Quality Assurance Specialist - 2nd shift

Quality Assurance Specialist - 2nd shift Job Overview **Location** United States, North Charleston, South Carolina 1.

**Job skills** QA/QC 2.

**Type** Permanent **Job id** 164432 **Salary** Negotiable Apply Danielle Counihan I manage this role You are subscribed to our push notifications, but not currently for jobs like this.

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**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). TRS Staffing Solutions are an equal opportunities employer, and we welcome you to provide OFCCP data voluntarily here ( We are an equal opportunity employer.

All qualified individuals will receive consideration for employment without regard to race; color; age; sex; sexual orientation; gender identity; religion; national origin; disability; veteran status; genetic information; or any other criteria protected by governing law.