Quality Compliance / Documentation Control Specialist

Schedule: Monday - Friday, 8hr shifts | Pay: Hourly | Location: Onsite at Garner, NC facility | Reports To: Quality Manager

 

The Quality Compliance Specialist is responsible for administration of the Quality Management System (QMS), document control, quality records, quality reporting, training administration, calibration program administration, audit support, and quality compliance activities. This role ensures the integrity, effectiveness, and audit readiness of quality systems while providing data-driven insights that support operational excellence. 

 

Responsibilities:  

• Administer and maintain the effectiveness of the Quality Management System (QMS), serving as the functional administrator for our electronic quality system and database (QCBD) and overseeing document control, quality records, workflows, training records, data integrity, and audit readiness. Ensure policies, procedures, and controlled documents remain current, accurate, compliant, and properly maintained. 

• Own quality performance reporting and analysis by compiling and synthesizing data from QCBD, CERM, ePace, audits, customer complaints, nonconformances, training records, and other applicable sources. Develop KPI reports, dashboards, and trend analyses to identify recurring issues, emerging risks, and opportunities for improvement. 

• Support quality and regulatory compliance by maintaining FSC documentation, administering GMP and quality compliance training programs, maintaining training matrices and records, and ensuring associated documentation remains accurate, complete, and audit-ready. 

• Manage quality system documentation and compliance programs, including document revision control, CAPA tracking, audit documentation, investigation records, and other quality system requirements necessary to support ISO, customer, regulatory, and company requirements. 

• Administer equipment calibration, validation, and supplier qualification programs by maintaining records, monitoring requirements, coordinating activities, and ensuring appropriate documentation, traceability, and follow-up actions. 

• Support internal and external audits, inspections, investigations, and management reviews by preparing documentation, compiling records, coordinating requests, and collaborating with cross-functional teams to ensure compliance and audit readiness. 

• Facilitate Continuous Process Improvement (CPI) initiatives through analysis of quality system data, audit results, customer feedback, nonconformances, safety incidents, and process performance data to identify trends and deliver sustainable Corrective and Preventive Actions (CAPAs). 

• Collaborate with Quality, Operations, and other departments to ensure accurate quality documentation, effective quality system processes, and compliance with applicable customer, ISO 9001, GMP, and company requirements. 

• Other duties as assigned.  

 

Qualifications: 

• High School diploma or GED with a minimum of two years of experience in pharma manufacturing quality control or related field, preferably in the printing or packaging industry.    

• Advanced proficiency in Microsoft (Word, PowerPoint, Excel) is required. 

• Strong attention to detail and effective written and verbal communication skills.  

• Excellent organizational and technical writing abilities. 

• Working experience with ISO 9001 Standards and electronic Quality Management Systems (QMS) required. 

• Demonstrate understanding of calibration and traceability requirements.

• Internal auditor certification, preferred. 

• Strong analytical, data synthesis, and problem-solving skills.

• This position will perform work in an office setting and industrial environment. Regularly required to sit, stand, bend, reach, and move about the facility. Regularly exposed to noise, dust, odors, fumes, and oils.  

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