WHO WE ARE

Prompt Praxis Laboratories (PPL), headquartered in Vernon Hills, Illinois, is a pioneering small business dedicated to serving the pharmacy compounding industry. Since PPL’s 2011 inception, the women-owned business has grown to over 40 employees and is a fully integrated analytical and microbiological testing laboratory dedicated to quality, speed, and scientific rigor. The company specializes in providing analytical and microbiological rapid testing and support services for pharmaceutical products and compounded sterile or nonsterile preparations. Serving pharmaceutical companies, compounding pharmacies, medical device firms, veterinary products and the wellness industry, PPL leverages automation, advanced information technology and industry leading analytical instrumentation to minimize human error and accelerate drug development timelines for its clients.

CORE QUALIFICATIONS

• BA/BS degree in Science/Chemistry or Biology
• 3 - 5 years of cGMP Quality experience or equivalent with specific experience in technical writing, deviation/excursion reporting, or quality investigations preferred
• Proficient with Microsoft Office: Word, Excel, PowerPoint, and Outlook
• Experience with Quality Management Systems (e.g., Qualio) is a plus
• Demonstrated ability to author clear, concise, and compliant technical reports for regulatory and scientific audiences. Good oral communication skills.
• Ability to comprehend and follow procedures in a cGMP environment
• Ability to exercise a high degree of initiative and judgment to solve problems of medium difficulty
• Good organizational skills and strong attention to detail
• Thorough knowledge of cGMPs, FDA and ICH guidelines. Familiarity with pharmaceutical excursions and their regulatory impact strongly preferred
• Ability to effectively function in a fast-paced work environment
  Job Type: Full-time
  Pay: From $67,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Work Location: In perso

ABOUT THE ROLE

Emphasis will be on drafting, reviewing, and finalizing excursion reports, primarily laboratory OOS’s, and related technical documentation in compliance with cGMP and regulatory standards. Routinely communicate with various individuals or groups on data review, corrections, issues, and solutions. Ensure documentation of experiments is in accordance with company policies and procedures. Collaborate with Quality Assurance staff to develop procedures that support quality activities.

PRIMARY RESPONSIBILITIES

• Maintain knowledge of regulations and legal requirements as well as policies and procedures as relevant to areas of responsibility.
• Draft, review, and finalize excursion reports (e.g., temperature, humidity, equipment, environmental monitoring, utility failures) in alignment with regulatory requirements.
• Translate complex technical findings into clear, structured, and compliant reports for regulatory bodies and clients.
• Ensure excursion documentation is accurate, timely, and audit-ready to support product release, client requirements, and regulatory submissions.
• Support audits and inspections by providing high-quality excursion documentation and investigation summaries.
• Contribute to process improvements in deviation/excursion documentation and reporting workflows.
• Collaborate with laboratory staff, operations, and QA to gather data, investigate root causes, and document corrective and preventive actions (CAPAs).
• Utilizes verbal and written communication strategies to effectively create and relay messages on quality assurance processes, methods and tools.
• Performs other duties as requested.