Title: QA Specialist II - Quality Systems
Summary: A global biopharmaceutical company is currently seeking a hardworking and reliable QA Specialist II - Quality Systems to join their new Canton, MA plant. You will cross-functionally support investigations and quality documentation, provide QA oversight of each Quality System to align with commercial product manufacturing, and aid the CAPA, Change Control, and Risk Management programs. Do you want to be a part of therapeutics that help protect people's lives? If yes, please reach out to learn more.
The QA Specialist II - Quality Systems will be responsible for…
- Owning and managing the deviation quality system process and on-site Risk Register Program
- Preparing functional and management review metrics for identification of negative trends and conducting analysis to propose and implement necessary corrections
- Leading or participating in cross-functional teams to address facility issues through methodical problem-solving to analyze issues, determine root causes, identify appropriate corrective and preventive actions, and assess product impacts
- Timely performing complaint investigations as required by QA management
- Conducting SOP generation, review, and/or approval
The QA Specialist II - Quality Systems should have the following qualifications:
- Bachelor's Degree or equivalent combination of education and work experience
- Expert knowledge and application of GMP principles
- 8 years of cGMP Quality experience, including in cGMP manufacturing facility
- Experience reviewing, writing, and leading deviations, CAPAs, and Change Controls
- Exposure to US, EU, and Canadian pharmaceutical regulations, and ISO standards
The firm offers benefits and programs aimed at helping you improve and prioritize your own health, work-life balance, and financial stability.
- Health and wellness initiatives based on employee interest
- Flexible hours program
- Identity protection and 401(k) retirement plans
If you are interested in the QA Specialist II - Quality Systems role, then please don't wait to apply!