Quality Assurance Specialist

Quality Assurance Specialist - Permanent - Billerica, MA

Proclinical is seeking a Quality Assurance Specialist to join a global leader in the life sciences industry. This is a permanent position located in Billerica, MA.

Primary Responsibilities:

This role is pivotal in providing quality assurance support for various sites, with a significant focus on audits. The successful candidate will be responsible for enforcing and complying with GxP Practices and Quality Control Procedures.

Skills & Requirements:

• Bachelor's degree in Life Sciences/Engineering or related field.
• Experience in Quality Assurance.
• Experience performing internal audits.
• Familiarity with ISO 9001.
• Strong analytical skills and creative thinking.
• Excellent leadership skills and the ability to work across the organization.
• Strong communication, interpersonal, and collaborative skills.
• Ability to work independently and show a high level of initiative.
• Proficiency in Microsoft Office Products.
• Experience in a GxP facility is a plus.
• Experience with Continuous Improvement initiatives is a plus.
• Project management experience is a plus.
• Six Sigma certification is a plus.

The Quality Assurance Specialist will:

• Independently schedule and host client audits and respond to audit findings promptly.
• Conduct internal audits for all North American Life Sciences facilities, including regional and client sites.
• Assist with the implementation and improvement of the global quality system within Life Sciences through gap analysis and remediation.
• Regularly review and approve equipment validation documents.
• Compile the Management Review Meeting Presentation, including interpretation of data and charts.
• Review Change Request for Global Operations.
• Provide direction and leadership to ensure compliance with GxPs, ISO 9001, and federal and local guidelines and regulations at Customer and Regional Sites.
• Provide regional QA support as needed.
• Act as a system administrator in Qualtrax®.

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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