Job Title: Quality Specialist

Job Description

Join our team as a Quality Specialist, where you will play a vital role in ensuring compliance with quality objectives and regulatory requirements within a dynamic and innovative environment.

Responsibilities

• Provide on-floor Quality Operations support for manufacturing, warehouse, and technical operations, including in-process checks and deviation identification.
• Ensure all manufacturing activities comply with GMP and regulatory requirements.
• Review and approve GMP documentation for accuracy and compliance.
• Execute product-related activities, including apheresis material receipt and final product disposition.
• Lead investigations into deviations, non-conformances, and process anomalies.
• Review and approve deviations and CAPAs, ensuring compliant resolution.
• Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams.
• Support continuous improvement initiatives to enhance quality and compliance.
• Participate in internal audits and regulatory inspections.
• Perform additional duties to support departmental goals.

Essential Skills

• 3+ years of cell therapy experience.
• 3-5 years of GMP manufacturing experience.
• Quality Assurance oversight for manufacturing floors.
• Experience with ISO 7 gowning.
• Technical and growth mindset.

Additional Skills & Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• 5+ years of experience in the pharmaceutical or GMP industry.
• Strong knowledge of batch record review, aseptic operations, and cGMP regulations.
• Proficient in investigation tools like Fishbone diagrams, 5 Whys, and FMEA.
• Ability to lead and close complex quality investigations.
• Willingness to work in ISO 7 environments.
• Flexibility to travel between facilities and work varying hours.

Work Environment

Be part of a growing CDMO specializing in Cell/Gene Therapy at a brand-new site. The work environment involves engaging with innovative technologies and maintaining a commitment to operational excellence. Flexibility in working hours, including evenings and weekends, is required. Expect a collaborative atmosphere that encourages continuous learning and problem-solving.