Job Information
Grifols Shared Services North America, Inc Sr. Quality Associate I/II, QA in Clayton, North Carolina
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
Summary:
The Senior Quality Associate I, Quality Assurance may be assigned duties and responsibilities within Quality Assurance. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc. The incumbent is an established and technically competent professional who develops and implements solutions to a variety of quality related objectives. He/she may participate on teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium complexity, developing solutions for defined problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.
The Senior Quality Associate II, Quality Assurance may be assigned duties and responsibilities within Quality Assurance. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of employees. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.
Primary Responsibilities:
Senior Quality Associate I, Quality Assurance
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.
Participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion.
Collects and analyzes data
Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
Demonstrated ability to make sound quality decisions with moderate 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.
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
Senior Quality Associate II, Quality Assurance
Use expertise to advise and influence the technical decisions of business units.
Responsible for development, maintenance and vitality of essential Grifols technologies.
Interacts regularly with members of management and as needed with regulatory officials.
Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion.
May mentor employees.
Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports.
Demonstrates high levels of values and integrity.
Follows cGMP and department safety practices.
Demonstrated ability to make sound quality decisions with minimal guidance
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
Additional Responsibilities:
Senior Quality Associate I, Quality Assurance
In addition to the duties described above the Sr. Quality Associate I, 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 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.
Additional responsibilities may include preparation of release protocols and necessary certification for new market registration and license renewal. Support changing market requirements. Maintenance of release certificates of analysis, preparation of periodic RA reports, tracking batch release status including accepted, rejected, reprocessed, and reworked batches. Managing document revisions in support of change controls, projects, continuous improvement initiatives, etc. Support IT projects related to batch release. Assist with tracking media fills and personnel training within the department.
Senior Quality Associate II, Quality Assurance
In addition to the duties described above the Sr. 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 advanced roles (such as author, reviewer, approver, 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.
Additional responsibilities may include preparation of release protocols and necessary certification for new market registration and license renewal. Support changing market requirements. Maintenance of release certificates of analysis, preparation of periodic RA reports, tracking batch release status including accepted, rejected, reprocessed, and reworked batches. Managing document revisions in support of change controls, projects, continuous improvement initiatives, etc. Support IT projects related to batch release. Assist with tracking media fills and personnel training within the department.
Knowledge, Skills, & Abilities:
Senior Quality Associate I, Quality Assurance
Excellent communication skills (written and verbal). Has basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Knowledge of current products, product specifications, different market requirements and regulations is preferred. In addition, knowledge of SAP QM is highly preferred.
Senior Quality Associate II, Quality Assurance
Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administrations) and applicable foreign regulatory agency requirements/guidelines.
Prior knowledge and experience with different products, product specifications, different market requirements and regulations is preferred. In addition, knowledge and experience of SAP QM is highly preferred.
Requirements:
Senior Quality Associate I, Quality Assurance
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.
Senior Quality Associate II, Quality Assurance
BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.
Occupational Demands:
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.
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 525580
Type: Regular Full-Time
Job Category: Quality