Quality Associate II​/III, QA, Final Container Release

Quality Associate II/III, QA, Final Container Release

Location:

NC-Clayton, US

Contract Type:
Regular Full-Time

Area: OPERATIONAL TECHNICAL AREA

Shift: Day

The Quality Associate II/III provides routine technical support for various tasks such as documentation, training, compliance, product release, scheduling, etc. The primary responsibility of this position is final container product release along with other responsibilities listed below. The candidate will perform batch related activities and meet cycle time releases. Execution of assignments of medium complexity and development of solutions to defined problems for Quality Assurance.

The role requires minimal supervision.

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

• Roles such as author, reviewer in quality systems:
  Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, plus providing Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.

• 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.

• Roles such as author, reviewer, administrator, or coordinator in all quality systems:
  Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews, plus providing 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.

QA work experience, experience reviewing BPRs. Possess excellent organizational skills, communication skills, detail oriented and very efficient.

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.