QA Process Specialist

At Apex International, we take pride in our commitment to manufacturing high-quality OTC, personal care, and household products. We strive to build collaborative partnerships with a diverse range of customers, including global Fortune 100 companies and entrepreneurial start-ups.

We are seeking a detail-oriented and results-driven Quality Process Specialist to join our Quality team.

Location:

Eden Prairie, MNThe Quality Process Specialist will contribute to the success of our customers and operations by driving continuous improvement in quality systems and processes that improve first-time-right performance, product quality, regulatory compliance, and customer satisfaction. This role is responsible for leading quality event investigations, CAPA management, Annual Drug Product Review activities, and supporting quality audit programs.

Job

Responsibilities and Duties:

Percentages = priority and approximate time focus

Ensure quality events are thoroughly investigated and processed in a timely manner in accordance with SOPs, regulatory requirements, and customer agreements.

Facilitate investigations to ensure event analysis utilizes data to identify true root causes and effective corrective actions.

Prepare customer complaint investigation summaries and customer-required reports.

Ensure customer responses are accurate, complete, and provided within required timelines.

Review CAPAs upon initiation to verify appropriate root cause determination and corrective actions.

Partner with stakeholders to ensure proposed CAPA actions and deadlines are understood and supported prior to approval.

Drive CAPAs to closure within established timelines.

Conduct and document CAPA effectiveness checks in accordance with established procedures.

Manage and support the Annual Drug Product Review (ADPR) process to ensure regulatory compliance and business visibility.

Coordinate completion of Annual Drug Product Reviews according to established schedules.

Maintain and monitor ADPR schedules, milestones, and status tracking.

Compile, analyze, and summarize quality and manufacturing data for inclusion in ADPR reports.

Prepare and complete final ADPR reports in a timely and accurate manner.

Utilize visual management tools to drive accountability and ensure completion of review activities.

Support quality systems and continuous improvement initiatives.

Evaluate quality processes and identify opportunities to improve effectiveness, compliance, and efficiency.

Analyze quality trends and metrics to identify recurring issues and improvement opportunities.

Participate in investigations, corrective actions, and quality improvement projects.

Support the development and implementation of process improvements that enhance product quality and customer satisfaction.

Provide support to the Apex Quality Audit Program.

Conduct internal audits as assigned and document findings in accordance with established procedures.

Support audit preparation activities and follow-up on corrective actions related to audit observations.

Assist in maintaining compliance with regulatory, customer, and internal quality requirements.

Participate in customer, regulatory, and certification audits as needed.

Understand and maintain a culture of "lean action" within the department so that we live lean better than any organization.

Implement and maintain standards and processes that eliminate waste throughout the department.

Apply and utilize lean tools to permanently implement improvements.

Institutionalize and sustain 5S principles throughout the department (Sort, Straighten, Shine, Standardize, and Sustain).Actively participate in continuous improvement projects and lean initiatives.

Provide cross-functional support to quality and operational teams.

Collaborate with Manufacturing, Quality Control, Research & Development, and Customer teams to address quality concerns and process improvements.

Support customer requirements, quality initiatives, and regulatory compliance activities.

Assist with departmental projects and business objectives as assigned.

Other duties as assigned.

Qualification and Skill Requirements:

Prior

Experience:

This position requires 1-3+ years of experience in a Quality role within a cGMP manufacturing environment. Experience supporting quality systems, investigations, CAPA programs, audits, customer complaints, or regulatory compliance activities is preferred.

A Bachelor's degree in Quality Assurance, Biology, Chemistry, or a related scientific discipline is preferred. Equivalent education and experience will be considered.

Knowledge Requirements:

To be effective, this position requires strong organizational skills, attention to detail, and the ability to manage multiple priorities while demonstrating a strong sense of urgency. Candidates should possess knowledge of quality systems, CAPA processes, root cause analysis methodologies, audit programs, continuous improvement practices, and regulatory compliance requirements.

Experience working in a cGMP environment is preferred. Strong analytical,…