Quality Assurance Supervisor

Supervisor QA Kearney

This Full-time onsite role will be supervising coordinating and administering the site Quality Control systems compliance: Document Control Nonconformance/ Deviation Reports OOS Process Measurement Systems Change Control Calibration and CAPAs. Supervise and support internal projects and ensure cGMP compliance applicable ISO requirements company policies and procedures.

Essential Duties and Responsibilities

• Qualify inspectors to independently perform responsibilities for competency/ proficiency capabilities in inspections measurements sampling Quality audits and defect recognition.
• Qualify and/or support qualification of team members for competency/proficiency in defect and quality incident recognition/escalation.
• Train inspectors in deviation/non-conformance/OOS record initiations escalations how to perform containment/bracketing and initial event triage activities.
• Ensure deviation/ nonconformance reports and OOSs are completed properly including root cause investigation (if required) effective corrections and actions closed within an established goal.
• Monitor and enforce compliance to a high level of work standards across the QC functions. Ensure that jobs are carried out efficiently. Paperwork is maintained accurately in accordance with Company policies Regulatory standards and Training.
• Perform various SAP transactions for maintaining proper product disposition for release criteria and inventory control.
• Analyze data and provide reports/ recommendations to Management for continuous improvement.
• Submit periodic reports on the status of compliance to Quality System requirements.
• Review Customer specifications and ensure requirements are translated into site procedures and documentation as needed.
• Provide for Quality planning by preparing inspection plans and documentation controls.
• Support facilities equipment and process validations. Approve engineering studies and other protocols as required.
• Ensure proper completion of Change Controls and monitor timely completion when required.
• Monitor completion of MSAs for critical measurement systems and provide recommendations for gauging improvements.
• Provide expertise and guidance for statistical methods in Production.
• Conforms with and abides by all regulations policies work procedures instructions and all safety rules.
• Performs other duties as assigned based on business needs.
• Exhibits regular reliable punctual and predictable attendance.
• Other duties as assigned

Education

• Highschool Diploma required.
• Bachelors degree in Quality Engineering Science or equivalent experience preferred.

Work Experience

• Minimum of 3 years of related experience analyzing information documentation skills promoting process improvement and safety management.
• Minimum 1 year of leadership experience or demonstration of leadership skills routinely as part of previous/current role(s)

Preferred Knowledge Skills and Abilities

• Demonstrate a high degree of proficiency in Excel Word and other Microsoft Office Programs required. Demonstrate oral and written communication skills.
• Familiarity with a variety of Quality concepts practices AQL sampling plans for attribute and dimensional inspection. Demonstrate ability to investigate problems and issues in order to determine root cause analysis.
• Familiarity with GMP/GDP Regulations
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to make independent quality decisions under pressure if necessary
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the companys safety policy at all times
• Able to comply with the companys quality policy at all times

Physical and Mental Requirements

• Manufacturing environment requires strict adherence to standards. Working environment is a manufacturing facility and must be able to tolerate fumes and particulate generated from the processes.
• Work areas are equipped with adequate lighting cooling/heating and equipment that are in a good working condition.
• Must work constructively in an environment that may have competing resources while maintaining company confidentiality.
• Must be able to work scheduled work week plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other facilities when necessary.
• Must have good visual acuity. If specifically necessitated by customer requirements must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.

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.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
  
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Travel Requirements

Shift

1st Shift Position with occasional adjustments to accomodate 2nd/3rd shift interactions