Quality Associate II/III - Fraction/QA
NC-Clayton, US
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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. |
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Summary:
The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fraction II business unit. Duties and responsibilities include support of the Quality Assurance Fr II BU related to release of Initial Bulks, Sterile Bulks, and Weekly/Monthly/Quarterly packets.
Responsibilities include:
- Collects, reviews and may analyze data
- Makes decisions within a well-defined area that may influence the department goals
- Coordinates work assignments
- Addresses and resolves problems according to written procedures (eg. SOP) or practice
- Communicates effectively and promptly
- Demonstrates high levels of values and integrity
- Follows cGMP and department safety practices
- May train other employees
- Other duties assigned by manager/supervisor
Additional responsibilities may also include:
- Execute assignments of medium complexity
- Develop solutions to defined problems
- Collect, review and analyze data to generate department reports
- Communicate effectively at all levels of the organization, supporting department objectives and management decisions
- Perform roles and/or tasks associated with one or more Quality System function such as Batch Release, SAP Quality Module, Documentation, Change Control, Discrepancy Management, Quarantine, and Annual Product Reviews
- May also provide Quality support for validation, capital projects, ETPs, Regulatory submissions, or other studies
Knowledge, Skills, and Abilities:
Successful candidates should have excellent communication skills (written and verbal), attention to detail, and the ability to be flexible and adapt to sudden changes in priorities and deadlines. He/she must have the ability to multi-task, work well under time constraints, and demonstrate consistent application of technical knowledge. He/she should also have basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Preference will be given to candidates with knowledge of Fraction II processes and/or experience reviewing and approving others’ work such as batch records, test data, reports etc.
Required Education
Quality Associate II (M06): BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience.
Quality Associate III (M07): BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or equivalent combination.
Benefits:
We offer a comprehensive package of benefits including medical, Paid Time Off (PTO), annual bonus, pharmacy, dental, vision, disability insurance, life & AD+D insurance, 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years -- we're growing, and you can grow with us!
Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.
Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton