Quality assurance serp_jobs.h1.location_city

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