Specialist, Manufacturing Quality

Adare Pharma Solutions Recruiting Team•Vandalia, OH

About The Position

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! We are seeking to hire a Specialist, Manufacturing Quality to join our Operations team… JOB SUMMARY The Specialist, Manufacturing Quality is a critical member of the Operations team, responsible for supporting documentation and procedural activities associated with non-conformance investigation reports and actions that come out of the reports. This includes participating in investigation, analysis, and writing of minor non-conformances and the associated reports.

Requirements

Associates degree with 3 years of experience in manufacturing or HS Diploma with 5 years of experience in manufacturing.
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
Assertive Influencing & Collaboration/Teaming Skills
Strong decision making and problem solving skills
Excellent interpersonal written and oral communication skills
Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
Exceptional attention to detail and excellent organizational skills

Nice To Haves

Technical writing and/or procedure development, preferred.
Knowledge of Oral Solid Dose / Tablet manufacturing techniques a plus
FDA or other regulated environment a plus

Responsibilities

Provide documentation services, mainly minor OOS Investigations, to the Manufacturing department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.
Work with Senior Specialist on Root Cause Analysis and proper investigations for minor OOS and Deviation cases.
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 all Continuous Improvement efforts within the department.
Support monitoring and reporting department metrics on a continual basis.
Provide assistance to execute, track and analyze assigned projects. Help identify any 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 Manufacturing Manager 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.
Works effectively under deadlines.
Respects policies, procedures and regulations in force in the company.
Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.