Laboratory Document Control Specialist

Job Summary:

The Enterprise Quality Support Specialist will play a key role in the Quality Department, providing support for Enterprise-level projects related to document control functions. The Specialist will focus on the maintenance and administration of document control systems to ensure alignment with internal procedures and applicable regulatory requirements. This includes developing and implementing documentation procedures, managing document control processes, and facilitating the distribution of controlled documents throughout the organization. The role also involves collaborating with various departments to implement specific documentation vaults, conducting training sessions, and coordinating responses during audits and inspections. The Specialist will actively contribute to the establishment and maintenance of an Enterprise-wide Quality Assurance Program.

The Enterprise Quality Support Specialist is expected to divide their time equally between Quality-specific and Enterprise-wide functions. The role will involve planning, implementing, and monitoring the Quality Management System (QMS) while ensuring compliance with quality and productivity standards. Experience with FDA regulations is preferred.

- Administer the organization s document control systems, addressing user queries, and managing personnel onboarding/offboarding in software portals.

- Develop and maintain documentation templates, including SOPs, Work Instructions, Forms, Technical Files, and Specifications.

- Manage document control processes, including assigning and tracking document control numbers, overseeing the review and approval process, and distributing approved documents.

- Collaborate with departments to implement specific documentation vaults and provide necessary training to staff.

- Coordinate responses for controlled documents during internal and external audits.

- Oversee the distribution, maintenance, and destruction of physical copies of controlled documents across affiliated facilities.

- Assist with document retention and destruction as per legal requirements.

- Assist in creating and implementing Quality Assurance programs for non-laboratory departments.

- Facilitate communication between QA Management and non-laboratory departments regarding Quality Assurance programs.

- Conduct audits, track metrics, and present findings related to Enterprise-wide Quality Assurance programs.

- Maintain procedural manuals for all laboratory areas.

- Participate in audits and accreditation inspections as required.

- Manage controlled and hard copies of documents for the production floor.

- Generate, review, and distribute documents, ensuring accuracy.

- Assist in data collection for Quality Reports and establish effective systems to monitor accuracy assessments and data quality.

- Provide orientation/training to new and existing staff.

- Communicate departmental changes to senior leadership and C-suite.

- Actively participate in Safety and QA/PI Committee meetings and implement necessary changes.

- Review and maintain maintenance records.

- Contribute to overseeing clinical laboratory departments to ensure optimal performance and high morale.

- Associate degree in a healthcare-related field required; Bachelor s degree strongly preferred.

- Strong interpersonal and teamwork skills with the ability to build productive relationships.

- Proficiency in document control principles, regulatory requirements (e.g., Good Documentation Practices, CLIA/CAP standards, ISO standards, and FDA regulations).

- Proficient in Microsoft Office programs such as Outlook, Excel, Word, PowerPoint, and Teams.

- Excellent oral and written communication skills.

- Critical thinker with meticulous attention to detail.

- Strong organizational skills with the ability to manage multiple projects simultaneously.

- Previous experience in document control within clinical laboratory, pharmaceutical, medical device, or related industry.

- Experience administering document management systems (e.g., Media Lab, Master Control).

- 2 years of prior clinical laboratory experience preferred.

- Experience in drafting technical documents is a plus.

**Certifications/Licenses:**

- Document management certification (i.e., DMCP) strongly preferred.

- Associate degree in a healthcare-related field required; Bachelor s degree strongly preferred.

- Strong interpersonal and teamwork skills with the ability to build productive relationships.

- Proficiency in document control principles, regulatory requirements (e.g., Good Documentation Practices, CLIA/CAP standards, ISO standards, and FDA regulations).

- Proficient in Microsoft Office programs such as Outlook, Excel, Word, PowerPoint, and Teams.

- Excellent oral and written communication skills.

- Critical thinker with meticulous attention to detail.

- Strong organizational skills with the ability to manage multiple projects simultaneously.

- Previous experience in document control within clinical laboratory, pharmaceutical, medical device, or related industry.

- Experience administering document management systems (e.g., Media Lab, Master Control).

- 2 years of prior clinical laboratory experience preferred.

- Experience in drafting technical documents is a plus.

- Document management certification (i.e., DMCP) strongly preferred.