Document Control Associate

Essential medicines only reach patients when every record that governs how they are made is accurate, current, and easy to retrieve. This role keeps the quality system trustworthy so manufacturing, quality, and regulatory teams can move with confidence. You will own the document lifecycle that protects product integrity and patient access.

Performance Objectives

• Release controlled documents on time so production and quality can execute without waiting on outdated procedures.
• Maintain a complete, audit-ready repository where the effective version is always the one people use.
• Process change requests so revisions are reviewed, approved, and implemented before obsolete content creates risk.
• Close document-related deviations and audit findings with clear actions and evidence of effectiveness.
• Train and route stakeholders so new and revised procedures are acknowledged before they become effective.
• Report document metrics that show cycle time, overdue reviews, and training completion to quality leadership.
• Support inspections by retrieving requested records quickly and explaining how control is maintained.

Environment & Resources

You will sit with Quality, partner daily with Manufacturing, Regulatory, and Validation, and report to Document Control or Quality leadership. You will work in a validated electronic document management system, with defined workflows, templates, and a controlled archive. Scope covers site procedures, forms, specifications, and related quality records for generic pharmaceutical manufacturing.

Essential Qualifications

• Experience controlling GMP documents in pharmaceutical or similarly regulated manufacturing.
• Working knowledge of change control, periodic review, and good documentation practices.
• Proven use of an electronic quality or document management system to issue, revise, and retire records.
• Ability to manage competing deadlines without losing version control or approval integrity.
• Clear writing and follow-through when coordinating reviewers who do not report to you.
• Associate degree or equivalent experience in a quality, life-science, or operations setting.

Role Selling Points

• Your work directly supports a reliable supply of essential generic medicines.
• A nonprofit mission focused on access and affordability, not volume for its own sake.
• A growing quality organization where document control is a core capability, not an afterthought.
• Visible impact: cleaner audits, faster changes, and procedures people can actually follow.

Call to Action

If you want your standards to protect patients, apply with a short note on a document system you improved and the result you delivered.