Document Control Specialist

Akina Pharmacy • Sterling, VA

44d

About The Position

The Document Control Specialist is the owner of Akina Pharmacy’s controlled documentation system. This role is responsible for ensuring SOPs, policies, work instructions, forms, logs, templates, and associated quality records are accurate, current, approval-controlled, and inspection-ready at all times.

The Document Control Specialist manages the full document lifecycle, including document creation support, review and approval routing, version control, periodic review, training linkage, archiving, retention, and rapid retrieval during audits or inspections. This role partners closely with Quality, Regulatory, Operations, and Leadership to ensure documentation supports compliant, scalable pharmacy operations.

Success in this role is rooted in Akina’s values—Excellence Always, Go-Getter’s Unite, Compassion For All, and Called To Serve—and will be evident in your commitment to compliance, training, data integrity, and collaboration.

Requirements

• Associate or Bachelor’s degree preferred (Life Sciences, Quality, Technical Writing, Healthcare Administration, or related field).
• 2–5+ years of document control or quality documentation experience in a regulated environment (pharmacy, pharmaceutical, biotech, or medical device).
• Working knowledge of cGMP, USP <797>, <795>, and <800>.
• Proficient in digital quality management systems, data tracking tools, and SOP documentation platforms.
• Strong understanding of SOP lifecycle management, version control, and Good Documentation Practices.
• Experience with electronic document management systems (Google Drive, Google Doc, eQMS).
• Exceptional attention to detail and organization.

Nice To Haves

• Experience in pharmaceutical compounding operations or regulated environments is preferred.

Responsibilities

• Own the end-to-end lifecycle of all controlled documents (SOPs, policies, work instructions, forms, logs, templates, and related quality records). Ensure documents are properly formatted, version-controlled, approved, issued, and maintained in accordance with Good Documentation Practices (GDP). Ensure only current, approved documents are available at point-of-use and obsolete documents are promptly removed and archived.
• Coordinate document drafting support and route documents for review and approval in accordance with defined approval authorities and Quality oversight. Manage document revisions resulting from process changes, regulatory updates, audits, or continuous improvement initiatives. Ensure all changes are traceable, justified, and documented with clear version history and effective dates.
• Own and track periodic document reviews (annual or risk-based) to ensure documentation remains current, accurate, and aligned with actual practice. Identify documentation gaps, redundancies, or outdated content and escalate for remediation. Maintain dashboards or trackers to ensure review commitments are met on time.
• Coordinate assignment and tracking of training tied to controlled documents, ensuring staff are trained on new or revised procedures by required effective dates. Maintain clear evidence linking documents, revisions, approvals, and training completion. Support audits and inspections by ensuring documentation and training records are organized, complete, and inspection-ready.
• Maintain secure archiving and retention of controlled documents and quality records in accordance with internal policy and regulatory expectations. Ensure rapid retrieval of current and historical documents, including approval and training history, during inspections, audits, or regulatory inquiries. Serve as the primary point of contact for document requests during audits and inspections.

Benefits

• Medical and Supplementary Benefits: Akina Pharmacy offers two medical plan options with employer premium contributions up to 85%, dental and vision coverage, accident and hospital indemnity, and company paid long term and short-term disability options, available after 30 days of employment.
• Paid Time Off
• Paid Holidays: Enjoy six scheduled paid holidays to celebrate and spend quality time with loved ones.
• 401K Match: Invest in your future with our 401K plan, featuring a Safe Harbor match up to 4%.
• Rewards & Recognition
• No Cost Medication: Employees are eligible to receive prescribed compounded medications at no cost, after 30 days of employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree