Quality Associate II/III, QA, Final Container Release

Grifols; North Carolina; Sur place; USD 60 000 - 90 000; Plein temps

Résumé du poste

Grifols in North Carolina is seeking a Quality Associate II/III, QA Release. The role focuses on final container product release, data review, and compliance under cGMP.

You will perform batch related activities, train staff, and support documentation, changes, and audits in a fast-paced pharmaceutical environment.

Qualifications

• BS/BA degree in STEM and 2+ years related experience
• Minimum 3 years relevant experience for QA III
• Experience with cGMP and batch release processes

Responsabilités

• Supports routine technical tasks including documentation, training, compliance and product release.
• Collects, reviews and analyzes data related to batch releases.
• May supervise or train employees and communicate findings across levels.
• Follows cGMP and department safety practices.
• Responsible for final container product release and batch-related activities.

Connaissances

Data analysis

Documentation

Communication

Training others

cGMP compliance

Formation

Bachelor's degree in STEM

Description du poste

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/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 (QA II)

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

• Author, reviewer roles in quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation.
• 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.

Duties

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.