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Endo · 19 hours ago

Sr. Quality Analyst

Raleigh, NC (Pharma) - USA033

Full-time

Onsite

Mid, Senior Level

3+ years exp

Endo is a company committed to improving lives through quality healthcare. The Sr. Quality Analyst will serve as the primary contact for customer inquiries and audit coordination, ensuring compliance with GMP regulations and maintaining inspection readiness for the Raleigh manufacturing site.

Pharmaceuticals

Comp. & Benefits

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

Quality auditingBatch record reviewGMP complianceAttention to detailEffective communication

Required

High School Diploma, GED, or equivalent

Associates of Science (AS) degree in a related field

Minimum of three years of experience in a Quality auditing and batch record review role

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

Preferred

Bachelors of Science (BS) or equivalent life science degree preferred

Company

Endo

Glassdoor3.8

Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.

Founded in 1997

Malvern, , US

1001-5000 employees

Funding

Current Stage

Late Stage

Leadership Team

Blaise Coleman

President and Chief Executive Officer

Jennifer Lynn Fernandez

Sr. Executive Coordinator to President and CEO

Recent News

PR Newswire

Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with Three New Concentrations

2025-09-23

PR Newswire

Mallinckrodt Names Dr. Marek J. Honczarenko as EVP and Chief Scientific Officer

2025-09-22

PR Newswire

Endo Presents Plantar Fibromatosis and Plantar Fasciitis Data at the American Orthopaedic Foot & Ankle Society Annual Meeting

2025-09-12

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