Quality Assurance Supervisor

1 week ago


Scottsdale, Arizona, United States West Pharmaceutical Services Full time
Job Summary

This position is a night shift role, working Sunday, Monday, Tuesday, 5:30pm to 5:30am and every other Wednesday. The successful candidate will be responsible for monitoring and controlling the daily activities of quality inspection, testing, and documentation review, in support of Operations and product release.

Key Responsibilities
  • Supervisory Duties: Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs supervisory discipline as necessary.
  • Team Development: Facilitates the growth and development of direct reports by providing guidance, training, and mentorship.
  • Process Improvement: Implements strategies to build team cohesion, enhance skill sets, and foster a collaborative and productive work environment.
  • Quality Assurance: Exhibits a strong 'quality first' mentality and ensures that product and process quality are held to the highest standard.
  • Compliance: Ensures compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.
  • Scheduling: Schedules and prioritizes quality inspection, testing, and documentation review to support Operations and release of product.
  • Process Optimization: Identifies and develops opportunities to improve existing processes and procedures.
  • Quality Assurance Improvement: Supports quality assurance improvement activities by evaluating products, processes, or materials in order to develop control of or improvement strategies intended to improve the customer's experience.
  • Root Cause Analysis: Works with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
  • Quality Inspection: Assists in and manages the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensures proper corrective actions, discrepancy reports, and follow-up activities are accomplished. Advises on equipment condition, test method, etc. to aid in action when components do not meet specifications. Responsible for quality inspection and verification.
  • Documentation Review: Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if a Non-Conformance Report is required.
  • Non-Conformance Management: May own Non-Conformances, Audit Findings, CAPAs, CAPA Actions, Issue Review, and Deviations.
  • Documentation Development: Assists in developing documentation and procedures during the qualification of new equipment/inspection methods.
  • Additional Responsibilities: Performs other duties as assigned based on business needs. Creates and monitors KPIs relating to Quality Control. Conforms with and abides by all regulations, policies, work procedures, instructions, and all safety rules. Exhibits regular, reliable, punctual, and predictable attendance.
Requirements
  • Education: Bachelor of Science in a related field or equivalent.
  • Experience: 5-8 years of experience, with 5+ years of supervisor experience.
  • Preferred Knowledge, Skills, and Abilities: Metrology Equipment experience, ISO 1345 experience, Technical writing experience, Goals and objective setting experience, Sampling plan experience (statistical), Incoming, In-Process, and Finished Goods batch release experience, Root Cause Analysis and problem-solving experience, Change control experience, Awareness of all relevant SOPs as per Company policy, Support and contribute to Lean Sigma programs and activities towards delivery of the set target, Ability to comply with the company's safety and quality policies at all times.
  • Travel Requirements: Must be able to travel up to a minimal amount of time.
  • Physical and Mental Requirements: Light – exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects. Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.


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