Principal Quality Associate, QC General Computer Systems

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.

Hours: Day Shift - 8:00 am to 4:30 pm

 

Sr. Quality Associate I/II  / Principal Quality Associate, QC General Computer Systems 

 

 

The person in this role will primarily support Quality Computer System Validation for the QC Laboratories. The incumbent is a professional with high technical competency who leads project or discipline teams. Can make quality decisions for the team.  The employee influences the direction of complex projects and communicates with all levels of employees.  Can identify continuous improvement opportunities and drive the change and assess impact to other areas of the business. 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.  Serves as delegate to the manager. 

Note: experience with implementing computer software programs and/or experience completing computer software validation activities is a requirement. 

 

Responsibilities:

 

• Serve as Quality Control SME and consultant for analytical software validation for GT.
• Write and Perform software test plan validations for associated QC test systems.
• Work with customers to ensure validation deliverables are produced during projects.
• Actively participate in cGXP/CSI process to ensure systems inventory is accurate and up to date by partnering with system owners to complete appropriate documentation.
• Assist and ensure analytical software systems are configured to meet security and CFR Part 11 requirements for designated Quality systems.  This includes development, maintenance, training, validation, SOP(s).
• Support any compliant requirements of FDA audits, internal and external audits and regulatory affairs commitments.
• Support data integrity initiatives associated with MHRA, CFR Part 11, EU Annexes 11 and 15.
• Support Change Control requests for laboratory computer systems.
• Support any new product/market growth and existing projects as required for computer validation through quality consulting and timely review/approval of computer validation documents.
• Demonstrated ability to independently make sound quality decisions.
• Demonstrated ability to influence decisions makers in other departments
• Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

 

Additional Responsibilities:

 

In addition to the duties described above the Principle Quality Associate, Quality Control 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 Control input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.  Responsible for representing Quality Control manager at business unit meetings, and project meetings. 

 

Knowledge Skills and Abilities:

 

Excellent communication skills (written and verbal).  Demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be able to work independently. Must have extensive experience in software validation for test systems (minimum 5 years).

 

Principal Quality Associate, QC -BA/BS degree in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS is required. Depending on the area of assignment, directly related experience or a co