Sr. Quality Associate , QA, Final Container Release

Sr. Quality Associate I, QA, Final Container Release

Location:

NC-Clayton, US

Contract Type:
Regular Full-Time

Area: TECHNICAL

Would you like to join an international team working to improve the future of healthcare? 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

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, and related activities. 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 expertise or guidance. Demonstrates consistent application of technical knowledge and 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.

• 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-disciplinary project teams. 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.
• Demonstrates 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 may apply.

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 registrations 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.

Excellent communication skills (written and verbal). Basic knowledge/understanding of domestic (e.g., Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Knowledge of current products, product specifications, different market requirements and regulations is preferred. Knowledge of SAP QM is highly preferred.

BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 5 years relevant experience, or an 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°F in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment such as protective eyewear, garments and gloves is required. Work is performed sitting or standing for 2-4 hours per day.

Frequent hand movements with the fingers, hands, and wrists. Ability to make precise coordinated movements and to grasp and manipulate objects. Light to moderate lifting up to 35 lbs.…