediately if issues arise during kit creation. 

ROLE RESPONSIBILITIES

Manufactures defect kits to meet the requirements of the customer while following SOP’s, specifications, and ensuring particulate free production.   

Generates valid data and completes all required documentation to establish kit traceability while adhering to cGMP’s.

Maintains equipment and trouble shoots instrumentation problems, procedural problems or production problems.

Participates in functions involving teams which impact production, increase efficiency, solve problems, generate cost savings and improve quality. 

Perform review of defect kit data, which includes overall documentation practices. 

Prepares summary reports and memos.  Writes and reviews SOP’s and revises defect lab procedures.

Ensures safety, housekeeping, and compliance are maintained.

Completes the review of inspection data and uses equipment to complete the inspection of applicable units when required. 

Performs other duties as directed by supervisor.

Perform other related duties as assigned or required.

QUALIFICATIONS

• HS Diploma with 0-1 years job related experience required.
• Must be detail oriented, conscientious and have high reading comprehension skills.
• Demonstrate proficiency in computerized systems.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Must be able to perform a variety of kit creation tasks as required within the work area.
• Must be able to communicate effectively with supervisors and peers.
• Comprehend mathematical concepts such as conversions, fractions, decimals, and rounding.
• Ability to understand and follow written procedures.
• Must be self-motivated and work with minimal direction.
• Utilize good judgment in making decisions within limitations of recognized standard methods and procedures.
• Must maintain cGMP compliance within the assigned laboratory.
• Demonstrate creativity, flexibility, teamwork, and leadership skills.
• Complete all training and written exams.
• Must be able to temporarily work a flexible schedule to meet business needs.

PHYSICAL/MENTAL REQUIREMENTS

USE MICROSCOPE AND COMPUTER TERMINAL FOR UP TO 8 HOURS PER SHIFT.  EXPOSED TO DRUG PRODUCTS AND CHEMICALS.  MUST WEAR PPE (SAFETY GLASSES, ETC.)  WORKS IN A CONTROLLED LABORATORY ENVIRONMENT WHICH IS MONITORED FOR PARTICULATE.

Standing up to 3-4 hours, sitting for up to 5-6 hours, twisting at waist 2 times per hour, regularly lift up to 10 pounds per activity 10 times per shift, occasionally lift a maximum of 50 pounds per activity 2 times per shift.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May require OT and work on non-scheduled days given production.

Relocation assistance may be available based on business needs and/or eligibility.