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.
