SOP & Documentation Specialist

Location: Kennett Square, PA
Department: Quality Assurance & Compliance
Reports To: QA Leadership

Role Overview

The SOP & Documentation Specialist is responsible for building, maintaining, and enforcing clear, compliant, and executable documentation across Boothwyn Pharmacy.

This role ensures that SOPs are not only regulatory-compliant, but also practical, understood, and consistently followed across operations.

You will play a key role in driving standardization, reducing errors, and always ensuring inspection readiness.

What You’ll Do

Own SOP Development & Control

  • Create, revise, and maintain SOPs, work instructions, and controlled documents

  • Ensure documentation is clear, accurate, and aligned with current practices

  • Manage document lifecycle including version control, distribution, and updates

Drive Compliance & Audit Readiness

  • Support inspection readiness across FDA, USP, DEA, OSHA, and state requirements

  • Conduct routine audits and ensure findings are documented and resolved

  • Maintain documentation to support audits, inspections, and regulatory reviews

Lead Deviations & CAPA Documentation

  • Investigate deviations and non-conformances

  • Document and track CAPAs through closure

  • Ensure all corrective actions are reflected in SOP updates and training

Support Training & SOP Adoption

  • Facilitate training in new and revised SOPs

  • Ensure staff understanding and documented competency

  • Partner with operations to ensure SOPs are followed consistently

Drive Continuous Improvement

  • Identify gaps in processes, documentation, and compliance

  • Recommend and implement improvements across production workflows

  • Monitor regulatory updates and ensure documentation remains current

Performance Expectations

  • Review and update 2–3 SOPs per week

  • Draft 1–2 new SOPs weekly as needed

  • Deliver regular SOP training sessions to staff

  • Ensure timely closure of deviations and CAPAs

  • Always maintain audit-ready documentation

What We’re Looking For

  • Certified Pharmacy Technician (required or strongly preferred)

  • Experience in non-sterile compounding preferred

  • Strong attention to detail and accuracy

  • Ability to follow procedures and maintain compliance

  • Team-oriented with strong communication skills

  • Ability to work in a fast-paced, regulated environment

  • Experience with high-volume compounding environments preferred

Physical Requirements

  • Ability to stand for extended periods

  • Ability to lift and move materials as needed

  • Ability to work in a controlled lab environment with PPE

Why Boothwyn

  • Work in a highly specialized compounding environment

  • Opportunity to build technical expertise in pharmacy operations

  • Stable, growing organization with strong compliance standards

Equal Opportunity

We are an equal opportunity employer committed to building a diverse and inclusive team.

Apply Now