Quality Associate II/III, QA, Final Container Release

Grifols Shared Services North America, Inc; Clayton (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Grifols Shared Services North America, Inc. is seeking a Quality Associate II/III for Day shift in North Carolina. The role focuses on routine QA release tasks, data review, documentation, and adherence to cGMP and safety practices.

The position may involve training other staff, coordinating work, and supporting QA systems such as Change Control and Batch Release. BS/BA in STEM with 2+ years QA experience is preferred.

Qualifications

• BS/BA in a STEM field preferred with 2+ years QA experience or equivalent combination.
• Experience with cGMP and quality systems is required.
• Ability to review and analyze data, write and follow SOPs.

Responsibilities

• Release final container product batches.
• Support Change Control, Discrepancy Management and Documentation activities.
• Train or supervise colleagues as needed within a QA team.
• Communicate effectively across levels and support management decisions.

Skills

Quality Assurance

Documentation

Attention to detail

Communication

Education

BS/BA in STEM

Tools

SAP QM

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.

Shift: Day

Quality Associate II / Quality Associate III, QA Release

Summary:

The Quality Associate II/II 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.

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.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

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.

Regular Full-Time

OPERATIONAL TECHNICAL AREA