QC Tech IV

Endo•Raleigh, NC

10h•Onsite

About The Position

The Quality Technician IV is responsible for performing comprehensive analysis and inspection of finished goods, in-process materials, and raw materials using chemical, physical, and instrumental methods to ensure compliance with established quality standards. In addition to core testing responsibilities, this role actively supports broader Quality Control laboratory operations to maintain continuous workflow, regulatory compliance, and operational excellence. A critical function of the Quality Technician IV is serving as the primary trainer and subject matter resource for new and developing team members. This includes leading onboarding efforts, delivering structured and hands-on training, ensuring adherence to standard operating procedures (SOPs), and fostering technical competency across the team. The role is expected to proactively mentor, coach, and assess trainee performance, reinforcing best practices, safety standards, and quality expectations to build a highly capable and consistent workforce. The Quality Technician IV may work a rotating or day shift schedule, with responsibilities tailored to operational needs; however, ownership of training excellence, knowledge transfer, and team capability development remains a central expectation across all assignments.

Requirements

Minimum 5 years QC Lab experience, trained and competent in all areas, i.e., PAP Controls, APAP Controls Lab, and Finished Lot testing.
Minimum 5 years QC/QA experience or closely related field.
Experience with Mallinckrodt QC Laboratory and testing is preferred.
Working knowledge of cGMP required.
Must demonstrate advanced problem solving skills as well as leadership skills.
Must be able to comprehend and independently carry out written procedures, record results and observations, and perform mathematical calculations.
Requires familiarity with all laboratory procedures and equipment and an understanding of instrument operation.
Must have an understanding of chemical properties, like molecular weight, molecular formula, and basic reactions to prepare volumetric solutions and standards.
Sound and correct technical judgments re required during routine analysis.
Strong computer skills.
Functional/Technical Skills, Priority Setting, Written Communication Customer Focus, Organization

Nice To Haves

Associates of Science (AS) or Bachelors of Science (BS) or equivalent life science degree preferred.
Appropriate experience may be a suitable replacement for degree.

Responsibilities

Performs in process testing for internal customers.
Performs finished goods and stability testing for external customers.
Performs sampling and testing on all raw materials as assigned.
Assists with preparing and shipment of hazardous and non-hazardous samples for the QC laboratory.
Assists with QC Lab Hazardous Waste program.
Stocks laboratory chemicals and helps with checking inventory levels for ordering needs.
Assists QA as needed.
Performs specified analysis on all process control samples and all finished goods and reports results in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
Maintains accurate and precise records of all laboratory analysis using LIMS and written documentation.
Demonstrates superb documentation skills as a qualified documentation reviewer.
Troubleshoots and performs routine maintenance on laboratory instrumentation.
Takes ownership of continued education regarding instrument maintenance and troubleshooting.
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
Effectively trains others in a positive manner.
Acts as a leader in the laboratory.
Point of contact for plant and QC/QA management.
Ensures that the lab runs smoothly and all required testing is being addressed assigning tasks appropriately according to technician training.
Able to peer review all QC laboratory testing.
Act as primary reviewer/releaser of raw materials.
Manages logbook issuance and filing.
Manages sieve pan program.
Coordinates QC Lab Hazardous Waste program.
Ensures laboratory supplies and chemical stock is sufficient by monitoring inventory, ordering materials, and unloading stock.
Submits and tracks purchase requisitions for the QC laboratory.
Reviews spending on a monthly basis, escalating special purchases or items that may impact budgeting.
Coordinates periodic water and environmental testing, including scheduling external contractors for sampling and analysis.
Utilizes Quality Management Systems to record and investigate OOS and Exceptions.
Performs periodic reviews of Quality Control documents (SOPs, Work Instructions, Methods) and complete Change Controls to implement updates.
Performs preparation and shipment of hazardous and non-hazardous samples for the QC laboratory.
Assists other QC team members and QA as needed.
Assists in any non-routine analytical work needed to solve plant problems.
Works on solving problems and implementing improvements in a team environment.
Performs any quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment.
Demonstrates advanced problem solving skills to analyze and complete failure investigations and testing problems.
Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
Demonstrates the ability to work independently, stay focused, and use time wisely.
Participates in customer audits and Lab tours.
Takes ownership of own training and uses opportunities effectively to learn new testing.
Completes all required Compliance trainings in a timely manner.