Quality Associate II/III, QA (Packaging)

Grifols, S.A; Clayton (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Grifols, S.A. in Clayton, NC is seeking a Quality Associate II/III for QA Packaging to provide routine technical support, data review, and scheduling within a cGMP-compliant packaging environment.

The role supports product release and training of staff on quality processes. QA II/III requires a STEM BS/BA and 2–3 years of related experience, with strong data analysis, organizational, and communication skills.

Qualifications

• QA II requires a STEM BS/BA and at least 2 years of related experience.
• QA III requires a STEM BS/BA and at least 3 years of related experience.
• Strong organizational and communication skills with attention to detail.

Responsibilities

• Collects, reviews, and may analyze data.
• Makes decisions within a well-defined area.
• Addresses and resolves problems according to SOP or practice.
• Communicates effectively and promptly, supporting department objectives.
• Follows cGMP and department safety practices.
• Other duties as assigned.

Skills

QA work experience

Data analysis

Communication skills

cGMP knowledge

Education

BS/BA in STEM

Tools

SAP

SAP Quality Module

Documentation systems

Job description

Quality Associate II/III, QA (Packaging)

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: TECHNICAL

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 Associate II

The Quality Associate II, Quality Assurance for QA Packaging 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 of other employees.

Primary responsibilities for role:

• Collects, reviews, and may analyze data.
• Makes decisions within a well-defined area.
• Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.
• Communicates effectively and promptly, supporting department objectives and management decisions.
• Demonstrates high levels of values and integrity.
• Follows cGMP and department safety practices.
• Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

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

Quality Associate Ill

The Quality Associate Ill, Quality Assurance for Packaging QA demonstrates consistent application of technical knowledge and expertise (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. Executes assignments of medium complexity and develops solutions to defined problems for Quality Assurance. He/she may be responsible for coordinating work assignments, training other employees. Fully qualified professional who requires minimal supervision.

Primary responsibilities for role:

• Develops alternative solutions to problems
• Demonstrates strong technical expertise and ability to adapt to changing circumstances.
• May 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 values and integrity.
• Follows cGMP and department safety practices.
• Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

In addition to the duties described above the Quality Associate Ill, 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.

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.