Endo · 1 day ago
Sr. Quality Analyst
Triangle Area
Full-time
Onsite
Mid, Senior Level
3+ years expEndo is committed to improving lives through quality healthcare, with a global team of over 4,000 members. The Sr. Quality Analyst will be responsible for customer inquiries, gap assessments, and audit coordination, ensuring compliance with quality standards and supporting product release operations.
Pharmaceuticals
Responsibilities
Utilize inventory management systems (BPCS) and other associated quality systems to ensure proper release of product for the Raleigh manufacturing site
Primary point of contact for the Raleigh site for customer inquiries and required documentation for GMP customer requests
Schedule customer audits and coordinate all associated activities, including but not limited to tracking responses and action items to completion
Maintenance of the Site Inspection Readiness Program
Act as a primary back-up for batch record reviews. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts
Reviews and approves Certificate of Analysis (CoA) documents
Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both, QA and QC as well as filing
Provides support to investigations, both exceptions and OOSs, to support product disposition
Programs label changes and add new codes to the labeling computer
Makes, proofs, and records all finished lot labels to meet the production schedule and as requested by production personnel
Issues final product labels and batch records to production
Corresponds with customers via routine customer inquiries
Provides support to intermediate labeling and tank inspections as needed
Participates in a certified 5S Workplace System to ensure good housekeeping and organization
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy
Effectively trains and works with others in a positive manner
Qualification
Required
High School Diploma, GED, or equivalent
Associates of Science (AS) degree in a related field
Requires thorough knowledge of site quality procedures and GMP to appropriately audit and perform records functions associated with site compliance to FDA regulations
Attention to detail, organization, time management, and effective communication are needed for this position
Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks
Sound judgment must be used in evaluating plant compliance with GMP standards and initiative is required to facilitate changes needed
A good working relationship with various levels of personnel and management
Good coaching skills are required when providing assistance and guidance to site internal auditors
Preferred
Bachelors of Science (BS) or equivalent life science degree preferred
Minimum of three years of experience preferred in a Quality auditing and batch record review role
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
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