Quality Control Supervisor II
Employment Type: Full-Time
Add to favorites Favorited View favoritesSupervise the quality control team and manage quality control functions, including inspection testing for raw materials. Chromatography resins, buffers, dyes and raw materials produced or used at the Bio-Rad chemical production plant.Responsibilities* Manages the maintenance and calibration of analytical equipment including the FTIR, HPLC, Gas Chromatography.* Provide leadership, direction and development to the plant's Quality Control personnel. Set expectations and hold employees accountable for performance and professional behavior. Provide guidance and conduct performance reviews.* Ensure a disciplined approach to quality procedures and work processes upholding Good Documentation Practices. Write/review/approve QC Procedures* Write clear and concise reports* Oversee quality assurance programs and engage with subject matter experts as appropriate. This includes managing Quality Notifications, Change Control Documents, SAP transactions, product blocks, usage decisions, and releases, batch record reviews, approvals, etc.* Direct interface with customers during audits providing requested documents, explaining programs and work processes.* Manage the plant's Quality Control budget. Manage procurements and department invoice processing.* Coordinate contract support and leveraged resources as needed for instrument maintenance* Conduct and participate in root cause failure analysis. Drive corrective actions* Interact with site, business, and corporate personnel to share information, collaborate and ensure stakeholder needs are understood. Represent the quality control function in the daily meeting and provide status updates.* Ensure appropriate training is provided to all quality personnel on programs/procedures and new equipment* Drive improvements in housekeeping and implementation of a 5S program* Develop and use visual management for metrics and work execution* Develop presentation and lead the monthly Quality Meeting. Provide statistical analysis summary and product performance trending.* Participate in plant leadership teams and appropriate committees* Support cross-functional departments to drive continuous improvement efforts.* Other duties and projects as assignedQualifications* Bachelor's degree or equivalent in a related field, preferably chemistry.* 6+ years quality control or manufacturing experience.* 3-5 years of supervisory experience.* Strong technical and analytical skills required.* Strong communication, public-speaking, decision-making, MS Office, and negotiation skills.* Background in statistical analysis and process capability studies-a plus.* Familiarity with SAP or similar ERP systems a plus.* Understanding of ISO 13485, FDA regulations, GMP and GLP required.* Excellent time management skills and ability to work both independently and in a team environment.* Direct supervisory experience of exempt or non-exempt employees.* Strong customer orientation and focus.About Bio-Rad:Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/AgeAgency Non-Solicitation:Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.