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

• 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).