Packaging Quality Specialist

Responsibilities

• Provide documentation services to the Packaging department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.
• Support all Quality Systems for the Packaging Department, including CAPA, Change Control, NCIR tracking/trending.
• Review, update and approve Standard Operating Procedures (SOPs) and other official documents.
• Identify appropriate Corrective Action, Preventative Action (CAPA) as needed. Responsible for completion of CAPA and follow-up on effectiveness.
• Aid in support and help maintain a system for pre-campaign activities for all packaging 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.
• Perform all these functions, and others, as required by the Packaging Manager in a professional and timely manner.

Requirements

• Bachelor’s degree in writing, math, science or engineering field
• 2+ years’ experience technical writing and/or procedure development, preferably in FDA regulated environment
• Proficient with Microsoft Office (Excel, Word, PowerPoint)
• 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
• Exceptional attention to detail and excellent organizational skills

Qualifications

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.