Senior Quality Assurance Manager

Employment Type: Full-time Available Positions: 1 Location: On-SiteApplication Deadline: April 26th, 2024 Summary The Senior QC Manager will be responsible for performing and managing quality control-related activities to ensure product quality and compliance are maintained during the incoming of raw materials through manufacturing, packaging, and testing of medical devices Key Activities Manage a team of QC managers and supervisors for the production site to ensure consistent, quality materials are produced.Provide quality oversight of manufacturing activities daily and provide oversight on the review and approval of raw material and finished product releases including DHRs.Responsible for reporting Specifications and Deviations to QM management and perform root cause investigations and corrective actions as necessary.Manage the review and disposition of non-conforming material and customer-returned material, including rework, scrap, and return to vendor.Establish, monitor, and improve critical KPIs in the QC lab related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing.Monitor all stages of manufacturing operations to ensure strict compliance with cGMP/SOPs.Ensure all production and QC testing data is recorded in real-time.Recommend and support the implementation of continual improvement opportunities.Provide training to new associates according to the company SOPs as applicable.Write/update SOPs as needed about Quality Control operations in Production environment.Ensure that all data is organized and archived per appropriate workflows and SOPs.Support Internal Audit program and regulatory audits.

Preferred Skills Strong interpersonal and written/verbal communication skillsAbility to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities Educations & Experience

Bachelor’s degree with 7+ years of experience in a GMP regulated Pharmaceutical/ Medical Device/Nutraceuticals industry, with 3 + years in a managerial role.Minimum of 10 years of experience in good working knowledge of ISO/FDA regulations. Are you looking for your next opportunity? We can help. Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible. TQR is an equal opportunity employer that encourages diversity. We will consider all applications. Accommodation for applicants with disabilities is available upon request. Are you looking to hire? Get started here:https://www.topqualityrecruitment.com/fill-a-position/ See hiring advice: https://www.topqualityrecruitment.com/blog/ See all available opportunities: https://www.topqualityrecruitment.com/jobs/ We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application. Job ID: 7206