Quality Assurance Manager
Company: Systematic Business Consulting
Location: New Brunswick
Posted on: June 22, 2022
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
- 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
- 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
- Prepares and reviews annual reports and supplements for
- 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
- 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
- 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 &
- 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,
- Experience in Change Control, Process Improvement, Lean,
Project ManagementCERTIFICATES, LICENSES, REGISTRATIONS (Strongly
- 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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