Sr. Quality Analyst

Sr. Quality Analyst

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 4,000+ team members worldwide, we lead with pride and purposeprioritizing 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 serves as the primary for customer inquiries, gap assessments, customer audit coordination, and inspection readiness. Additionally, the Sr. Quality Analyst serves as a primary back up for release work for finished product, batch record review, and label preparation.

Essential Functions:

• Utilize inventory management systems 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

Additional Functions:

• 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.

Department Specific/Non-Essential Functions:

• 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.

Minimum Requirements:

• Education: High School Diploma, GED, or equivalent.
• Associates of Science (AS) degree in a related field.
• Bachelors of Science (BS) or equivalent life science degree preferred.
• Experience: Minimum of three years of experience preferred in a Quality auditing and batch record review role.

Preferred Skills/Qualifications:

• 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.

Relationship With Others/Scope:

• 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. An error in judgment during audits could result in FDA citations to the company.
• 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.
• No employees directly reporting to this position.

Working Conditions:

• General normal office and meeting room conditions but must complete some routine assignments in plant and non-air conditioned production environment.
• Ability to adjust schedule as needed to accommodate production, release, shipping needs.
• Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses and any other devices or equipment as specified for the position.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides 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. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.