QA Regulatory Specialist

This position in onsite Monday-Friday out of our Waukesha location.

Position Summary

The QA Regulatory Specialist is responsible for supporting the development, maintenance, and implementation of quality standards, policies, and procedures to help ensure compliance with applicable regulatory requirements and company standards. This position partners with internal and external stakeholders to support quality assurance and regulatory activities related to product distribution and operations.

Essential Functions

• Oversee and monitor distribution activities for conformance with established quality control standards and procedures, including temperature-controlled areas where applicable.
• Track, investigate, and support resolution of non-conformances, corrective and preventive actions (CAPAs), deviations, and change controls.
• Support compliance with applicable regulatory requirements and Good Manufacturing Practices (GMP) related to the distribution and handling of regulated products.
• Develop, maintain, and provide training on standard operating procedures (SOPs) and help ensure applicable processes are performed in accordance with established procedures.
• Support product inspection, sampling, and quality assurance activities in accordance with applicable requirements and company procedures.
• Partner with internal and external quality and regulatory resources on product compliance, quality, and regulatory matters.
• Investigate and coordinate product recalls, returns, and/or destruction activities in accordance with applicable regulatory requirements and company procedures.
• Maintain required quality and regulatory documentation, records, and product samples, as applicable.
• Develop and/or deliver appropriate quality, regulatory, and SOP training and maintain associated training records.
• Participate in and provide support for regulatory inspections and audits.
• Collaborate with manufacturers, suppliers, and other business partners regarding regulatory questions, quality concerns, and product information.
• Identify opportunities for process improvement and support implementation of quality and compliance initiatives.
• Comply with company and department policies and standards and perform other duties as assigned.

Minimum Qualifications

Education

• Bachelor’s degree in Science, Chemistry, Biology, Pharmacy, or a related field.

Experience

• Minimum of 2 years of compliance, quality assurance, and/or regulatory experience.
• Experience developing, maintaining, and implementing standard operating procedures
• Working knowledge of Good Manufacturing Practices (GMP).

Knowledge, Skills & Abilities

• Strong analytical and problem-solving skills.
• Strong attention to detail and organizational skills.
• Strong written and verbal communication skills with the ability to effectively engage internal and external stakeholders.
• Knowledge of process improvement tools and techniques.
• Proficiency with Microsoft Office applications, including Excel, Word, and Outlook.
• Ability to interpret and apply regulatory requirements, policies, and procedures.
• Ability to work collaboratively across functions and manage multiple priorities.

Travel

5% travel may be required based on business needs.

The potential compensation range for this role is below. The final offer amount could exceed this range, based on various factors such as candidate location (geographical labor market), experience, and skills. $96,500.00 - $128,700.00