Supervisor, Quality Assurance

Kindeva Drug Delivery•Brentwood, MO

1d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience at an aseptic manufacturing site preferred.
1 year of supervisory experience is preferred.

Responsibilities

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