Sr. Quality Associate I/II/Principal Associate, Compliance

Company: Grifols
Location: Clayton
Posted on: March 18, 2023

Job Description:

The Quality Compliance Auditor may be assigned various duties and responsibilities including but not limited to:

• Auditing, data analysis, coordination and/or review of purchase specifications, standard operating procedures, quality agreements, failure investigations, change control requests, review of manufacturing or testing reports, etc.
• The incumbent requires minimum supervision, and is a technically competent professional who has demonstrated excellent organizational and leadership skills, and capable of independently developing and implementing solutions for a variety of quality related objectives.
• He/she must have excellent written and verbal communication skills, and may lead multi-discipline teams on projects of medium to high complexity.
• The employee communicates with employees at all levels, including other Grifols sites, suppliers/customers, and regulatory agencies.
• He/She demonstrates consistent application of technical knowledge in executing assignments, and develops solutions for defined problems.
• The employee may train other employees. As appropriate, this employee may serve as authorized delegate for the department supervisor.
• The primary responsibilities of the position include the following: plan, schedule, lead, and execute, or otherwise participate in routine and directed internal audits utilizing knowledge of US and foreign regulations, guidances, and industry standards for pharmaceutical and medical device manufacturing; review/analyze data, prepare and review reports; follow-up on audit observations and/or verify corrective actions associated with internal and external audits or other sources, through collaboration with manufacturing and QA/QC for improvement of Quality Systems, etc.: support site regulatory and customer audits, perform audit follow-up activities by requesting responses, tracking the status of corrective actions.
• The incumbent may also lead/participate in supplier management external audits and other supplier quality activities; author, edit, and/or publish SOPs, purchase specifications, and other documents as directed using company prescribed computer software and systems.
• The position also performs routine surveillance of current regulatory changes and expectations and incorporates them into the working operations of the company.
• Perform other duties as assigned by Quality Compliance management. Required Knowledge, Skills and Abilities: The candidate must possess in-depth knowledge of FDA, EU, PIC/S, and ICH cGMPs, and must have demonstrated application of such regulations and guidances in robust Quality Systems. Excellent communication skills (written and verbal) are required. The successful incumbent must have demonstrated a high degree of organization and follow up skill set. Required Experience/Education: Sr. Quality Associate I, Compliance (M8) / Sr. Quality Associate II, Compliance (M9), Principle Quality Associate (M10): BA/BS required preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 5 years (M8), 6 years (M9), or 8 years (M10) of relevant experience. *Must possess current ASQ auditor certification: Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) or equivalent auditor certification from a recognized professional certification authority. Must possess adequate proficiency in the use of Word and Excel computer software. Working knowledge of SAP functionality is desirable. Experience/Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related experience and/or competencies may be considered in place of the stated competencies. Work Hours: This position is routinely scheduled to work Monday through Friday during dayshift. Work on other shifts or days may be required and/or assigned for specific periods by management, including the requirement to travel during non-dayshift hours for work-related projects/duties. Overtime may be required as needed. 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 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. EEO Minorities/Females/Disability/Veterans

Keywords: Grifols, Raleigh , Sr. Quality Associate I/II/Principal Associate, Compliance, Other , Clayton, North Carolina