Quality Assurance Operation Technical Specialist

About the role

The Quality Assurance Operation Technical Specialist provides routine technical support for GMP manufacturing operations across multi-product manufacturing, fill, and finish facilities. This on-site role focuses on cross-functional deviation investigations, corrective and preventive actions (CAPAs), audit support, targeted innovations, and initiatives that enhance overall plant performance. The specialist collaborates closely with Quality, Operations, Continuous Improvement, Engineering, MSAT, and Project Management teams to support site objectives and must be able to work an on-call schedule to provide technical support and site deviation analysis when needed.

The position is primarily office-based within GMP manufacturing facilities, with regular visits to the manufacturing floor to communicate with subject matter experts and observe processes. It is a contract position based out of Grand Rapids, MI, requiring on-site presence and availability for on-call technical support and deviation analysis as needed.

Responsibilities

• Execute routine technical support activities for GMP manufacturing operations across multi-product manufacturing, fill, and finish facilities.
• Lead and participate in cross-functional deviation investigations to identify root causes and propose effective corrective and preventive actions.
• Develop, document, and implement CAPAs and action items (AIs) to address process deviations and improve manufacturing performance.
• Support audit preparation and audit activities by providing technical documentation, data, and explanations related to quality operations.
• Contribute to targeted innovation projects aimed at improving plant performance, process robustness, and overall operational efficiency.
• Collaborate closely with Quality, Operations, Continuous Improvement, Engineering, MSAT, and Project Management to align technical support with site objectives.
• Provide on-call technical support and perform site deviation analysis as needed to ensure timely resolution of issues impacting manufacturing.
• Prepare clear and accurate technical documentation, including investigation reports, CAPA records, and other quality-related documentation.
• Engage with subject matter experts on the manufacturing floor to gather information, validate findings, and ensure practical implementation of solutions.
• Support continuous improvement initiatives by applying root cause analysis and quality tools within a GMP environment.

Requirements

• Bachelor’s degree in life sciences, engineering, or equivalent training and/or experience.
• Entry-level experience (0–3 years) in pharmaceutical manufacturing.
• Experience or strong understanding of GMP manufacturing operations.
• Proficiency in quality assurance and quality control principles in a pharmaceutical or GMP environment.
• Strong technical writing skills for documenting investigations, CAPAs, and quality records.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.
• Familiarity with the pharmaceutical industry and applicable regulatory expectations, including FDA-related requirements.
• Strong aptitude in root cause analysis and CAPA execution within a GMP environment.
• Previous experience in a contract manufacturing organization (CMO) is preferred.
• Experience in sterile filling, manufacturing, and/or fill-finish environments is preferred.
• Exposure to or experience with LEAN or Six Sigma methodologies is a plus.
• Ability to work effectively in cross-functional teams, including Quality, Operations, Engineering, and Project Management.
• Strong communication skills to interact with subject matter experts and present technical findings clearly.
• Ability to manage on-call responsibilities and respond promptly to technical support needs and deviation analyses.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital