Specialist, Quality Systems Investigations

Specialist, Quality Systems Investigations

The Quality Systems Investigations Specialist leads the site investigation, CAPA, change control, risk management and management review processes. The Quality Systems Specialist will actively engage the cross-functional teams, site and corporate management to lead Quality Events, Deviations, Corrective and Preventative Actions, and Investigations to closure. The individual will facilitate the Investigation and CAPA Review Boards and support the site Change Controls, QMR, and Risk Management processes, among others. This individual assists in monitoring quality system health and business process performance via metrics and trending, proactively identifying, providing guidance, and implementing process and system improvements to resolve complex issues promptly ensuring a smooth and efficient work process.

Responsibilities

• Ensures investigations are logged, triaged, investigated, and resolved according to established deadlines and company and regulatory requirements.
• Coordinates with cross-functional teams for testing of reserved or retained samples for investigation purposes, where applicable.
• Coordinates the reviews of relevant records (e.g., batch records, quality control data, quality investigations, etc.)
• Conducts root cause analysis to facilitate and initiate corrective and preventative actions wherever needed.
• Performs analysis of data, trending, and provides metrics for Quality Systems, as required.
• Ensure Quality Systems comply with CGMPs and internal/external regulations and procedures.
• Coordinates evaluation of implementation for Global Policies and Procedures
• Supports implementation of projects that improve site Quality and efficiency.
• Assess changes in terms of their impact on CGMP and use 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.
• Complete and maintain certified investigator training requirements to ensure SIT representation for identified area(s).
• Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPAs.
• Participate in continuous improvement initiatives for investigations and associated investigation certification process.
• Work with CIT team as needed for Major and Critical Investigations to align with corporate guidelines.
• Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, and Deviations.
• Trains and guides individuals on how to process Quality Events, Deviations, and CAPAs in an effective and efficient way.
• Coordinate and collect information from departments for performing QMR and annual product review
• Holds cross-functional meetings to discuss root cause analysis of investigations and quality events.
• Establish, revise, review, and continuously improve procedures for all Quality Systems.
• Establish key performance indicators (KPIs) for functional areas and ensure that systems operate within the target.
• Track and trend events/deviations
• Develop/author quality SOPs and related documents as needed
• Perform routine audits of processes and gap analysis as needed
• Perform quality review of documentation and processes
• Provide trend reports of quality events

Qualifications

• Bachelor of Science (BS) / Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent
• Minimum 5 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry or a combination of education and experience.
• Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) related to the pharmaceutical industry.
• Must be proactive and results-oriented with a strong attention to detail and 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 daily.
• Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English.
• Strong interpersonal skills with the ability to interact professionally with all personnel levels.
• Intermediate Excel and Minitab skills are required, including, but not limited to, spreadsheet manipulation, charting, and analysis tools.
• The ability to work independently or within a team structure on multiple projects and be flexible enough 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.
• Ability to convince individuals of the minimum requirements for investigations.