Packaging Quality Specialist

Adare Pharma Solutions•Philadelphia, PA

10d•Onsite

About The Position

The Packaging Quality Specialist is a critical member of the Operations team, responsible for all documentation and procedural activities associated with batch records, 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.

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).
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

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