Title: Senior Associate Quality Assurance
Summary: A global leading specialty generic pharmaceutical company is currently seeking a driven and motivated Senior Associate Quality Assurance to lead their Billerica, MA plant. You will conduct all principal duties related to the quality of products and services, perform compliance investigations and audits, and constantly collaborate with all departments to drive consistency and clarity. Do you want to help make a difference in improving people's lives through high-quality, affordable medicines? If yes, please reach out to learn more.
The Senior Associate Quality Assurance will be responsible for…
- Performing in-process checks, inspections, and internal/external compliance audits
- Reviewing batch records to verify all the limits and specifications have been met, raw materials and solutions are tested and released according to the appropriate system, and correcting deficiencies
- Monitoring and tracking compliance actions arising from regulatory inspections, facilitating its review
- Implementing CAPA timelines and guidelines in collaboration with the corporate compliance group
The Senior Associate Quality Assurance should have the following qualifications:
- Knowledgeable of the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws, and regulations
- Well versed in global CAPA
The firm offers benefits covering medical, dental, vision, and retirement as well as programs aimed at helping you improve your own health and well-being.
- 401k company match begins day one (100% vesting immediately)
- Telehealth and behavior health services with prescription drug coverage
- Corporate discounts on entertainment and consumer goods
If you are interested in the Senior Associate Quality Assurance role, then please don't wait to apply!