Quality Control Manager (Production Operations) Position Available In Montgomery, Pennsylvania

Quality Control Manager (Production Operations)

Extremity Care Conshohocken, PA Job Details Full-time Estimated:

$82.9K – $101K a year 9 hours ago Qualifications Biology Management 5 years Bachelor’s degree Senior level Leadership Communication skills FDA regulations 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