Quality Associate II/III, QA, Final Container Release

Grifols SA

Clayton, NC

JOB DETAILS
SKILLS
Administrative Skills, Capital Project, Change Control, Clinical Trial, Communication Skills, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Documentation, Engineering, Healthcare, International Health, Mathematics, Medical Conditions, Medical Products, Medicine, Organizational Skills, People Management, Plasma, Problem Solving Skills, Product Documentation, Product Reviews, Project Engineering, Quality Assurance, Recruiting/Staffing Agency, Regulatory Submissions, SAP, Staff Training, Standard Operating Procedures (SOP), Technical Support, Writing Skills
LOCATION
Clayton, NC
POSTED
15 days ago

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.

About the Company

G

Grifols SA

At Grifols, what we do matters

Are you passionate about making a difference in the world? At Grifols, we are pioneers in the development of therapies derived from blood and plasma. We contribute to building the future of healthcare to improve people's well-being. Since 1909, we have been defined by passion, innovation, teamwork and a sense of responsibility. Our people change lives while growing and developing into a forward-looking international company.

Your future at Grifols

At Grifols, you will be part of a growing international team of more than 23,000 people in more than 30 countries and regions with a common goal: to improve people's lives. You will contribute to developing scientific advances and providing innovative solutions for healthcare professionals and essential medicines for patients. We want to count on determined professionals who, by cultivating their talent, contribute to creating a positive impact on society.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1909
WEBSITE
https://www.grifols.com/