Overview
Quality Control Manager (Production Operations) Jobs in Conshohocken, PA at Extremity Care
Full Job Description
Purpose
The Quality Control Manager is responsible for managing execution of quality control activities to support production, which includes equipment maintenance/calibration, equipment qualifications, environmental monitoring, and deviation/nonconformance investigations.
Duties & Responsibilities
Manage and oversee technical review of HCT/P production records in accordance with standard operating procedures and regulatory requirements
Support scheduling and execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, and environmental monitoring
Support environmental trending data analysis
Support development and execution of equipment qualification protocols and summary reports in accordance with regulatory requirements and industry best practices
Identify and resolve equipment qualification issues and exceptions/deviations
Review and approve equipment qualification protocols, execution data, and summary reports to ensure accuracy, completeness, and compliance with established standards
Initiate change orders to document change requests and associated risk assessments
Initiate and conduct investigations for deviations, nonconformances, and CAPAs
Lead re-training driven by quality event corrective actions
Author/revise procedures according to FDA, AATB, and other applicable regulations
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and industry standards
File and maintain records in accordance with standard operating procedures
Manage direct reports
Establish and monitor objective annual goals for direct reports
Conduct performance reviews and establish performance improvement plans as needed
Recruit, interview, and select personnel for hire
Attend/participate in offsite business meetings/conferences
Report to work in-person and start job duties on time
Complete required hours on assigned work shifts to complete assigned responsibilities and duties properly
Attend all scheduled meetings and appointments
Perform other related duties as assigned
Skills & Abilities
Leadership & Management
Attention to Detail
Organized
Verbal/Written Communication
Analytical Thinking
Technical Writing
Multi-tasking
Education & Experience
Bachelor’s degree in a biological science or related field
At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience
Experience with audits to include FDA, ISO and internal audits preferred
Valid Class “C” drivers license
Title: Quality Control Manager (Production Operations)
Company: Extremity Care
Location: Conshohocken, PA
Category:
