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Quality Assurance Specialist

Quality Assurance Specialist

TRS Staffing SolutionsCharleston, SC, United States
2 days ago
Job type
  • Full-time
Job description

Position : Quality Assurance Specialist

Location : Charleston, SC

Shift : 2nd Shift | Monday – Friday | 3 : 00 PM – 11 : 00 PM

Compensation : $65,000 – $85,000

Benefits : Full Benefits Package | Paid Time Off | 401(k) | Relocation Assistance Available

Overview

We are seeking a detail-oriented and experienced Quality Assurance Specialist to join our team in a sterile manufacturing environment. This role is critical to ensuring compliance with cGMP standards and maintaining the highest levels of product quality and data integrity. The ideal candidate will have hands-on experience in sterile manufacturing, environmental monitoring, and quality documentation processes.

Key Responsibilities

  • Perform quality review and approval of deviations, investigations, batch records, protocols, and reports.
  • Conduct floor audits and inspections to ensure compliance with GDP and data integrity standards.
  • Support client and regulatory audits, providing documentation and insight as needed.
  • Oversee the release of support materials, products, equipment, and facilities.
  • Maintain and analyze quality databases; identify trends and improvement opportunities.
  • Develop and revise SOPs and other quality documentation.
  • Provide training and consultation on quality and compliance topics.
  • Ensure timely and accurate completion of all cGMP and company training requirements.
  • Actively contribute to the site’s Quality Management Systems (QMS), including investigations, CAPAs, and change controls.

Qualifications

  • (Preferred) Bachelor’s degree in Chemistry, Biology, or a related field with 3+ years of relevant experience, or a Master’s degree with 1+ year of experience.
  • Demonstrated experience in GMP-regulated environments.
  • Preferred experience in environmental monitoring and critical utilities within sterile operations.
  • Strong understanding of GDP, data integrity, and quality assurance processes in manufacturing.
  • Skills & Competencies

  • Proficient in Microsoft Office and CRM tools (e.g., Salesforce, HubSpot).
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and collaboratively across teams.
  • Comfortable interacting with clients, regulatory agencies, and internal stakeholders.
  • Ability to mentor and train others on quality and compliance topics.
  • Work Environment & Physical Demands

  • This is a 100% on-site role.
  • May require standing, walking, sitting, and lifting up to 50 lbs.
  • Occasional exposure to mechanical parts, elevated workspaces, and vibration.
  • Must wear appropriate PPE, including safety eyewear, respirators, lab coats, and gloves.
  • Noise levels may vary depending on the work area (lab, manufacturing, office).
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    Quality Assurance Specialist • Charleston, SC, United States

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