12+ Month Contract M-F Onsite Job Summary We are seeking an experienced Operations Quality Engineer to support the production of Class III pharmaceutical products. This role will work closely with cross-functional teams to resolve technical and quality issues, drive process improvements, maintain and update manufacturing documentation, and provide day-to-day quality engineering support to operators, inspectors, and technicians involved in the manufacturing and inspection of components, sub-assemblies, and finished goods. Key Responsibilities Support manufacturing operations and cross-functional teams in resolving product, process, and technical quality issues. Investigate and resolve nonconforming material issues through the Nonconforming Material Report (NCMR) process. Lead or support Corrective and Preventive Action (CAPA) investigations and implementation of effective corrective actions. Perform thorough root cause analysis using tools such as 5 Whys, Fishbone/Ishikawa diagrams, Cause-and-Effect analysis, and other structured problem-solving methodologies. Identify opportunities for process improvement and support the implementation of corrective actions and sustainable process changes. Develop, revise, and maintain work instructions and other manufacturing or quality documentation. Support operators, inspectors, and technicians with day-to-day manufacturing and inspection activities. Provide quality engineering support for the production and inspection of components, sub-assemblies, and finished goods. Conduct or support Gage Repeatability and Reproducibility (Gage R&R) studies and other measurement system analyses. Support Test Method Validation activities to ensure inspection and testing methods are appropriate, repeatable, and reliable. Participate in equipment, process, and product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Work cross-functionally with Manufacturing, Quality, Engineering, Operations, and other teams to address production and quality issues. Analyze data, identify trends, and recommend improvements to manufacturing processes and quality systems. Ensure quality activities and documentation are completed in accordance with applicable procedures and regulatory requirements. Required Qualifications Experience as a Quality Engineer, Operations Quality Engineer, Manufacturing Quality Engineer, or similar role in a regulated manufacturing environment. Experience supporting Class III pharmaceutical products or other highly regulated products. Strong hands-on experience with NCMR and CAPA processes. Experience performing root cause analysis, including 5 Whys, Fishbone/Ishikawa diagrams, and Cause-and-Effect analysis. Experience with Gage R&R and measurement system analysis. Experience with Test Method Validation. Experience supporting

IQ/OQ/PQ

validation activities. Experience driving process improvements and resolving manufacturing quality issues. Ability to update and maintain work instructions and technical documentation. Strong problem-solving, analytical, communication, and cross-functional collaboration skills. Ability to work closely with operators, inspectors, technicians, engineers, and other manufacturing personnel in a fast-paced production environment. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

GRPB Pay:

$40.00 - $48.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance People with a criminal record are encouraged to apply

Work Location:

In person