Quality Management Specialist

As a Quality Specialist, you will play a pivotal role in reviewing and evaluating documentation against GMP requirements for the manufacture of drug excipients, such as poloxamer. You will identify gaps, recommend remediation actions, and ensure compliance with GMP standards. This role involves drafting, revising, and managing SOPs, work instructions, and quality records to align with compliance requirements. You will also support training efforts related to new or revised procedures.

Responsibilities

• Review and evaluate documentation against GMP requirements for drug excipient manufacturing.
• Report on identified gaps and recommend necessary remediation actions for GMP compliance.
• Draft, revise, and manage SOPs, work instructions, and quality records.
• Support training efforts related to new or revised procedures.
• Monitor progress of remediation activities to ensure delivery of GMP compliant documentation within deadlines for qualification and validation batches.
• Prepare and present status updates and reports to quality management.
• Ensure all remediation activities are completed within the defined timeline and meet FDA expectations.

Essential Skills

• Experience leading GMP compliance efforts for drug excipient or API manufacturing.
• Experience with QMS audits for GMP compliance and contributing to audit or quality management teams.
• Experience creating and maintaining remediation activities and quality documentation.
• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Minimum 5 years of experience in pharmaceutical quality management.
• Proven experience with GMP quality audits, inspection readiness, and remediation.
• Strong understanding of GMP quality systems and documentation practices.
• Excellent communication, organizational, and analytical skills.
• Ability to work independently in a fast-paced, deadline-driven environment.
• Familiarity with electronic quality management systems (eQMS).

Additional Skills & Qualifications

• Comfortable working onsite with an internal quality management expert in a collaborative environment.
• Ability to take the lead on quality gap assessments and work with the client QM to develop remediation plans.
• Willingness to track work completed on a weekly basis and monitor deliverables.
• Ability to organize schedule and work independently.