West Pharma Quality Auditor Supervisor 

United States, Arizona, Tempe 

57546891

In this role, you will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. This role is on-site (Monday through Friday) from 10:00 pm to 6:00 am.

• Able to train, provide trouble shooting guidance/feedback, and problem resolutions on metrology equipment including but not limited to CMM’s (Coordinate Measurement Machine), Vision Systems, and manual gaging.
• Proactively analyze data and interpret results for any trending or OOS (out of specification) events.
• Provides direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize quality inspection, testing, documentation review, and calibration to support Operations and release of product.
• Identifies and develops opportunities to improve existing processes and procedures.
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Assist in and manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished. Advise on equipment condition, test method, etc. to aid in the course of action when components do not meet specifications. Responsible for quality inspection and verification.
• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non‐Conformance Report is required.
• Assist in developing documentation and procedures during the qualification of new equipment/inspection methods.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance .

Education or Equivalent Experience: Associate’s Degree in Technical or Engineering

• 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.

• 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.

• 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.