Overview
Medical Laboratory Technician/Medical Technologist Jobs in Kahuku, HI at Kahuku Medical Center
BioBoston Consulting- Recruitment is searching for a Quality Assurance Manager
for a leading Biotech company in Waltham, MA.
Job Summary:
The QA Manager will be responsible for managing and overseeing the company’s quality assurance program. This individual will lead a team that ensures our products meet regulatory standards and industry best practices. The QA Manager will play a critical role in maintaining and improving quality systems, facilitating audits, and ensuring all products adhere to the regulatory standards set forth by the FDA, EMA, and other relevant authorities.
Key Responsibilities:
Lead, manage, and develop the QA team, providing mentorship, guidance, and professional growth opportunities.
Oversee the development, implementation, and maintenance of the company’s Quality Management System (QMS) to ensure compliance with FDA, EMA, and other applicable regulations.
Ensure that all products meet applicable regulatory requirements and internal quality standards.
Perform internal audits and coordinate external audits, including regulatory inspections, ensuring compliance across all stages of product development.
Manage the review, approval, and implementation of CAPA (Corrective and Preventive Action) procedures.
Lead the investigation and resolution of quality issues, non-conformances, and deviations.
Ensure that all quality documentation, including SOPs, batch records, and validation protocols, are current, accurate, and compliant.
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, etc.) to identify and mitigate quality risks.
Develop and manage the annual QA audit plan and maintain audit schedules.
Drive continuous improvement initiatives within the quality function to enhance efficiency, compliance, and product quality.
Review and approve product documentation and change controls to ensure the maintenance of product quality.
Manage training programs to ensure employees are well-versed in quality standards and best practices.
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred.
+7 years of experience in Quality Assurance, with at least 3 years in a leadership role within the biotech or pharmaceutical industry.
Strong knowledge of FDA regulations, Good Manufacturing Practices (GMP), and ISO 13485 standards.
Experience with regulatory audits, including FDA inspections, and preparation of responses to inspection findings.
Proven experience in leading cross-functional teams and driving continuous improvement initiatives.
Excellent written and verbal communication skills.
Strong analytical, problem-solving, and decision-making abilities.
Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
Proficiency in using QMS software and Microsoft Office Suite.
Job Type: Full-time
Pay: $35.00 – $65.00 per hour
Schedule:
Monday to Friday
Work Location: Hybrid remote in Waltham, MA 02451
Title: Medical Laboratory Technician/Medical Technologist
Company: Kahuku Medical Center
Location: Kahuku, HI
