Quality Associate II / Quality Associate III, QA Release
Grifols, S.A, Clayton, NC, United States
Quality Associate II / Quality Associate III, QA Release
Location: NC-Clayton, US
Contract Type: Regular Full-Time
Area: OPERATIONAL TECHNICAL AREA
The Quality Associate II/III provides routine technical support for various tasks such as documentation, training, compliance, product release, and scheduling. The candidate may coordinate work assignments, train other employees, execute medium‑complexity assignments, and develop solutions to defined problems for Quality Assurance while requiring minimal supervision.
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 (SOP, etc.) or practice.
May supervise or train employees.
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 II):
May perform roles such as author or reviewer in quality systems including Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.
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 (QA III):
May perform roles (author, reviewer, administrator, coordinator) in quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, Annual Product Reviews and 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 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.
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Location: NC-Clayton, US
Contract Type: Regular Full-Time
Area: OPERATIONAL TECHNICAL AREA
The Quality Associate II/III provides routine technical support for various tasks such as documentation, training, compliance, product release, and scheduling. The candidate may coordinate work assignments, train other employees, execute medium‑complexity assignments, and develop solutions to defined problems for Quality Assurance while requiring minimal supervision.
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 (SOP, etc.) or practice.
May supervise or train employees.
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 II):
May perform roles such as author or reviewer in quality systems including Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.
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 (QA III):
May perform roles (author, reviewer, administrator, coordinator) in quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, Annual Product Reviews and 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 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.
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