Quality Assurance Specialist

5 days ago


Marquand, Missouri, United States Harba Solutions Inc. Full time
Job Title: Quality Assurance Specialist

At Harba Solutions Inc., we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance across our supply chain.

Responsibilities:
  • Supplier Management: Manage and maintain the certified supplier list, ensuring all records are current and aligned with quality risk assessments.
  • Regulatory Compliance: Ensure compliance with operational standards from US and international regulatory agencies, including FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, and cGMP.
  • Audit and Compliance: Act as the site auditor for suppliers, ensuring adherence to audit schedules and quality standards.
  • Change Control: Lead and manage the supplier change control process, handling notifications and changes.
  • Quality Investigations: Investigate and resolve quality issues, including non-conformances, out-of-specifications, and deviations, ensuring corrective actions are implemented effectively.
  • Regulatory Support: Provide regulatory support during FDA and other agency on-site audits.
  • Quality Expertise: Serve as the site's Quality Subject Matter Expert (SME) on MSD (Manufacturing Site Division).
  • Audit Coordination: Coordinate and oversee internal and external supplier audits to ensure quality and compliance across the supply chain.
  • Document Review: Review and approve quality-related documents, including validation protocols, certificates of analysis, and test reports.
  • Training and Development: Provide training and guidance to staff on quality systems and compliance procedures, fostering a culture of quality awareness throughout the organization.
Qualifications:
  • Education: Bachelor's degree in Biology, Chemistry, or a related field.
  • Experience: Minimum of 3 years of relevant industry experience, with a preference for experience in exception investigations and out-of-specification resolutions.
  • Skills: Strong ability to conduct Root Cause Analysis, resolve conflicts, and make decisive, effective decisions under pressure.
  • Software Proficiency: Proficiency in Microsoft Office Suite and other relevant computer programs for data entry and reporting.
  • Communication: Excellent verbal and written communication abilities, with the capacity to work independently or collaboratively as needed.
  • Knowledge: Thorough working knowledge of cGMP guidelines, with proven application in a pharmaceutical manufacturing environment.


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