Document Control Specialist

Position Summary:  Plans and conducts activities associated with the quality assurance and compliance of Cosmetic, Drug and Medical Device processes, materials, systems and products by performing duties related to initiation, approval and closure of Change Management and Quality Records. This Document Control Specialist will ensure his/her activities maintain compliance with FDA, international/global regulations, and the ISO 13485:2016 standard as related to document control, change management, training and batch record review/disposition activities.

Essential Duties and Responsibilities:

• Ensure that QA functions are compliant with all required GMP regulations.
• Assist in the conduct of internal and external audits as necessary.
• Scan and file all training records, change management records and batch records as required.
• Assist the Document Control and Quality management with the biannual review of SOPs, uniPoint reconciliation/verification, vendor change control and customer changes as required.
• Assist Document Control management with the monitoring and maintaining of the site document control system including creation, revision, and approval SOPs as required as well as monitoring of metrics, performance indicators related to change management.
• Maintain and improve the level of GMP compliance and stay abreast of industry and regulatory compliance trends and requirements.
• Ensure that all operations are performed in accordance with SOP’s, FDA and GMP guidelines.

• Receive and analyze appropriate test results for the release of final product materials.
• Review and audit completed batch records, change controls, change requests, DCN records, SOP binders to verify compliance to governing procedures and regulations.
• Scan completed batch records into Laserfiche. Upload records into uniPoint. Complete tasks in uniPoint.
• Follow up with personnel on CAPA and NCR reports as well as any change related to deliverable, training records, uniPoint or Laserfiche tasks.

Essential Skills and Qualifications:

• Bachelor's degree in Science, Engineering, or a related field preferred.
• Minimum of 3 years of experience in a regulated manufacturing environment (e.g., pharmaceutical, medical device).
• Experience in Document Control, Batch Record Review, or a relevant Quality/Compliance function is essential.
• Excellent written and verbal communication skills.
• Ability to read, analyze, and interpret technical documents (e.g., SOPs, protocols, reports, regulations).
• An ability to effectively communicate with internal and external stakeholders (e.g., clients, auditors).
• Ability to work with mathematical concepts such as probability, frequency, and basic statistical sampling.
• Strong analytical and data analysis skills.
• Strong analytical and problem-solving skills with a focus on risk assessment and compliance.
• Ability to apply critical thinking and sound judgment in decision-making.
• Ability to identify and resolve document-related issues effectively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with Adobe Acrobat and QMS software.
• Ability to efficiently generate certificates, quality records, and electronic reports.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Must be able to lift up to 25 lbs. Bending, reaching and climbing stairs and short ladders or step stools.

The above job description is not intended to be an all-inclusive list of duties and standards of the position.  Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Candidates selected for employment will be required to complete a pre-employment screening, including a drug test, employment verification, and education verification.