Quality Assurance Document Control Senior Associate

Your Role:

The Quality Assurance Document Control Senior Associate plays a key role in maintaining and safeguarding the company's historical and regulatory documentation. This position is responsible for organizing, preserving, and managing both physical and digital records that support GMP activities. This position issues controlled GMP documentation to the manufacturing floor and analytical laboratory. By ensuring proper documentation storage, retrieval, and disposal protocols, the Quality Assurance Document Control Senior Associate contributes significantly to regulatory compliance and operational continuity.

• Manage and maintain the records room, which includes scientific data, regulatory history, development reports, environmental monitoring records, and GMP batch-related records and documentation. Ensure accurate organization and accessibility of all records.
• Act as the central resource records requests. Ensure efficient access to historical data for internal departments.
• Draft Certificates of Analysis and other batch release documents
• Issue controlled GMP documents (batch records, logbooks, forms, report numbers).
• Educate QA Operations staff on archiving best practices, document retention, and proper records handling. Encourage site-wide awareness of record retention policies and procedures.
• Continuously evaluate and improve documentation systems and tools. Keep up with advancements in information management, records compliance, and archiving technologies.
• Monitor compliance with regulatory guidelines from health authorities like the FDA, EMA, ANVISA, Health Canada, and other global agencies. Manage retention schedules and documentation lifecycle protocols in line with legal and business needs.
• Develop and oversee a digital records system aligned with company IT standards. Facilitate the transition from paper to electronic formats when needed and index electronic records for ease of retrieval.

Who You Are

Minimum Qualifications:

• High school diploma or GED 
• 1+ years in an FDA-regulated setting

Preferred Qualifications:

• Bachelor’s degree in any discipline or Associate’s degree plus 3 years of GMP experience or Records Management certification.
• 3+ years in an FDA-regulated setting performing document or records. management; or applicable experience (cGMP pharmaceutical quality assurance experience is preferred). 
• Familiarity with GMP requirements.
• Experience using electronic document or record management systems.
• Knowledge of pharmaceutical documentation, regulatory documentation, and document lifecycle management.
• Experience with cloud-based content and records management systems.
• Ability to engage with cross-functional teams and adapt to evolving compliance needs.
• Proficient in Microsoft Word and Excel.
• Strong communication skills and the ability to work independently while managing multiple tasks.
• Detail-oriented with strong organizational abilities.

RSREMD