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Quality Assurance Manager

Company: Systematic Business Consulting
Location: New Brunswick
Posted on: June 22, 2022

Job Description:

SUMMARY In alignment with organizational goals, we are looking for a Quality Assurance Manager who will support in the development of the Quality department & in the day-to-day activities associated with Quality, Operations and Regulatory departments. The Quality Assurance Manager will oversee all Quality Audits - for Customers, Supplies & Regulatory Agencies (including but not limited to FDA, EPA, DEA, OSHA). This individual will ensure Spectrum's compliance in the timely compilation of reporting, responses, and communications with the agencies listed above. In this role you will:

  • Act as the Subject matter expert on all FDA regulations and requirements as well as the advisor to the senior management team; in addition to acting as the liaison for all regulatory agencies
  • Spearhead the company's Quality Assurance functions while building a team of likeminded individuals
  • Demonstrate a strong partnership with cross-functional teams, mainly Operations and QC
  • Act as the "go to" for audits and inspections (including readiness), as appropriate.
  • Maintain SCM's compliance with cGMPs
  • Manage Out of Specification investigations reports
  • Review product and process deviations
  • Review New product set up
  • Participate in the evaluation, selection service providers
  • Provide GMP, ISO, GDP training to the team
  • Manage ISO 9001 certification for SCM
  • Manage Quality Documentation process
  • Negotiate and maintain vendor Quality Agreements
  • Provides guidance to peers regarding Quality and regulatory issues.
  • Prepares and reviews annual reports and supplements for marketed products.
  • Accountable for Raw Material Change control program
  • Support SCM's Vendor Management initiative
  • Supervises the identification and compilation of required documentation for submissions.
  • Function as the quality lead for any assigned projects; providing support to the Operation, Quality Assurance units as needed.
  • Write/review and update Standard Operating Procedures
  • Independently prepare and submit meeting requests and meeting packages, leading all company quality and regulatory meetings.
  • Provides expert opinion, advice, and recommendations to the organization regarding quality processes.
  • Problem-solve quality issues to preserve original timeline for various projects; track progress while being accountable for quality system deliverables.
  • Accountable for maintaining the organizations adherence to all relevant Quality requirements.
  • Perform other duties as required, interfacing with other departments, customers and external vendors as needed.
  • Help drive a LEAN culture by mentoring and creating training opportunities. Internal quality system audit and remediation skills required.
  • Collect data, analyze outputs, and determine corrective courses of action to promote safety, quality, and efficiency
  • Identify ways to eliminate waste in production processes.
  • Analyze and identify opportunities to reduce process variation, improve process capabilities and optimize process performance.
  • Work with management to identify new process improvement opportunities in the areas of quality, cost, performance, and preventive and predictive maintenance.
  • In-depth experience implementing Lean, 5S, Value Stream Map and KaizenEDUCATION and/or EXPERIENCE:
    • Candidate must have a bachelor's degree from a four-year college, strong preference for a background in Chemistry
    • Minimum of 5 years' experience managing teams, building and managing a dynamic team
    • Minimum of 5 years' experience leading and managing Customer & Supplier Audits
    • Minimum of 5 years' experience leading and managing FDA/DEA/Regulatory inspection experience
    • Minimum of 5 years' experience in a GMP, GDP environment
    • Experienced in the investigation of OOS, Complaints, CAPAs, SCARs, Deviations
    • Experience in Change Control, Process Improvement, Lean, Project ManagementCERTIFICATES, LICENSES, REGISTRATIONS (Strongly Preferred):
      • LEAN Six Sigma Certification
      • ISO 9001:2015 Lead-Auditor Accreditation
      • GMP auditor

Keywords: Systematic Business Consulting, New Brunswick , Quality Assurance Manager, Executive , New Brunswick, New Jersey

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