Sr. Quality Associate I, Quality Assurance

NCBiotech; Clayton (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Grifols is seeking a Sr. Quality Associate I in Clayton, NC to serve as a Quality Systems technical specialist.

The role includes developing solutions to quality objectives and performing manufacturing record reviews for Pooling through Fractionation Batch Release, among other QA functions. The candidate will support investigations, CAPA, change control, validation and system risk assessments while ensuring compliance with cGMP and regulatory requirements.

Qualifications

• BS/BA in STEM with at least 5 years of relevant experience.
• Experience in QA, investigations, CAPA, validation and related quality activities.
• Strong written and verbal communication skills.
• Knowledge of FDA/regulatory guidelines and quality systems.

Responsibilities

• Consult with management to develop and implement quality solutions.
• Support deployment of technical resources to meet annual goals.
• Make independent decisions within defined areas of responsibility.
• Participate in cross-functional project teams and drive proposals to completion.
• Collect and analyze data to support quality decisions.
• Prepare and review SOP revisions, technical reports, and change controls.
• Assist in incident tracking and investigation reporting.

Skills

Quality systems

Data analysis

Communication skills

Regulatory knowledge

Multi-tasking

Education

BS/BA in STEM

Tools

SAP

SAP Quality Module

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Shift

First Shift

The Sr. Quality Associate I Quality Assurance will primarily serve as a Quality Systems technical specialist as part of the QA NFF/NFB business unit. He/She will develop and implement solutions to a variety of quality related objectives to support department goals including executing assignments of medium complexity and developing solutions for defined problems. The Sr. Quality Associate I will also perform manufacturing record review for Pooling through Fractionation Batch Release and other related Quality functions.

Responsibilities

• Consults with management to develop and implement solutions for achieving quality related objectives.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Uses expertise to make independent decisions within defined areas of responsibility.
• Participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion.
• Collects and analyzes data
• Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
• Demonstrated ability to make sound quality decisions with moderate guidance
• Prepares, reviews, and/or approves Incident Tracking System entries and investigation reports
• Demonstrates high levels of values and integrity.
• Follows cGMP and department safety practices.
• Additional duties may include roles (such as author, reviewer, administrator, or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit meetings and project meetings.

Knowledge, Skills, and Abilities

Demonstrated consistent application of technical knowledge and expertise. Excellent communication skills (written and verbal) and attention to detail. Knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Ability to easily multi‑task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement.

Knowledge of fractionation and associated manufacturing processes is a plus, although not required.

Required Experience

The successful candidate must demonstrate consistent application of their technical expertise and be able to perform an independent role (such as author and reviewer) for Investigations, CAPA, Change Control, Documentation, Validation, System Impact & Risk Assessments, and Process Improvement.

Experience supporting Continuous Improvement and Capital Projects including commissioning & validation, system & component impact assessments, risk assessments, process validation, and cleaning validation is also required.

Required Education

Sr. Quality Associate I, QA (M08): BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.

Equal Employment Opportunities

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location

NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID

540207

Type

Regular Full-Time

Job Category

TECHNICAL