Sr. Quality Associate I/II

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: 1st - M-F 8:00am - 4:30pm

Sr. Quality Associate I/II - Summary:

The Sr. Quality Associate I/II will primarily serve as a Quality Systems technical specialist as part of the QA Fractionation business unit.  He/She will develop and implement solutions to a variety of quality related objectives to support department goals including executing assignments of medium complexity and developing solutions for defined problems.  The Sr. Quality Associate I/II will also perform manufacturing record review for Pooling through Fractionation Batch Release, Contract Intermediate Batch Release, Quarantine and other related Quality functions to support department cycle time goals and objectives. He/She will provide leadership and guidance to others, including training other employees and representing the Quality unit when necessary.

Responsibilities:

• Consults with management to develop and implement solutions for achieving quality related objectives.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Uses expertise to make independent decisions within defined areas of responsibility and may influence technical decisions of complex projects and/or business units.
• Participates on, and may lead, multi-disciplined project teams.  Also advances technical project proposals to senior management, following through to successful completion.
• Collects and analyzes data
• Prepares, reviews, and in some cases approves, SOP revisions, technical reports in DCM, Change Control Requests, Incident Tracking System entries and investigation reports. 
• Demonstrated ability to make sound quality decisions with moderate to minimal guidance
• Prepares, reviews and/or approves Incident Tracking System entries and investigation reports.
• Demonstrates high levels of values and integrity.
• Follows cGMP and department safety practices.
• May mentor employees based on experience
• Additional duties may include roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management/CAPA, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, Risk Assessments, 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. May also interact regularly with members of management and as needed with regulatory officials, and be responsible for development, maintenance and vitality of essential Grifols technologies.

Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.

Knowledge, Skills, and Abilities: 

• Demonstrated consistent application of technical knowledge and expertise. 
• Excellent communication skills (written and verbal) and attention to detail.
• Knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. 
• Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and lead/drive any necessary changes.

Required Experience:

Successful candidates must be qualified to perform an advanced, independent role (such as author, reviewer, coordinator and/or approver) for one or more Quality Systems within defined area of responsibility such as Batch Release, SAP Quality Module, Quarantine, Discrepancy Investigations, CAPA, Change Control, Documentation, Annual Product Reviews, Compliance Audits, and Risk Assessments.

Required Education

Sr. Quality Associate I, QA (M08):  BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.

Sr. Quality Associate II, QA (M09): BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.

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. 

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, 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! 

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 

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