Quality Associate IIIII, QA, Final Container Release
Clayton, OH - USA
Job Summary
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 releasealong 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.
Required Experience:
IC
About Company
Explore Grifols' comprehensive, innovative and patient-centric biopharma and healthcare solutions.