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.
INDCQA
.png)
