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Grifols Shared Services North America, Inc Supervisor III, Quality-QC/Sr. Supervisor, Quality-QC in Clayton, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

The Supervisor III, QC / Sr. Supervisor, QC will supervise and oversee all aspects of a group of employees. He/she will manage the daily functions of the group as well as guide assay performance and replacement, test method development/validation/troubleshooting. The selected candidate will establish suitable standard and guidance for the QC test lab, and monitor global compendia and ICH validation status. The incumbent will also provide expertise and knowledge in Pharmaceutical Microbiology to aid and meet facility and departmental objectives and goals.

Specific duties:

  • Coordinate, perform (hand on), or assist in the development, validation, trouble-shooting, and analytical support of equipment and test methods that support the Quality Control Microbiology, Environmental Assurance, and Sterility laboratories.

  • Preparation or review of assay discrepancy and conduct investigations.

  • Lead teams or projects and collaborate with Production and other Quality Units (PQM).

  • Ensure training of employees and also serve as SME for laboratory assays and act as a resource for laboratory staff.

  • Provide accountability and responsibility for project proposals, execution, and timely delivery.

  • Prepare, review or approve SOP revisions, Change Control Requests, and other departmental-related documents pertaining to main focus of responsibilities.

  • Demonstrate high levels of value and integrity.

  • Strong verbal and written communication skills

  • Strong problem-solving and troubleshooting skills

  • Strong capabilities in experimental design and execution and data interpretation.

Requirements:

Hand on experiences on biology test method validations, such as: sterility, LAL, Bioburden, Disinfectant efficacy, TOC, microbe identification and others. Must be able managing the group immediately without additional training due to the urgent projects. Supervisory and/or demonstrated leadership experience is required.

Supervisor III, QC: PHD in a Life Sciences or relevant degree with minimum of 2 years relevant experience / MS in a Life Sciences or relevant degree with minimum of 4 years relevant experience / BS in a Life Sciences or relevant degree with minimum of 6 years relevant experience.

Sr. Supervisor, QC: PHD in a Life Sciences or relevant degree with minimum of 4 years relevant experience / MS in a Life Sciences or relevant degree with minimum of 6 years relevant experience / BS in a Life Sciences or relevant degree with minimum of 8 years relevant experience.

Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. Able to communicate 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. Frequently interacts with others, relates sensitive information to diverse groups.

EEO/Minorities/Females/Veterans/Disability

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 80487

Type: Regular Full-Time

Job Category: Quality

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