Job Title: Quality Assurance Specialist
Location: Boston, MA
Duration: Long Term
Job Summary
We are seeking a dedicated Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring compliance with cGMP standards by managing and investigating deviations in the manufacturing process. You will work closely with cross-functional teams to review and document quality issues, develop corrective actions, and maintain the highest standards of product quality.
Key Responsibilities
- Investigate and resolve deviations in the manufacturing process.
- Review and approve quality-related documents, including Master Batch Records, test protocols, and validation reports.
- Ensure compliance with cGMP regulations and company standards.
- Document findings of non-compliance and assist in developing remediation strategies.
- Monitor and review the effectiveness of corrective and preventive actions (CAPA).
- Collaborate with other departments to ensure that quality standards are consistently met.
Qualifications
- Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biological Sciences, or a related field.
- 2-10 years of experience in a cGMP environment, preferably in the pharmaceutical, biotechnology, or medical device industries.
- Strong understanding of cGMP regulations and quality assurance practices.
- Excellent documentation and communication skills.
- Experience with quality systems, deviation management, and CAPA processes.