Manufacturing Documentation Coordinator

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 with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact and 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
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

We are seeking to hire a Manufacturing Documentation Coordinatorto join our Manufacturing Team…

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

JOB SUMMARY

The Manufacturing Documentation Coordinator reports to the Production Manager. The Coordinator will assume responsibility for all documentation and procedural activities associated with commercial production including monitoring of existing documents (including, but not limited to: Batch Records, SOPs, OJT’s/OIMs), identifying opportunities for improvement, and implementing both process and/or procedural improvements to further the efforts in the Manufacturing group to continuously improve. It also includes project execution within the department, in addition to other daily functions needed or requested by the Production Manager.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide documentation services to the Manufacturing department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.
• Provide support for Operational Excellence tracking documents for the department, including formatting, printing, and updating as necessary.
• 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.
• Learn and maintain a thorough understanding of Veeva in order to assist in training and Quality Assurance activities
• Responsible for the SOP biennial review process for Manufacturing, including SOP revisions within the established timelines, as needed.
• Perform all aspects of logbook maintenance, including creation, review, retirement, and filing functions.
• Responsible for preparation of the Manufacturing Section for Annual Product Reviews (APRs), including data collection, document preparation, and identification of applicable CAPAs as necessary.
• This position may also be involved with product investigations which support the Manufacturing team as well as supporting the Manufacturing Training Coordinator as needed.
• Support all Continuous Improvement efforts within the department.
• Optimize and maintain a system for Pre-campaign activities for all manufacturing processes.
• 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.
• Manage multiple, concurrent departmental and organizational projects from beginning to end.
• 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.
• Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
• Perform other tasks as required.

Requirements

• High School diploma and 1+ year(s) 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.
• Ability to coordinate, contribute to and work within a cross-functional team.
• Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.

Benefits

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