What are the responsibilities and job description for the Clinical Quality Assurance Specialist/Manager (Part-Time) position at Stratacuity: Proven Scientific Placement?
Our Waltham based client is seeking a detail‑oriented Clinical QA professional to support quality and compliance activities across oncology clinical development programs. This role helps maintain and improve the Clinical Quality Management System (QMS) and ensures clinical trials meet GCP, regulatory, and internal quality expectations. You’ll collaborate closely with Clinical Operations and cross‑functional teams to drive audit readiness, quality oversight, and process improvement in a fast‑paced biotech environment.
Key Responsibilities
• Support QMS maintenance, SOP updates, and regulatory compliance
• Assist with internal and external audits, documentation, and CAPA tracking
• Partner with Clinical Operations on quality oversight and issue resolution
• Support clinical trial documentation, processes, and TMF review
• Contribute to GCP/QA training and maintain systems such as eQMS, CTMS, and eTMF
Qualifications
• Bachelor’s degree in life sciences preferred
• 5 years in clinical development with ICH guideline familiarity
• Experience with QA, QMS, audits, or SOP development is a plus
• Strong organizational, communication, and problem‑solving skills
• Proficiency in Microsoft Office; familiarity with CTMS, eTMF, or eQMS preferred
Additional Information
• Hybrid role (minimum 2 days onsite in Waltham, MA)
• Flexible hours to support global collaboration
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
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