Manager - Quality Assurance - Port Jervis Quality Salary Indirect

KDC One•Port Jervis, NY

About The Position

Summary: The position requires skills necessary for auditing, writing investigations, non-conformance reports, corrections, corrective actions, and document control updates. The ideal candidate must understand and implement all cGMP and other related regulatory requirements. Essential Duties and Responsibilities: Ensuring all non-conformance investigations are complete, are properly closed out, and documented as per procedure, ensuring overall procedural compliance. Participates in the site Internal Audit program and external regulatory and customer audits. Reports on audit findings, assigns findings to area owners, and tracks and facilitates the closure of findings in a timely manner. Trends complaints, non-conformances, investigations, and laboratory OOS investigations, providing explanation for the significant trends, and calling out when action is required to improve trends. Manages multiple tracking spreadsheets and communications with assigned owners. Creates and updates procedures, work instructions, forms, and job aids, when required. Lead investigation and resolution of issues; define problems, identify root causes, and implement corrective and preventive actions. Facilitate customer audits and lead corrective/preventive actions to address findings. Drive improvements to company systems, processes, and procedures to resolve and prevent issues related to specifications, validations, manufacturing, and product release. Provide Quality leadership; make and guide decisions that ensure products meet customer and regulatory requirements. All other duties as assigned.

Requirements

BA/BS degree in a science related field preferred.
Minimum of 2 years working in a Quality role in a manufacturing environment.
Excellent problem solving, analytical, oral, and written communication skills.
Strong investigative skills.
Good organizational skills with the ability to multi-task.
Knowledge of cGMP practices, of quality laboratory practices and processes, and current FDA guidelines.
Demonstrates attention to detail.
Display high standards of ethical behavior.
Works with minimal supervision.
Skilled in the use of computers, particularly word processing software.
Flexible to constantly changing priorities
Demonstrated ability to manage multiple projects simultaneously and set priorities.
Team oriented with excellent written and verbal communication skills.

Nice To Haves

ASQ CQE (American Society for Quality, Certified Quality Engineer (desirable)

Responsibilities

Ensuring all non-conformance investigations are complete, are properly closed out, and documented as per procedure, ensuring overall procedural compliance.
Participates in the site Internal Audit program and external regulatory and customer audits.
Reports on audit findings, assigns findings to area owners, and tracks and facilitates the closure of findings in a timely manner.
Trends complaints, non-conformances, investigations, and laboratory OOS investigations, providing explanation for the significant trends, and calling out when action is required to improve trends.
Manages multiple tracking spreadsheets and communications with assigned owners.
Creates and updates procedures, work instructions, forms, and job aids, when required.
Lead investigation and resolution of issues; define problems, identify root causes, and implement corrective and preventive actions.
Facilitate customer audits and lead corrective/preventive actions to address findings.
Drive improvements to company systems, processes, and procedures to resolve and prevent issues related to specifications, validations, manufacturing, and product release.
Provide Quality leadership; make and guide decisions that ensure products meet customer and regulatory requirements.