Quality Associate/ Sr. Quality Associate Materials Evaluation Coordinator
NC-Clayton, US
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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. |
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Quality Associate/SR QA Associate Materials Evaluation Coordinator
Hours: 2nd Shift
Position Summary:
The Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator performs in the Packaging area as a Quality representative for sampling, auditing, and making
Quality decisions. In this area, the Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator audits unlabeled final container vials, media, syringes and finished product batches using designated ANSI sampling plans.
Additionally, the Packaging Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator responsibilities include: reserve sampling, post-pack identity sampling, packaging commodity verification and
reconciliation, line clearance verification, and stability sample inspection. The Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator inspects product final container reserve samples according to approved standard operating procedures. Decisions made by Quality Associate/Sr. Quality Associate Materials Evaluation Coordinators have major compliance and monetary implications for Grifols.
Primary Responsibilities:
- Evaluate critical quality attributes (visual, dimensional, functional), of unlabeled final containers and finished product, and execute required SAP transactions on all quality audits of material inspected and packaged at the facility.
- Must stay abreast of the rapidly changing requirements of various regulatory agencies. New policy changes from these groups has a definitive, immediate impact on Materials Evaluation responsibilities and release of material to production.
- Responsible for performing quality verifiation of component issuance, vial etch, production order picklists of products packaged at the Clayton site. Non-verification of primary and secondary packaging components could be means for material or plasma product recall and will impact product market availability.
- Must possess extensive knowledge of cGMP, company specifications and packaging operating procedures.
- Quality Associate/ Sr. Quality Associate Materials Evaluation Coordinator will serve as trainers to new employees in all aspects of this position and are considered to be a Subject Matter Expert (SME).
Knowledge, Skills & Abilities:
The incumbent must possess keen assessment skills and the ability to distinguish insignificant deviations from significant deviations that jeopardize the integrity of the product to be released. The incumbent must be able to learn and understand the concepts of statistical sampling used in daily activities. Computer skills are required. Must be able to read and understand technical drawings. Effective communication skills, including proper grammar, are essential in order to report (both in writing and verbally) data and product impact. Must keep neat, accurate, and complete records of material evaluations and release activities performed. Tactful human relation’s skills are essential to achieve cooperation between business partners and customers.
Incumbent must have prior inspection experience (i.e. manufacturing components, packaged goods, etc.)
Education:
Requires minimum of an Associates degree with an emphasis in sciences or mathematics or an equivalent combination of education and experience is acceptable.
Experience:
A minimum of one year of related experience, preferably as a packaging inspector or in Materials Evaluation, is required for the Quality Associate/ Sr. Quality Associate Materials Evaluation position.
Incumbent must have prior inspection experience (i.e. manufacturing components, etc.)
Equivalency:
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. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.
Occupational Demands:
When working with raw material chemicals and product, the incumbent must be able to wear all required safety equipment such as protective eyewear, garments and gloves and able to work with limited supervision. Must demonstrate initiative and have the ability to defend a decision based on specifications and procedures. In addition the incumbent must have near vision correctable to at least 20/20 in one eye and 20/40 in the other eye, have no color blindness, excellent color and depth discrimination, and be able to lift up to 50 lbs. The incumbent must be able to successfully pass the certification requirement for product final container visual inspection.
Work is performed in an office and a 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 equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 10 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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton