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 combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Note: experience with implementing computer software programs and/or experience completing computer software validation activities is a requirement. 

Sr. Quality Associate-BA/BS degree in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience. A minimum of a BA/BS is required. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Note: experience with implementing computer software programs and/or experience completing computer software validation activities is a requirement. 

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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.  We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton 

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