Supervisor, Quality Assurance; 2nd Shift

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

QA Supervisor – Aseptic, will be primarily based at the Sterile Product Manufacturing (SPM) building and will provide general oversight to Quality Inspector colleagues. The ideal candidate will possess a working knowledge of aseptic processing principles including aseptic behaviors, good documentation practices (GDP), good manufacturing practices (GMP), facility controls and compliance / regulatory requirements relating to aseptic processing. The incumbent will facilitate timely resolution and escalation of all manufacturing deviations and effectively communicate deviations to Production and QA Management.

• Proficiency of internal manufacturing and quality assurance procedures as well as compliance and regulatory requirements.
• Proficiency in Batch Record reviews for conformance to established procedures and critical process parameters.
• Provide leadership and guidance to quality inspectors and ensure adequate coverage through dynamic scheduling for APA and Grade D/CNC areas throughout the shift.
• Ensure training is completed for direct reports
• Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues.
• Ability to solve problems and suggest solutions when escalating.
• Ability to successfully don a sterile gown and complete gowning qualification requirements and maintain it to support critical aseptic processing areas (APA).
• Participate in media fills as Quality Observer when needed.
• Initiate incidents in QTS as applicable.
• Train on performing line clearance / verification of critical areas.
• Perform daily on-line auditing in the APA to ensure the area is maintained in an audit ready state.
• Aid in Root Cause Analysis and identification of Preventive Actions to support manufacturing investigations.
• Assists in identifying continuous improvements of Standard Operating Procedures (SOPs) and Master Batch Records.
• Perform other Quality Assurance functions as needed.
• Attend and participate in daily shift huddles/Gemba meetings

• Education:
  
  BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science related discipline. In lieu of a bachelor’s degree an associate’s degree with 2+ years of experience.
• Experience:
  
  Minimum 3 years of pharmaceutical experience or equivalent combination of education and experience.
• Experience at an aseptic manufacturing site preferred. 1 year of supervisory experience is preferred.
• Produces quality work with minimal guidance.
• Must be able to work in a team environment and across interdepartmental teams.

• Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short, or long term basis.
• Must have the ability to simultaneously multi-task across multiple capabilities, functions and manages competing priorities, including performing site and functional responsibilities, frequent e-mail and phone communications and attending multiple meetings and conference calls.
  
  Note:
  
  these activities may not be time bound to core hours or presence at the site.
• Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.

This is a 2nd shift position, 2pm-10:30pm, Monday through Friday.

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