We are seeking to hire a Senior Specialist, Manufacturing Quality to join our Operations team…

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

JOB SUMMARY

The Senior Specialist, Manufacturing Quality 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. The job function is also to identify opportunities for improvement, and implementing both process improvements to further the efforts in the Manufacturing group. It also includes project execution within the department, in addition to other daily functions needed.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• 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.
• Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines.
• 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.
• Aid in support and help 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.
• 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
• Perform all these functions, and others, as required by the Manufacturing Manager in a professional and timely manner.
• 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.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• 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
• Minimum one year 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
• 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

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, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES