Document Control Specialist

Document Control Specialist

Company Overview

At Akina Pharmacy, the shared purpose that drives us is to enrich the lives of the people in our care through compounded medications. As a people-first organization, we embrace the Entrepreneurial Operating System (EOS) to ensure our success by prioritizing the recruitment and development of exceptional talent.

Joining Akina means stepping into an environment where clear communication, pragmatic decision-making, and accountability are at the forefront. We are committed to empowering our team members and fostering a culture of growth and support. If you are driven by a passion for making a meaningful impact and seek a vibrant, compassionate workplace, we invite you to discover the opportunities awaiting you at Akina Pharmacy. Together, let's build a healthier, happier community.

Position Summary

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.

You will love it here if you are motivated by Akina's Core Identity Values:

• Excellence Always
• Go-Getter's Unite
• Compassion For All
• Called To Serve

You'll have success here if you value clear processes and get, want, and have capacity to do the following things:

• Controlled Document Lifecycle Ownership

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.

• Review, Approval, and Change Control Coordination

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.

• Periodic Review and Documentation Health

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.

• Training Linkage and Inspection Readiness

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.

• Archiving, Retention, and Rapid Retrieval

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.

We train our team to help them succeed, and everyone on our team helps with our success. In this role, you'll be accountable for hitting the following numbers:

• Document Review Compliance: ≥95-100% of scheduled document reviews completed on time.
• Version Integrity: 100% of controlled documents current and approved at point-of-use.
• Training Completion: 100% required training completed within defined timelines.
• Inspection Readiness: Critical documents retrievable within minutes during inspections.

Our company runs on EOS purely. That means as a member of this team, you will have a leader who:

• Gives clear directions and expectations
• Makes sure you have the necessary tools
• Delegates appropriately
• Has effective meetings
• Meets one-on-one with you quarterly or more, if needed
• Rewards and recognizes your performance

Experience and Qualifications

• Education: Associate or Bachelor's degree preferred (Life Sciences, Quality, Technical Writing, Healthcare Administration, or related field).
• Expertise: 2-5+ years of document control or quality documentation experience in a regulated environment (pharmacy, pharmaceutical, biotech, or medical device).
• Regulatory Familiarity: Working knowledge of cGMP, USP <797> , <795> , and <800> . Experience in pharmaceutical compounding operations or regulated environments is preferred.
• Technology Skills: Proficient in digital quality management systems, data tracking tools, and SOP documentation platforms. Comfortable navigating and adapting to evolving technology systems.
• Soft Skills: 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.

Benefits & Perks

• 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: Take advantage of generous paid time off to recharge, focus on personal priorities, and maintain a healthy work-life balance.
• 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: Be celebrated for your hard work and achievements through our dedicated rewards and recognition program.
• No Cost Medication: Employees are eligible to receive prescribed compounded medications at no cost, after 30 days of employment.