Quality Tech 2

Direct Digital LLC•West Valley City, UT

5d•$17 - $19

About The Position

The Quality Technician II helps ensure product integrity and regulatory compliance throughout manufacturing. The role performs inspections, testing, and documentation for raw materials, in-process components, and finished goods. It supports quality initiatives by enforcing GMP standards, conducting internal audits, resolving non-conformances, and implementing corrective actions. This position acts as a mentor and indirect lead to junior quality staff and collaborates across departments to uphold quality standards, improve processes, and support continuous improvement. It may provide coverage for Quality Technician I duties and serve as a provisional backup for the Quality Supervisor when assigned by the Director or Assistant Manager. The role requires analytical skills, attention to detail, and the ability to work independently in a manufacturing environment.

Requirements

Previous work experience in quality control or a related field.
Strong attention to detail.
Strong analytical and critical-thinking skills.
Excellent written and verbal communication skills.
Proficiency in Microsoft Office.
Proficiency in reading and writing English to meet FDA record-keeping requirements.
Competency in addition, subtraction, multiplication, division, calculating percentages, and determining simple mathematical formulas.
Ability to walk, stand, bend, and reach frequently throughout the shift.
Ability to lift up to 20 pounds.
Ability to comply with GMP environment and PPE requirements.

Nice To Haves

High school diploma or GED preferred; equivalent experience may be considered on a case-by-case basis.

Responsibilities

Assure consistent quality and oversee inspections, physical testing methods, and procedures.
Enforce good manufacturing practices and systems by verifying processes and reviewing documentation.
Contribute to quality action plans, identify and resolve problems, determine system improvements, and implement changes while enforcing policies and procedures.
Analyze variances and initiate corrective actions to achieve quality objectives.
Document quality evidence, identify critical control points and preventive measures, and monitor and verify procedures.
Assist in writing and updating quality procedures.
Maintain and improve product quality through surveillance audits and compliance with company policies, systems, and procedures.
Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions, and re-validations.
Conduct testing procedures on equipment during manufacturing to ensure products meet quality standards.
Inspect finished goods for defects, weights, and other quality criteria throughout the manufacturing process.
Oversee rework through inspection and physical testing methods and procedures.
Pull incoming raw material and finished product samples for testing; inspect and verify incoming and outgoing products and paperwork.
Oversee and update in-process product inspection standards.
Maintain product quality by enforcing quality policies and procedures.
Accurately update quality logs, including lab submissions, skip-lot testing, MRB, and expired products.
Sample, examine, and document materials and finished products.
Conduct and report internal audits and evaluations.
Implement and improve quality-control operating procedures.
Support management of outside laboratory testing, material review, and release procedures.
Provide timely turnaround on OOS, NCR, and CAPA activities, especially those involving incoming raw materials and finished products before release.
Perform in-house in-process or incoming-material testing as needed using equipment in the sampling laboratory.
Coach and monitor other quality technicians as needed, reporting performance to quality management.
Cover Quality Technician I responsibilities when the department is short-staffed.
Provide provisional backup for the Quality Supervisor when assigned by the Director or Assistant Manager.
Adhere to cGMP requirements in production areas and monitor and enforce other team members' compliance.
Coach and train fellow employees on appropriate compliance with cGMP standards.
Monitor and report consumable inventory, equipment calibration and performance, and other items needed to maintain the sampling and testing laboratory and process.
Facilitate interdepartmental cooperation to support effective production and continuous improvement in companywide quality standards.
Maintain a clean and safe work environment.
Perform other projects as assigned.