The
Document Control Specialist assists the Quality team by maintaining and continuously working to improve the integrity of quality processes, data management, documentation control, training, and the Quality Management System (QMS). This role reports to the Quality Manager.
Responsibilities:
- Support QA Technicians as needed with inspections, press/machine checks, comparator checks, reworks of defective products, etc.
- Organize and maintain accurate data and documentation in the Quality Management System (QMS).
- Support internal and external audits and investigations.
- Collaborate with relevant departments to gather necessary information for documentation and ensure compliance with customer, ISO, and internal safety and quality requirements.
- Ensure policies, procedures, and controlled documents remain current, accurate, and compliant with ISO standards and corporate requirements within the QMS.
- Develop and administer document control and quality compliance training; maintaining audit-ready completion records within QMS.
- Synthesize QMS and quality performance metrics (audit results, nonconformances, customer complaints, training compliance, document revision cycle time, etc.), applying advanced data analysis (Excel functions, formulas, pivot tables) to identify trends and deliver clear, actionable quality reports.
- Facilitate cross-functional Continuous Process Improvement (CPI) initiatives by analyzing nonconformances, audit results, safety incidents, customer feedback, and process performance data to drive sustainable Corrective and Preventive Actions (CAPAs).
- Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs).
- Other duties as assigned.
Qualifications:
- High School diploma or GED with a minimum of two years of experience in industrial quality control or related field.
- Advanced proficiency in Microsoft (Word, PowerPoint, Excel) is required.
- Strong attention to detail and effective written and verbal communication skills.
- Experience with ISO 9001 Standards and Quality Management Systems (QMS)
- Demonstrate understanding of calibration and traceability requirements
- Internal auditor certification, preferred.
- Strong analytical, organizational, and problem-solving skills
- This position will perform work in an industrial environment. Must be able to lift up to 50 lbs (with or without mechanical assistance), regularly sit, stand, bend, reach, and move about the facility. Regularly exposed to noise, dust, odors, fumes, and oils.