Quality Assurance Manager - 1st Shift

Description

SUMMARY

Manages the overall direction, coordination, and evaluation of QA staff, develops and manages the company’s quality control environments to prevent internal failures. Develops initiatives to improve production performance against established quality measures, resulting in reduced product holds and customer complaints. Manages and mentors Quality Assurance personnel and acts as the primary liaison regarding quality with customers, vendors, and external regulatory agencies.

Implements a robust Quality Assurance (QA) program that includes a comprehensive Quality Management System (QMS), quality control and inspection, non-conformance tracking and assessment, risk analysis and assessment, problem/failure reporting, and process/equipment/software validation. Manages cGMP implementation and maintenance in all cGMP-related activities. This position will either work at NOW Health Group’s 395 manufacturing facility or at the Knollwood Corporate office.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Manufacturing Location Responsibilities:

• Manages all Quality Assurance activities for all production facilities, including, but not limited to, Document Control, Training, Compliance, and Quality Engineering.
• Develops, creates, revises, and approves raw material, in-process, finished product, and packaging component specifications. Develops and maintains Standard Operating Procedures. Reviews and qualifies new materials and vendors.
• Manages the compliance team including direct oversight of vendor and customer audits.
• Manages the training team that oversees New Hire Orientation and manages On-the-Job Training.
• Assists with the writing, review, and approval of Standard Operating Procedures (SOPs) and Master Manufacturing Records (MMRs), ensuring compliance with the company’s policies and FDA regulations.
• Assists with monitoring of daily audits of production procedures, including verification of code dates, scales, specifications, plant GMP’s, and documentation.
• Implements quality and process improvement initiatives in conjunction with quality and operations personnel to ensure products meet quality standards.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits, collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
• Ensures key performance indicators in the quality area are met or exceeded. Measures productivity on a daily basis, with the goal of meeting standards.
• Supports quality system deviations, CAPA, change control, environmental monitoring, etc. to support lot release and continuous improvement.
• Reviews and approves all levels of quality validations (equipment, process, and software), as needed.
• Assists Senior Management in plant process improvement activities and implementation for Quality systems investigation review and approval.
• Ensures quality systems comply with regulatory requirements.
• Ensures pre-requisite programs (pest control, environmental monitoring, etc.) are compliant with GMPs.
• Creates and revises written justification for procedures in relation to cGMP compliance.
• Supervises specification creation/revision for all NOW products and raw materials.
• As needed, accompanies group members on audits or site visits of contract manufacturers, if necessary.
• Maintains knowledge and communicate GFSI standard updates and FDA FSMA requirements and trends to senior management.
• Maintains and manages our audit certifications for all production facilities.
• Complies with safety and GMP requirements.

Corporate Office Responsibilities :

• Manages all Quality Assurance activities for all production facilities, including,…