Our well estblished pharmaceutical client is looking for a Senior Quality Specialist to join their growing team. Our client is looking for someone to be apart of their crucial success where your contributions and expertise will make a significant impact.

Essential Duties and Responsibilities

• Responsible for the review, approval, and disposition of finished product for the site and final CoA signature.
• Client project management as required ensuring “quality on time and in full”.
• Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed.
• Leads or participates in focused deviation cross-functional investigations, improvement projects.
• Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified
• Provides assistance to other QA associates and assist with department training.
• Provides support to QA management during regulatory audits.
• Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs.
• Performs internal audits and assist in writing reports for audits.
• Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining databases.
• Maintain the vendor complaint process.
• Perform Quality inspections on packaging line as needed.
• Support/Maintain site Document Control System.
• Review, approve and close out Document change Requests.

Education / Experience

• Bachelor’s degree in relevant scientific quality assurance / technical field.
• 5 years of experience.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
• Expert level user for Quality computer systems.
• Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
• Thorough understanding of computer system validation and GAMP requirements.