Principal Quality Associate

Principal Quality Associate

Location : NC-Clayton, US

Contract Type : Regular Full-Time

Area : TECHNICAL

Shift : Day - Monday through Friday 8 : 00am-5 : 00pm

The incumbent will be assigned duties and responsibilities within Quality Assurance to support the QA Fraction II Business Unit which provides Quality oversight for the following GT products : IGIV-C, IGSC, IGIM-C, and IGCP. In this role the incumbent will interface with plant manufacturing and support groups to execute site quality systems. Specific duties may include serving as author, reviewer, administrator or coordinator for quality systems such as Change Control, Discrepancy Management (including deviations, Product Technical Complaints and CAPAs), Quarantine, Documentation, and Annual Product Reviews as well as providing Quality input for Validation projects, Regulatory submissions and audits. The incumbent will serve as a Fraction II product line representative and be responsible for representing Quality at project meetings. The incumbent is an established and technically competent professional who develops and provides solutions / is able to influence the direction of project / quality related objectives.

The incumbent may participate on teams or projects of varying scope and is often called upon by peers for their expertise or guidance / is recognized as an authority in multiple areas. The incumbent demonstrates consistent application of technical knowledge and expertise, executes assignments of medium to complex nature, developing solutions for defined technical problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

The incumbent must have a strong knowledge of cGMPs, the ability to perform independently, and the ability to solve moderate technical problems. Knowledge of routine and non-routine assays, test method development, test method validations, Stability, product characterization, and / or manufacturing processes is preferred. A proactive philosophy, attention to detail, and good human interaction skills are essential and must have been demonstrated in previous work. The incumbent should be able to prepare reports / presentations and be able to effectively communicate information to varying levels of management.

The incumbent should be able to actively participate on teams of varying complexity. The incumbent must be a professional with moderate to high technical competence. Incumbent must have good to excellent judgement, and investigative, analytical, and organizational skills. Desired computer skills include Excel, Word and SAP. Experience with plasma products, Immune Globulin products or other biological products is a plus.

Requirements :

Sr. Quality Associate I -M8 : BS / BA degree in STEM (Science, Technology, Engineering, and Mathematics) discipline required with minimum of 5 years relevant experience, or equivalent combination of education and experience.

Sr. Quality Associate II - M9 : BS / BA degree in STEM (Science, Technology, Engineering, and Mathematics) discipline required with minimum of 6 years relevant experience, or equivalent combination of education and experience

Principal Quality Associate - M10 : BS / BA degree in a STEM (Science, Technology, Engineering, and Mathematics) discipline required with minimum of 8 years relevant experience, or 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

• 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 35 lbs. 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.

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.