Quality Assurance Specialist

Quality Assurance Specialist – Lancaster, SC
Salary: $60,000–$70,000 + bonus
Schedule: Monday–Friday | 8:30 AM–5:00 PM
Terms: This is a direct placement role with a full benefits package + paid end-of-year leave December 24 – January 2

Position Overview
We are seeking a detail-oriented and motivated Quality Assurance Specialist to support quality operations within a manufacturing and packaging environment in Lancaster, SC. This direct-hire opportunity is ideal for a quality professional with experience in GMP-regulated pharmaceutical or dietary supplement manufacturing who is passionate about compliance, continuous improvement, and product quality.

The Quality Assurance Specialist will support daily QA activities, including documentation review, non-conformance investigations, CAPA tracking, batch record review, and collaboration with Contract Manufacturing Organizations (CMOs). The successful candidate will work closely with Quality and Manufacturing teams to maintain compliance with current Good Manufacturing Practices (cGMP), internal procedures, and applicable regulatory requirements.

Key Responsibilities

• Provide in-process quality reviews and training to production operators.
  

• Support QA activities and quality processes involving Contract Manufacturing Organizations (CMOs).
  

• Assist with quality metrics, trending, and continuous improvement initiatives.
  

• Support Qualityze functions and utilize SAP quality functions as needed.
  

• Create and revise SOPs, batch records, process changes, and other GMP documentation.
  

• Conduct non-conformance investigations and support root cause analysis.
  

• Monitor non-conformance reports (NCRs) and Corrective and Preventive Actions (CAPAs) to ensure timely completion and prevent recurrence.
  

• Review and release CMO batch records and assist with internal batch releases.
  

• Identify and help correct documentation deficiencies in accordance with cGMP, company SOPs, CMO procedures, and applicable global regulations.
  

• Collaborate effectively with cross-functional teams to support quality and business objectives.
  

• Maintain reliable attendance and perform additional duties as assigned.

Qualifications

• High school diploma or GED required.
  

• Four years of experience in pharmaceutical or dietary supplement manufacturing preferred.
  

• Working knowledge of cGMP requirements in a regulated manufacturing environment.
  

• Experience with quality documentation, investigations, audits, or troubleshooting preferred.
  

• Strong attention to detail, critical thinking, and analytical skills.
  

• Excellent communication and interpersonal skills, with the ability to work effectively across all organizational levels.
  

• Ability to work independently while contributing to a collaborative team environment.
  

• Proficiency in Microsoft Excel, Word, and Outlook preferred.
  

• Familiarity with SAP, Qualityze, LIMS, or similar quality management systems is a plus.
  

• Enthusiasm, accountability, and a strong work ethic are essential.

Why Join Us?

• Competitive salary of $60,000–$70,000 plus bonus potential.
  

• Direct-hire employment opportunity.
  

• Comprehensive benefits package.
  

• Consistent Monday–Friday schedule
  

•  year-end leave from December 24 through January 2.
  

• Opportunity to contribute to quality, compliance, and continuous improvement in a regulated manufacturing environment.

Interested in taking the next step in your quality assurance career? Apply today to learn more about this opportunity in Lancaster, SC.
 

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