Quality Assurance Specialist

4 weeks ago

Monroe, North Carolina, United States Glenmark Pharmaceuticals Inc., USA Full time
Job Title: Quality Assurance Specialist

Job Summary:

The Quality Assurance Specialist will be responsible for managing the elements of the Quality Systems, including Change Controls, Quality Events, Deviations, Corrective and Preventative actions, QMR, and Risk Management. This individual will work closely with cross-functional teams at the site and abroad, providing support in resource planning, allocation, and management within approved budgets while building best-in-class quality processes and systems at the site.

Key Responsibilities:

• Ensure investigations are logged, triaged, investigated, and resolved according to established deadlines, company, and regulatory requirements.
• Coordinate with cross-functional teams for testing of reserve or retain samples for investigation purposes, where applicable.
• Coordinate the reviews of relevant records, such as batch records, quality control data, quality investigations, etc.
• Conduct root cause analysis to facilitate and initiate corrective and preventative actions wherever needed.
• Track quality system metrics and create detailed trend analysis reports.
• Perform analysis of data, trending, and provide metrics for Quality Systems, as required.
• Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.
• Coordinate evaluation of implementation for Global Policies and Procedures.
• Evaluate and assist in the implementation of new changes for the site.
• Support implementation of projects that improve site Quality and/or efficiency.
• Assess changes in terms of their impact to CGMP and using Risk Management tools.
• Prepare and compile 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 Indicating (KPIs) for functional area and ensure systems are operating within target.

Requirements:

• Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent.
• Minimum 3 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.) 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.

About Us:

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast-growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

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