Documentation Control Specialist, Quality Assurance

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The Document Control Specialist will be responsible for ensuring the efficient management and compliance of documentation processes within the organization. This role involves the creation, maintenance, and distribution of controlled documents, ensuring adherence to company policies, regulatory standards, and quality requirements. The Document Control Specialist will oversee the accuracy, accessibility, and confidentiality of critical documentation and support cross-departmental collaboration to maintain smooth operations. This position is integral in upholding operational efficiency, regulatory compliance, and quality assurance across the organization.

Hybrid Role based out of Lakewood, New Jersey location

• Document Control: Update, manage, and maintain procedure documents and forms, ensuring they meet compliance standards and are aligned with company policies.

• Process Management: Develop and implement document control procedures, ensuring a structured system for document retrieval, distribution, and storage.

• Training & Support: Provide training to employees on proper document management practices and ensure adherence to regulatory requirements.

• Quality Assurance: Verify that all documents are compliant with internal quality standards, regulatory guidelines, and industry best practices.

• Documentation Distribution: Coordinate the distribution and access of controlled documents across departments, ensuring the right personnel have timely access to up-to-date information.

• Data Entry & Accuracy: Maintain accurate records in document control registers and other tracking systems, ensuring timely and accurate updates.

• Filing & Database Management: Develop and maintain a comprehensive filing system, both physical and electronic, for the retention of all controlled documents.

• Confidentiality: Ensure that sensitive documentation is handled with strict confidentiality, in line with organizational policies and legal requirements.

• Audit & Reporting: Prepare and assist in audits, ensuring all documentation is compliant with relevant standards, and generate reports to track document discrepancies and improvements.

• Document Revision: Regularly review and update documents to ensure they reflect current policies, procedures, and regulatory requirements.

• Record Review: Work closely with quality personnel and other departments, as assigned, to ensure that critical records are completed in accordance with Good Documentation Practices and the applicable procedures.

• Collaboration & Support: Work closely with other departments to ensure that all document control activities align with operational needs and compliance expectations.

• Regulatory Compliance: Assist with ensuring that all documents meet applicable regulatory requirements and standards, including preparation for audits and inspections.

• Additional Duties: Execute additional tasks as assigned by Document Control or Quality Assurance Management

The above duties are meant to be representative of the position and not all-inclusive.

MINIMUM JOB REQUIREMENTS:

• High School Education or GED
• 1-2 years of experience in a quality related role within an FDA regulated environment
• Pharmaceutical or medical device background strongly preferred
• Experience working in an eQMS and WMS/ERP system

KNOWLEDGE, SKILLS & ABILITIES:

• Intermediate mathematical skills (add, subtract, multiply, divide, compute rate, ratio, and percent)
• Good oral and written communication skills, with proficiency in English; Spanish speaking is a plus
• Flexibility to adapt to the demands of the position
• Able to interpret ANSI sampling standards
• Working knowledge of current Good Manufacturing Practices and Good Documentation Practices
• Experienced in Microsoft Excel, Word, and other computer applications

PHYSICAL DEMANDS:

• Frequently required to stand or sit
• Regularly required to reach, pull, stoop, bend, kneel and/or crouch
• Occasionally lift and/or move objects up to 35 lbs.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.