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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