Sr. Quality Associate I/Sr. Quality Associate II - QA Packaging

Grifols; North Carolina; On-site; USD 65,000 - 95,000; Full time

Job summary

Grifols is seeking a Sr. Quality Associate I/II to support QA packaging operations. The role interfaces with manufacturing and support groups to ensure quality systems are executed effectively and aligned with regulatory expectations.

The incumbent will participate in change control, deviation management, CAPAs, and audits, contributing to robust quality processes while mentoring others and maintaining strong documentation standards.

Qualifications

• BS/BA in STEM with 5+ years relevant experience or equivalent
• Ability to work independently and solve moderate technical problems
• Experience in Quality Assurance and packaging processes is a plus

Responsibilities

• Provide QA oversight for the Packaging Business Unit.
• Interface with plant manufacturing and support groups to execute site quality systems.
• Prepare/represent QA input for validation projects, regulatory submissions and audits.
• Act as author/reviewer/coordinator for Change Control, Deviation Management, CAPAs, and Quarantine.
• Train others and provide guidance on quality processes.

Skills

cGMPs knowledge

Independent work

Quality oversight

Verbal/written communication

Education

BS/BA STEM degree

Tools

SAP

Excel

Word

Job description

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.

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

Sr. Quality Associate I/ Sr. Quality Associate II

The incumbent will be assigned duties and responsibilities within Quality Assurance to support the QA Packaging Business Unit which provides Quality oversight. 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 providing Quality input for Validation projects, Regulatory submissions and audits. The incumbent will be responsible for representing Quality at project meetings. The incumbent is an established and technically competent professional who develops and provides solutions and 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 packaging processes is recommended. 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 competency. Incumbent must have good to excellent judgement, and investigative, analytical, and organizational skills. Desired computer skills include Excel, Word and SAP. Experience in different aspects of pharmaceutical business is a plus.

Requirements

M8: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.

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

Work is performed in an office and manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office 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.

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

Learn more about Grifols