Actalent Quality Control Technician in Franklin, Massachusetts
Responsible for quality system processes designed to ensure continuous flow of incoming and outgoing materials consistent with established standards and regulations including FDA 21 CFR 820, ISO 13485, and appropriate EU regulations. Ensures compliance in QC areas including review and generation of information for incoming materials and product release. Ensures compliance in the areas of equipment qualification and calibration, supplier qualification and management, and document control as needed. Ensures continued improvement and compliance with relevant FDA, ISO 13485, and EU regulations by participating in audit responses, and deviation, nonconformance, complaint, and CAPA processes as necessary. Promotes and participate in training activities related to the quality management system and product quality, safety and efficacy.
• Responsible for performing final QC checks on all outgoing product shipments, which includes reviewing and assuring accuracy of both documentation and product.
• Responsible for release of incoming materials, manufactured materials, and finished products according to written specifications.
• Assist with the maintenance of the equipment qualification and calibration program and upkeep of the equipment database.
• Assist the QA/QC Manager with review and filing of calibration certificates, out of tolerance reports, deviations, and SCARs as necessary.
• Assist with the development and implementation of company SOPs as assigned.
• Perform document control and training activities as assigned.
• Requires an ability to complete cGMP documentation accurately, in accordance with standard operating procedures, and in a timely manner.
• Requires an ability to work independently to accomplish given tasks within given timelines.
• Requires an ability to multitask and adjust to changing priorities.
• Must report any deviations or nonconformities immediately to a Manager or Director.
Additional Skills & Qualifications:
Requirements: Associates/Bachelors in Scientific Discipline GMP knowledge (not experience), and importance of data accuracy for customer/vendor approval Basic lab skills and understanding of start up/shut down procedures Minimum Requirements/Qualificat
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
- Actalent Jobs