Quality Associate II/III, QA

Grifols, S.A; Clayton (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Grifols, S.A in Clayton, NC is seeking a Quality Associate II/III for the QA Filling unit on the Day Shift. The role provides routine technical support across documentation, training, compliance, and product release, and may supervise or train staff.

You will perform batch-related activities, manage data reviews, and ensure adherence to cGMP practices. The position offers growth within a global healthcare company with a focus on quality and regulatory excellence.

Qualifications

• BS/BA in STEM and related QA experience required for QA II/III.
• Familiarity with quality systems and regulatory practices.
• Ability to train or supervise staff and manage data.

Responsibilities

• Final container product release and related batch activities.
• Review and analyze data, ensure timely releases.
• Coordinate training and supervise employees as needed.
• Maintain cGMP compliance and quality documentation.

Skills

Data analysis

SOP compliance

cGMP knowledge

Training/coaching

Communication

Education

BS/BA in STEM

BS/BA in STEM with 3+ years (QA III)

Tools

SAP

SAP Quality Module

Job description

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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.

Schedule: Day Shift

Quality Assoc II/III, QA - QA Filling Business Unit

Summary:

The Quality Associate II/III provides routine technical support for various tasks (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. He/she may be responsible for coordinating work assignments and training other employees. Execute assignments of medium complexity and develop solutions to defined problems for Quality Assurance. Fully qualified professional who requires minimal supervision.

Primary responsibility of this position is final container product releasealong with other responsibilities listed below. The candidate will be expected to perform batch related activities and meet cycle time releases. He/she must be aware that priorities may change frequently.

Primary responsibilities for QA II role:

• Collects, reviews, and may analyze data.
• Makes decisions independently, but within a well-defined area.
• Addresses and resolves problems according to written procedure (i.e. 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:

In addition to the duties described above in the Quality Associate II, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned:

Responsibilities may include roles (such as author, reviewer) in quality systems such as Change Control,

Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects, capital engineering

projects, clinical studies, stability studies, ETPs, and Regulatory submissions.

QA III

Primary responsibilities for QA III role:

• 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:

In addition to the duties described above the Quality Associate III, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned:

Responsibilities 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.

Experience, Skills, and Knowledge:

QA work experience, experience reviewing BPRs.Possess excellent organizational skills, communication skills, detail orientedand is 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.

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.