Quality Assurance Manager

LocationBrookfield, Connecticut
Reports ToSite Quality Director
Position Overview

The Quality Assurance Manager is responsible for checking the implementation of the quality management system (QMS) including accordance with ISO 9001 and applicable cGMP requirements.  The role has the responsibility of representing Greenfield Global’s commitment to quality to our customers and/or regulatory bodies. The role must conduct quality assurance audits and monitor and record results from processes and procedures within the production and quality units.  Corrective measures are to be taken if any deviation from normal procedures is found.  This may include a deviation, NCR, etc. A major component of this role is the final QA verification of production and quality records and the management of production QA verifier.

Duties & Responsibilities
  • Responsible for completeness of documentation such as batch record and QC data prior to product release.
  • Responsible for the associated Quality Processes (i.e. Deviations, Product Quarantine, CAPA control, protocols, etc.) are progressed in a compliant and timely manner and ensure cGMP compliance is maintained.
  • Lead or participate in external audits from customers and /or regulatory bodies.
  • Manage customer complaints and inquiries related to the site QMS.
  • Provide Quality oversight for calibration and maintenance program.
  • Lead efforts for process and product risk assessments.
  • Manage the activities of the Quality Assurance department in a manner that keeps plant and senior management fully informed on any issues and assists in achieving quality and compliance goals.
  • Manage corporate food safety and quality programs and maintain the required documentation and provide continuing education of plant associates as required.
  • Acts a liaison for commercial, quality, and production personnel regarding product quality issues.
  • Conducts Internal Audits according to the established schedule to ensure HACCP and QMS are effectively implemented.
  • Identifies discrepancies in current practices, food safety and QMS requirements through quality audits, conduct root cause analysis, and facilitate development of corrective and preventive actions to resolve issues on continual basis.
  • Establish employee work schedules based on needs of internal customers.
  • Manage validation and qualification programs and final approval of commissioning documents.
  • Develop, write, and maintain protocols and reports.
  • Must acquire/maintain sufficient knowledge of manufacturing and QC processes.
  • Review and approval of batch records, product files and quality control data, and Certificates of Analysis for the purposes of product release.
  • Ensure site-based compliance for certifications on Organic, Kosher, ISO, and GMP
  • Confirming that any investigations and deviations associated with the product under review are resolved and closed.
  • Release of raw materials and finished goods for shipment and stock through ERP systems – such as Navision.
  • Manage a small team of Quality Assurance professionals.
Skills & Qualifications
  • Bachelor’s degree in chemistry or related science
  • Minimum five years of Quality experience, preferably chemical manufacturing
  • Supervisory experience
  • Excellent communication skills
  • ISO 2015 and cGMP implementation experience a plus
  • TTB and compliance experience preferred
  • Ability to foster collaborative, cross department relationships to meet common objectives
  • Possesses Company values of honesty, integrity, respect, commitment and openness to change while modelling the Company Core Principles in all activities.