Specialist, Manufacturing Quality

Specialist, Manufacturing Quality Vandalia, OH Job Details Full-time 1 day ago Benefits Relocation assistance Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance 401(k) matching Qualifications Quality control corrective actions Microsoft Excel Procedural guides Technical documentation ISO standards Regulatory compliance Safety standards in production Compliance audits & assessments Filing Data reporting Corrective and preventive actions (CAPA) Mid-level 3 years High school diploma or GED Manufacturing standard operating procedures Continuous improvement Decision making Organizational skills Technical writing Productivity software Quality audits Quality assurance within manufacturing Manufacturing Root cause analysis Associate's degree Manufacturing company experience Communication skills Project stakeholder communication Progress tracking (project management tasks) FDA regulations Stakeholder management Full Job Description 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 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.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

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.

REQUIRED SKILLS AND QUALIFICATIONS

Associates degree with 3 years of experience in manufacturing or HS Diploma with 5 years of experience in manufacturing. Technical writing and/or procedure development, preferred. Knowledge of Oral Solid Dose / Tablet manufacturing techniques a plus FDA or other regulated environment a plus 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

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