Quality Assurance Manager

Spectrum Staffing Services/HRStaffers


Our client, a leading pharmaceutical ingredient distributor and manufacturer, is seeking a QA Manager to join their team. This global organization is offering a competitive benefits package and dynamic team driven environment! 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.


  • 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 SCMs 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 SCMs 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 Kaizen


  • Candidate must have a bachelors 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 Management


To apply, please visit the following URL:https://www.jobs2careers.com/click.php?jid=641c76c4d16da3ec9a6ab9965&ri=98b649438eea49c9b6dcddfaf1edad06&job_loc=Lawndale%2CCA&q=Spectrum&spl=5473444c336d76727a2b31784b4e68493a64464876794a59735355786a72716f433061324357513d3d3a59377231595236573869734a444b4e5268527a796f384c4e67415348485778456152793136744c6f707548545366516268456e30504863317036344132395379654234737a344942464f4d4d7768766d56444768416532507a6f6c70643451692f576c71305963686d6c384431736e4d5858704d573553342f68666f636e7578687a434f&encrypt=0&l=united+states→