Quality Associate II/III, QA

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

Job summary

Grifols seeks a Quality Associate II/III for the QA Filling unit in Clayton, NC. The role supports routine tasks, documentation, training, and product release activities. Priorities may shift and some supervision of staff is possible.

The position requires a BS/BA in STEM and 2–3 years of related quality experience; SAP knowledge is a plus. This is a full-time onsite role with equal opportunity employment.

Qualifications

• QA work experience or equivalent in a regulated environment.
• Experience with quality systems such as Change Control and Documentation.
• Strong attention to detail and collaboration across teams.

Responsibilities

• Assist with batch release and final container product release.
• Collect, review, and analyze data to support quality decisions.
• Provide training and supervise colleagues as needed.
• Ensure compliance with cGMP and company SOPs.

Skills

Data analysis

SOP compliance

Training

Effective communication

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.

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 release along 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 oriented and 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.

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

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

Req ID: 546625

Type: Regular Full-Time

Job Category: TECHNICAL