Sr Assoc, Quality Control

West Pharmaceutical Services • St. Petersburg, FL

23h • Onsite

About The Position

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.

Requirements

• HS Diploma required
• Minimum 3 years Previous experience in Quality Assurance/Quality Control required
• Experience in FDA regulated environment, pertinent to ISO 13485 preferred
• 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
• 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

Nice To Haves

• Associate's Degree in related field preferred
• Leadership experience in leading teams of 10-15 people preferred

Responsibilities

• Lead 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 dimensionnal)
• 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
• 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

Benefits

• benefit programs
• lifelong learning, growth and development
• empower the physical, mental, emotional and financial health of our team members and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED