GMP QA Operations Specialist – On-Site

Actalent; Grand Rapids (MI); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account

Transportation benefits

Employee Assistance Program

PTO / Vacation / Sick Leave

Job summary

Actalent seeks a Quality Assurance Operation Technical Specialist for on-site work at Grand Rapids, MI. The role provides routine technical support for GMP manufacturing across multi-product facilities, driving deviation investigations, CAPAs, audits, and continuous improvement initiatives.

You will collaborate with Quality, Operations, Engineering, MSAT, and Project Management to align efforts with site objectives. On-call support and thorough documentation are essential aspects of the position.

Qualifications

• 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.

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.

Skills

GMP manufacturing operations

Deviation investigations

CAPA execution

Quality assurance principles

Technical writing

Root cause analysis

Cross-functional collaboration

On-call support

Education

Bachelor's degree in life sciences, engineering, or equivalent

Tools

Microsoft Word

Excel

Outlook

Job description

Actalent seeks a Quality Assurance Operation Technical Specialist for on-site work at Grand Rapids, MI. The role provides routine technical support for GMP manufacturing across multi-product facilities, driving deviation investigations, CAPAs, audits, and continuous improvement initiatives.

You will collaborate with Quality, Operations, Engineering, MSAT, and Project Management to align efforts with site objectives. On-call support and thorough documentation are essential aspects of the position.