Quality Systems Specialist

Overview

EPM Scientific is collaborating with a commercial-stage specialty biopharmaceutical company to recruit a Quality Assurance Specialist who will be instrumental in supporting and enhancing the company's Quality Management System (QMS) and ensuring compliance across commercial manufacturing operations.

This role exists within a lean, team-oriented setting where the specialist will work closely with both internal departments and external manufacturing partners to support quality systems, documentations, investigations, and continuous improvements. It is a prime opportunity for professionals seeking to expand their quality assurance skills and take on more responsibility in a growing organization.

Key Responsibilities

• Assist with developing, maintaining, and improving the QMS, including managing the electronic QMS platform.
• Oversee document control processes such as creation, revision, review, approval, and archiving of controlled documents.
• Create and upkeep quality procedures and related documentation.
• Organize and implement quality training to ensure adherence to internal policies and regulatory requirements.
• Initiate and manage change control processes, including assessment, approval, and implementation.
• Collaborate with external manufacturing partners to support quality activities and uphold quality agreements.
• Lead investigations related to customer complaints, including root cause analyses and follow-up actions.
• Provide support for deviations, CAPAs, investigations, and other quality system processes when needed.
• Track quality metrics and identify areas for ongoing improvement.
• Work alongside cross-functional teams to promote compliance and meet company objectives.
• Support regulatory inspections and both internal and external audits.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or a comparable scientific field.
• Five to eight years of quality assurance experience within pharmaceutical, biotechnology, or other regulated industries.
• Experience with electronic Quality Management Systems (eQMS); familiarity with ZenQMS preferred.
• Sound knowledge of current Good Manufacturing Practices (cGMP) and quality system regulations.
• Practical experience in document control, training management, change control, investigations, and managing complaints.
• Experience working with external manufacturing partners or Contract Development and Manufacturing Organizations (CDMOs).
• Excellent communication, organizational and problem-solving abilities.
• Capability to thrive in a collaborative and fast-paced environment.