Adare Pharma Solutions · 1 day ago
Specialist, Packaging Quality
Philadelphia, PA
Full-time
Onsite
Entry Level
1+ years expAdare Pharma Solutions is a global drug development and manufacturing organization committed to improving patient lives. They are seeking a Specialist in Packaging Quality to manage documentation, procedural activities, and process improvements within the Packaging department, while ensuring compliance with FDA and cGMP standards.
CommercialManufacturingPackaging ServicesPharmaceuticalProduct Design
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
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
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 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
Support Packaging 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 Packaging 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
Qualification
Required
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
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
Company
Adare Pharma Solutions
Adare Pharma Solutions is a technology platform that offers research, development, manufacturing, and delivery of pharmaceutical products.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
T
Tom Sellig
Chief Executive Officer
Recent News
The Philadelphia Inquirer
2025-12-09
Morningstar.com
2025-10-21
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