11 September 2022
QA Specialist Supplier Auditor

QA Specialist Supplier Auditor
$55,000 per year
Direct/Hire Permanent Position
Pharmaceutical Manufacturing
Miramar, FL

 
Job Summary
The QA Specialist Supplier Auditor implements and oversees activities performed by Quality Assurance Material & Supplier Quality within the material qualification program to support the utilization of materials in Drug Substance and Drug Product Manufacturing.


Job Responsibilities
  • Conduct supplier audits on a regular basis to ensure suppliers and their supplies remain in compliance with company and federal manufacturing and production standards.
  • Communicate with suppliers regularly to address any concerns, improve performance, and foster an environment that facilitates continual improvement in working relationships.
  • Communicate with departments regularly to address any concerns, improve performance, and foster an environment that facilitates continual improvement in working relationships.
  • Perform investigation and analysis of supplier complaints and notification of changes.
  • Execute remote and onsite audits
  • Create, maintain, and distribute reports related to quality to upper management including identifying, reporting, and escalating relevant Quality issues to management.
  • Ensure CAPAs are performed per defined Quality / Business Corporate and Site Objectives / KPIs and Metrics.
  • Drive Compliance Lean Initiatives Author / write and review SOPs / documentation.
  • Compile and provide Compliance Quality Metrics on a monthly, quarterly and annual basis
  • Perform periodic facility walkthroughs to identify compliance risks before audits or inspections
  • Understand and interpret regulations and standards (i.e, including 21 CFR part 11)
  • Support review and disposition of incoming materials, and material qualification as required.
 
Job Requirements
Education
  • Bachelor's Degree in Scientific/ Pharmaceutical field of study or combination education, experience, and knowledge. Prefer 2-5 years of biopharmaceutical industry experience in Quality Assurance or Regulatory Affairs or an Associate's Degree with 3-5 years' experience in Quality Assurance; or an equivalent amount of education an experience.
  • Experience in cGMP, API drug development, ; Quality Agreements (internal/external customer and supplier relationships), and Global Regulatory Requirements preferred
  • Experience in GMP-regulated industries in Manufacturing Operations, Process Validation with Quality Systems knowledge
  • Knowledgeable of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices, validation principles, and applicable regulations.
  • Previous experience managing suppliers, Leading and performing audits (3 years), and performing investigations are required, as is prior knowledge of US and International cGMP regulations.
  • Previous experience with cGMP, CAPA, investigation process and regulated pharmaceutical/medical device industry practices.
Knowledge, Skills and Abilities
  • Strong knowledge of personal computer and databases such as MS Office, Word, Excel, and Power point.
  • Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility.
  • Experience managing investigation, CAPA process and writing Quality reports.
  • Demonstrated ability of having cross functional / team experience.
  • Communicates well.
  • Demonstrated Technical writing skills.
  • Ability to understand and follow operating procedures, in order to perform data entry and develop reports.
  • Must be able to effectively present information and respond to questions from management and/or peers.
  • Must be able to read, write, and speak English proficiently.
  • Ability to read, creates, and interprets charts.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Experience
  • Quality Assurance experience in the pharmaceutical or other regulated industry is required.
 
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