Senior Quality Assurance Compliance Specialist

Piramal • Bethlehem, PA

156d

About The Position

The position provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements. The role involves proper control, review, and management of site documentation to ensure GMP and regulatory compliance.

Requirements

• 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.

Nice To Haves

• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.
• Excellent verbal and written communication skills.
• Energetic, enthusiastic, and motivated disposition.
• Attention to detail with strong organizational skills.
• Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner.
• Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports.
• The ability to drive projects in relation to implementation of new workflows and updates to new systems.

Responsibilities

• Responsible for the review, approval, and disposition of finished product for the site and final CoA signature.
• Facilitates 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 and 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 trainings.
• 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.
• Maintains the vendor complaint process.
• Maintains, monitors and provides trend analysis of DIs, LIs, CAPAs, customer complaints and change controls.
• Performs special projects and/or assignments as indicated by Quality Management.
• Oversees and reviews Obsolete material destruction.
• Performs Quality inspections on packaging line as needed.
• Maintains supplier approval program.
• Supports/Maintains site Document Control System.
• Reviews, approves and closes out Document Change Requests.
• Tracks changes using DCC spreadsheet and supports actions through closure.
• Maintains original documentation archive and archival of documents offsite.
• Prints new and revised documents, issues forms, logbooks.
• Reviews documentation submitted for routing in eDMS for proper formatting and accuracy.
• Loads documents into an electronic Documentation Management System (eDMS).
• Routes documents for approval in the eDMS.
• Recalls documentation for audits in a timely manner.
• Performs external audits and assists in writing reports for audits.
• Responsible for maintenance and revision procedures related to document control.

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees