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Quality Assurance Specialist

Clarence, NY

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Description

Quality Assurance Compliance Specialist/  Clarence, NY/1st and 2nd Shifts

 

An established and growing Clarence, NY Manufacturer is looking for a Quality Assurance Compliance Specialist to support Quality Assurance activities at the facility!

 

 

Shift:

1st shift 7AM-3:30PM

2nd shift (2:00p-10:30p) with initial training on 1st shift (7-3:30 Monday thru Friday with occasional Saturdays possible.

 

Responsibilities:

  • Performing Acceptable Quality Limits (AQL) inspections during daily manufacturing and labeling processes in accordance with cGMPs and internal procedures
  • Providing compliance review of general quality system elements (e.g., change control, work orders, working documents, logbooks)
  • Overseeing that processes are in cGMP compliance and establish systems that identify opportunities for continuous improvement
  • Supporting Discrepancy Investigations, Corrective and Preventive Actions (CAPA), Effectiveness
  • Checks, Internal Auditing and Complaints
  • Initiating or executing Action Plan requirements as needed to address investigation or compliance related activities
  • Participating in investigations as needed to address problems and assist in resolution
  • Completing  gowning qualification and maintaining status for entry into Aseptic processing area
  • Working closely with manufacturing personnel to meet the needs of operations
  • Ensuring good manufacturing and documentation practices

 

Requirements:

  • Knowledge of GMPs, documentation processes/requirements
  • Minimum of a high school diploma; Associate degree from accredited college/university preferred
  • Minimum of 2 to 5 years of related experience in a regulated environment
  • Knowledge of current office software (e.g., Microsoft Word, Excel, Outlook, etc.)
  • Experience in electronic control systems (e.g., Mastercontrol)
  • Good verbal and written communication skills

 

Great opportunity with an established and rapidly growing Clarence Manufacturer! Apply today! 

Military Veterans encouraged to apply!

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