Job Description

Position Overview: The Quality Assurance Specialist will play a key role in ensuring the quality and compliance of our products/services through the implementation and maintenance of robust quality assurance processes and procedures. Reporting to the Quality Assurance Manager, the Quality Assurance Specialist will be responsible for conducting root cause analysis, implementing corrective actions, writing standard operating procedures (SOPs), reviewing batch records, and providing support for audits and inspections. The ideal candidate will have a strong background in quality assurance, exceptional attention to detail, and a commitment to upholding quality standards and regulatory requirements.

Key Responsibilities:

  • Conduct root cause analysis to investigate deviations, non-conformances, and quality issues, identifying underlying causes and contributing factors.
  • Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs) to address identified root causes and prevent recurrence of quality issues.
  • Write, review, and revise standard operating procedures (SOPs) to ensure clarity, accuracy, and compliance with regulatory requirements and industry standards.
  • Review batch records and manufacturing documentation to verify compliance with established procedures, specifications, and quality standards.
  • Provide support for internal and external audits, inspections, and customer audits, including preparing documentation, facilitating audit activities, and addressing audit findings.
  • Maintain documentation related to quality assurance activities, including CAPA records, SOPs, batch records, and audit reports, ensuring accuracy, completeness, and traceability.
  • Participate in cross-functional teams to support continuous improvement initiatives, quality risk assessments, and process optimization projects.
  • Assist in the development and delivery of quality-related training programs for employees, ensuring understanding and adherence to quality standards and procedures.
  • Stay current with regulatory requirements, industry trends, and best practices in quality assurance, and apply knowledge to drive continuous improvement and compliance.
  • Communicate effectively with internal stakeholders, including quality assurance, manufacturing, engineering, and regulatory affairs teams, to ensure alignment on quality objectives and priorities.

Qualifications:

  • Bachelor’s degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline; advanced degree preferred.
  • 3+ years of experience in quality assurance roles within a regulated industry, such as pharmaceuticals, biotechnology, or food manufacturing.
  • Strong knowledge and experience in root cause analysis, corrective action implementation, and CAPA management.
  • Proven ability to write, review, and revise standard operating procedures (SOPs) and batch records.
  • Experience supporting internal and external audits, inspections, and regulatory submissions.
  • Familiarity with quality management systems (QMS), regulatory requirements (e.g., FDA, ISO), and industry standards (e.g., cGMP, GLP).
  • Detail-oriented with exceptional analytical and problem-solving skills.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and document management systems.

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Job #:
27103908
Position Type:
Direct Placement
Location:
Rock Hill, SC
Flexibility:
Onsite

 
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