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 Shift Lead will support the QC supervisor 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. He/she will monitor and control the daily activities of quality inspection, testing, documentation review. Carry out QC tasks/ inspections when required, to support the team. 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 escaladed 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 Associate's Degree in Technical or Engineering required or
- Bachelor's Degree Degree in Technical or Engineering preferred
Work Experience
- Minimum 5 years Previous experience in Quality Assurance/Quality Control required and
- Experience in FDA regulated environment, pertinent to ISO 13485 preferred and
Preferred Knowledge, Skills and Abilities
- Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Leadership experience in leading teams of 10-15 people preferred
License and Certifications
Travel Requirements
5%: Up to 13 business days per yearPhysical 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.
- Maintain high attention to detail, accuracy, and overall quality of work.
- Effectively communicate and interface with various levels internally and with customers.
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Performing the duties of this job involves the employee walking, standing on concrete floor, sitting for extended periods, lifting of cartons, containers, or bags of product, using hands and fingers to touch or feel materials or products, and listening for audible tones of equipment. This requires that the individual have normal hearing ability. The employee must be able to maintain concentration and visual acuity on tasks for extended periods.
- The employee must perform visual inspection of product, color standards, raw materials, and graphics. Specific vision abilities required to perform these tasks include close vision, color vision, peripheral vision, depth perception, and the ability to focus when viewing items through magnification. Required to work 40 hours a week and some overtime.
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 Apply.Accommodation@westpharma.com. 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 and/or a pre-employment drug screening.