QA Inspector - 3rd Shift

Kindeva Drug Delivery

Our Work Matters

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

The Impact You Will Make

The QA Inspector - Aseptic will be able to audit aseptic processes for conformance to established specifications, procedures, cGMPs, and FDA regulations and identify any non-conformances.  This position requires excellent written and oral communication and the ability to work effectively across multiple departments to achieve initiatives.  The incumbent must be able to work well with personnel at all levels throughout the organization including peers, operations personnel, supervisors, and managers. This role requires the ability to perform job related tasks at a high level independent of direct supervision.

Role Responsibilities

• Communicate non-conformances found during aseptic processing operations to the QA Manager / Supervisor on shift.
• Follow established procedures and identify gaps as written, update procedures as needed.
• Ensure adequate coverage for APA and Grade D/CNC areas throughout the shift.
• Lead monthly In Process Batch Record Review.
• QA Floor point of contact to QA and Production Management.
• Train Floor Quality Assurance colleagues.
• In-process review of production batch records for accuracy of documented entries and conformance to established procedures.
• Perform inspection readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities.
• Must be able to complete aseptic gowning qualification and work daily in a Grade A/B classified area.
• Understand and demonstrate aseptic techniques and behavior required in aseptic processing areas.
• Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues.
• Initiate event(s) in QTS per SOP-QLA-MQA-00720, as applicable.
• Perform PRISM transactions, as applicable.
• Must be willing to work overtime to support business initiatives.
• Weekend hours (Saturday and/or Sunday) are required.

 Basic Qualifications

• High School degree required
• The ideal candidate will possess a combination of relevant education, aseptic training and manufacturing/quality
• Minimum of 3 years of related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience is recommended.

Preferred Qualifications

Bachelor's degree in a scientific discipline is preferred.

 NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• 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, 3rd shift, and hours outside defined shift.
• Must be able to gown aseptically.

This is a 3rd shift position, Monday- Friday 10:00pm-6:30am.

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