Quality Auditor Supervisor

Description This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary In this role, the QC supervisor will be to ensure safe, compliant, and efficient operations in the Quality Control department. He/she will manage directly and closely support the quality inspectors in all areas. He/she will assist QC Manager to build-up a team of competent QC inspector to achieve consistent compliance and timely execution of tasks. Responsible for Safety, accountable for adherence to procedures, quality and schedules on assigned shifts; promote effective team member/Company relations to help improve team engagement, customer service and Company profits. Essential Duties And Responsibilities Supervise shift personnel in the quality control department consistent with high safety and quality standards. Troubleshoot problems arising on the shop floor in conjunction with quality standards with the appropriate engineering support from Quality Engineering functions. Maintain close observation of quality requirements to keep quality management informed of status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements. Promote and support site initiatives including quality safety programs, lean initiatives, training programs, and consistently interpret and apply all policies, practices and procedures among plant team members. Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency. Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues. Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked. Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions. Determine product acceptability by performing various types of inspections and measurements utilizing varying laboratory equipment and taking care of valid calibration (internal and external). Create, utilize, and maintain testing result forms. Develop sampling plans and activities, as required. Authoring of quality notifications such as deviations and OOS (visual and dimensional). Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system. Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations. Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence. Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner. Liaise with internal and external customers and other departments as appropriate. Ensure that the QC inspection conducted are performed according to relevant procedures and data reported in compliance with data integrity principles. Act as a central point of communication for all departments in respect to product quality issues on the shop floor and ensure that these are escalated appropriately. Other duties as assigned. Additional Responsibilities Participate in special project teams as assigned. Performs other duties as assigned based on business needs. Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions. Exhibits regular, reliable, punctual and predictable attendance. Education Associate's Degree in Technical or Engineering required Bachelor's Degree in Technical or Engineering preferred Work Experience 5+ years experience in regulated Quality Assurance and or metrology and Document/Configuration Control (or a formal education equivalent) required. Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Metrology/Manufacturing background and Risk Management preferred. Experience with quality systems such as ISO 13485 and 21 CFR 820 preferred. Experience with MasterControl, SAP, and SharePoint preferred. Experience with customer interface and meeting customer expectations preferred. 3+ years of supervisor experience preferred. Preferred Knowledge, Skills And Abilities Ability to work independently, multi-task and thrive in fast-paced environment. Excellent written and verbal communication skills. Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint. Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485. Familiarity with root cause analysis tools. Working knowledge of MasterControl and SAP. Support and contribute in Lean Sigma programs and activities towards delivery of the set target. Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members. Able to be aware of all relevant SOPs as per Company policy and Quality Manual. Able to comply with the company’s safety policy at all times. Travel Requirements 5%: Up to 13 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Additional Requirements Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events. Must maintain the ability to work well with others in a variety of situations. Must be able to multi-task, work under time constraints, problem solve, and prioritize. Ability to make independent and sound judgments. Observe and interpret situations, analyze and solve problems. Maintain high attention to detail, accuracy, and overall quality of work. Effectively communicate and interface with various levels internally and with customers. What We Offer Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities. Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives. Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively. Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion- where all voices are heard and respected in a supportive environment. Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact. Shift Monday through Friday. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to View email address on click.appcast.io . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening. #J-18808-Ljbffr RXinsider LTD.