Sr. Quality Associate III, QC

Schedule: First Shift

Sr. Quality Associate I/II:

Position Summary:

This role is responsible for the implementation maintenance and continuous improvement of the Laboratory Information Management System (LIMS) used within the Grifols Therapeutics Quality Control (QC) department referred to internally as the Laboratory Electronic System (LES). The LES supports the transition toward a fully paperless laboratory by electronically capturing all elements of the QC testing process across multiple highcomplexity assays.

Key Responsibilities:

• Lead the design configuration and ongoing management of the LES including defining required data elements and establishing appropriate input parameters.
• Oversee validation activities associated with system updates enhancements and change implementations.
• Serve as a member of the QC computer validation team ensuring compliance with regulatory and internal validation standards.
• Support additional computerized systems within the QC environment including software validation oversight and custom field configuration.
• Act as a technical resource for troubleshooting and resolving issues related to electronic laboratory systems.
• Manage and document change controls related to software and system modifications.

Qualifications:

• Experience with electronic laboratory systems and computerized system validation.
• Working knowledge of QC laboratory test methods and workflows.
• Demonstrated experience with change control processes and software/computer validation activities.
• Strong analytical documentation and problemsolving skills.

Education and Experience Requirements by Level:

Quality Associate III QC - BA/BS - preferably in a STEM (science technology engineering or mathematics) curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience. Experience managing projects teams etc. is recommended

Sr. Quality Associate I QC- BA/BS - preferably in a STEM (science technology engineering or mathematics) curriculum and 5 yrs of relevant experience or an equivalent combination of education and experience. Experience managing projects teams etc. is recommended

Sr. Quality Associate II QC - BA/BS - preferably in a STEM (science technology engineering or mathematics) curriculum and 6 yrs of relevant experience or an equivalent combination of education and experience. Experience managing projects teams etc. is recommended.

Equivalency: Depending on the area of assignment directly related experienceor a combination of related education experience and competenciesmay be considered in place of the stated requirements. For example if a job level requires a Bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an Associates degree with 6 years of experience or a Masters degree with 2 years of experience.

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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