Senior Specialist, Manufacturing Quality

Vandalia, 845 Center Drive, Vandalia, Ohio, United States of America

Posted Friday, May 16, 2025 at 10:00 AM

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success.

With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare
!

What can Adare offer you?

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

We are seeking to hire a Sr. Specialist, Investigations Technical Writing to join our
Operations team…

If any of the below describes you, we would love to meet you!

JOB SUMMARY

The Senior Specialist, Investigations Technical Writing is a critical member of the Operations team, responsible for all documentation and procedural activities associated with non-conformance investigation reports and actions that come out of the reports. This includes investigation, analysis, and writing of non-conformances and the associated reports. This includes investigation, analysis, and writing of non-conformances and the associated reports. In-depth knowledge of pharmaceutical manufacturing techniques and performing root cause analysis are critical for this position.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• Perform investigation activities and writing deviation investigation reports supporting non-conforming (process and procedural deviation) events
• Deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc.
• Perform thorough investigations of Manufacturing non-conforming events and customer complaints that could include review of cGMP documents and historical review of the quality management system
• Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause
• Provide documentation services to the Manufacturing department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.
• Support all Quality Systems for the Manufacturing Department, including CAPA, Change Control, NCIR tracking/trending.
• Review, update and approve Standard Operating Procedures (SOPs) and other official documents.
• Support Quality Systems for the Manufacturing Department, including CAPA, Change Control, NCIR tracking/trending.
• Identify appropriate Corrective Action, Preventative Action (CAPA) as needed. Responsible for completion of CAPA and follow-up on effectiveness.
• Support all Continuous Improvement efforts within the department
• Develop and maintain a system for monitoring and reporting department metrics on a continual basis.
• Develop, plan, track and analyze assigned projects. Works with project sponsor(s) to define project success criteria, timelines, milestones and deliverables. Identifies project dependencies and critical paths.
• Effectively communicate and manage project expectations and success criteria to project sponsors, team members, vendors and other stakeholders in a clear and concise manner throughout the project lifecycle.
• Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines.
• Support Operations in reducing compliance risk by aiding in performing internal audits and developing action items to correct risks
• Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code

REQUIRED SKILLS AND QUALIFICATIONS

• Bachelor’s Degree in science or engineering field
• 4+ years' performing investigations in a GMP environment
• Knowledge of Oral Solid Dose / Tablet manufacturing techniques
• Experience technical writing and/or procedure development, preferably in FDA regulated environment.
• Proficient with Microsoft Office (Excel, Word, PowerPoint).
• Capable of organizing data from multiple sources, extracting key information and writing reports and summaries
• Demonstrated ability to write logically and consistently
• Strong decision making and problem solving skills
• Excellent interpersonal written and oral communication skills

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age,…