Sr Quality Specialist

Endo • Raleigh, NC

2d • Hybrid

About The Position

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day. The Sr. Quality Analyst has responsibility for Product Release and Maintenance of Monthly Quality Metrics and Daily Notification to Management. Additionally, the Sr. Quality Analyst will provide support for customer inquiries, gap assessments, customer audit coordination, and inspection readiness. batch record review, and label preparation as assigned. They will serve as secondary back-up for batch record review and label preparation as needed.

Requirements

• Competency in MS Word, Excel, and Adobe is required.
• Minimum 5 years’ experience in QA or a pharmaceutical manufacturing environment, other relevant experience may be considered.
• Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP.
• Thorough knowledge of quality procedures and GMPs to appropriately audit and perform records functions associated with site compliance to FDA regulations.
• Good project management, problem solving, team building, and negotiation skills.
• Strong technical, oral, and written communication skills.
• Able to plan and execute tasks on multiple projects simultaneously.
• Diligence, organization, time management, and effective communication are needed for this position.
• A high degree of concentration is required to prevent mix-up and consequent quality release errors.

Nice To Haves

• B.S. degree in equivalent life science preferred, other degrees may be considered with relevant experience.

Responsibilities

• Utilize inventory management systems and other associated quality systems to ensure proper release of product for the Raleigh manufacturing site.
• Function as a Primary back-up for the Raleigh site gap assessments and customer inquiries and coordinates organization of required documentation for GMP customer requests with guidance from manager.
• Provide support for various elements of Quality including but not limited to the following: GMP NEO Training, Annual Product Review, Management Review, Audits, Product Complaints, CAPA, and Change Control.
• Maintenance of the Site Internal Audit Program.
• Function as a secondary 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.
• Function as secondary back up for label preparation. This includes programing label changes and adding 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.
• Issuing final product labels and batch records to production.
• Assist as needed with archival of batch records to including but not limited to, batch record scanning, documentation error tracking and corrections, and label reconciliation.
• Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both QA and QC as well as filing.
• Provide support to investigations, both exceptions and OOSs, to support product disposition.
• Corresponds with customers via routine customer inquiries.
• Provide 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.
• Provide administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines.

Benefits

• Equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior