Quality Associate II/III, QA, Final Container Release

Grifols, S.A; Clayton (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Grifols, S.A. seeks a Quality Associate II/III for final container release in Clayton, NC. The role provides routine technical support for documentation, training, compliance, and product release with minimal supervision.

Responsibilities include data review and batch release in a cGMP environment, with opportunities to contribute to quality systems and validation projects. QA II/III requires strong organizational skills, data analysis, and effective communication.

Qualifications

• QA work experience with batch record review and release
• Strong organizational and communication skills
• Familiarity with quality systems and SOPs

Responsibilities

• Final container product release and related QA tasks
• Review data and documentation to support batch release
• Assist in Change Control, Discrepancy Management, and Batch Release
• Coordinate with cross-functional teams to meet cGMP standards
• Train or supervise teammates as needed
• Follow safety practices and company policies

Skills

QA experience

cGMP knowledge

Data analysis

Education

BS/BA in STEM

3+ years QA experience

Job description

Quality Associate II/III, QA, Final Container Release

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: OPERATIONAL TECHNICAL AREA

Shift: Day

Position Summary

The Quality Associate II/III provides routine technical support for various tasks such as documentation, training, compliance, product release, scheduling, etc. The primary responsibility of this position is final container product release along with other responsibilities listed below. The candidate will perform batch related activities and meet cycle time releases. Execution of assignments of medium complexity and development of solutions to defined problems for Quality Assurance. The role requires minimal supervision.

Primary Responsibilities – QA II

• Collects, reviews, and may analyze data.
• Makes decisions independently within a well‑defined area.
• Addresses and resolves problems according to written procedure (SOP, etc.) or practice.
• May supervise or train employees.
• Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
• Demonstrates high levels of value and integrity.
• Follows cGMP and department safety practices.

Additional Responsibilities – QA II

• Roles such as author, reviewer in quality systems: Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, plus providing Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.

Primary Responsibilities – QA III

• Develops alternative solutions to problems, handles complex problems independently.
• Demonstrates strong technical expertise and ability to adapt to changing circumstances.
• Collects, reviews, and may analyze data.
• May supervise or train employees.
• Makes decisions with designated assignments that influence the goals of the department.
• Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
• Demonstrates high levels of value and integrity.
• Follows cGMP and department safety practices.

Additional Responsibilities – QA III

• Roles such as author, reviewer, administrator, or coordinator in all quality systems: Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews, plus providing 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.

Experience, Skills and Knowledge

QA work experience, experience reviewing BPRs. Possess excellent organizational skills, communication skills, detail oriented and very efficient.

Education and Experience Requirements

QA II: BS/BA degree preferably in a STEM (Science, Technology, Engineering, or Mathematics) and a minimum of 2 years of related experience, or equivalent combination of education and experience.

QA III: BS/BA preferably in a STEM degree with minimum of 3 years relevant experience, or equivalent combination of education and experience.

Equal Employment Opportunity

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.