Quality Systems Specialist

Job Responsibilities

• Provide support in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
• Ensures investigations are logged, triaged, investigated, and resolved according to established deadlines, company and regulatory requirements.
• Coincides with cross-functional teams for testing of reserve or retain samples for investigation purposes, where applicable.
• Coincides the reviews of relevant records, (e.g. batch records, quality control data, quality investigations, etc.).
• Conducts root cause analysis in order to facilitate and initiate corrective and preventative actions wherever needed.
• Tracks quality system metrics and creates detailed trend analysis reports.
• Performs analysis of data, trending and provides metrics for Quality Systems, as required.
• Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.
• Coordinates evaluation of implementation for Global Policies and Procedures
• Evaluates and assists in the implementation of new changes for the site.
• Supports implementation of projects that improve site Quality and/or efficiency.
• Assess changes in terms of their impact to CGMP and using Risk Management tools.
• Prepares and compiles the required data to support the APR submission for the products manufactured on site.
• Provide support to collect and prepare QMR board presentation and associated documentation.
• Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.
• Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, Deviations.
• Coordinate and collect information from departments for performing QMR and annual product review.
• Establish, revise, review and continuously improve procedures for all Quality Systems.
• Establish Key Performance Indicators (KPIs) for functional area and ensure systems are operating within target.

Requirements

• Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills

• Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.
• Proactive, results-oriented with a strong attention to detail and strong time management skills.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment.
• Ability to analyze details and perform structured decision-making on a daily basis.
• Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
• Intermediate Excel and/or Minitab skills are required including, but not limited to: spreadsheet manipulation, charting, and analysis tools.
• Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
• Self-starter with the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
• Any quality or lean/Six Sigma certifications are a plus.