Description
Description
Successfully perform all the primary activities as defined in the Q.A. I and Q.A. II job positions. Handle multiple projects. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead PMT, QWT, Kaizan or equivalent focus type group activities are required. Design, lead and perform experiments using sound scientific principles. A functional understanding of FDA, ISO and Baxter Quality systems is also required
Job Description
Team Member Name:
Job Title:
Quality Associate III
Department: (optional)
Function: (optional)
Summary: (optional)
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of this role that each account for 5% or more of the work. The incumbent will perform other duties as assigned.
Prepares for and plans audit/assessment activity for internal as well as third party inspection audits by researching background information, reviewing local & divisional procedures and previous audit results for all quality systems in a variety of facilities, functions and businesses on a global basis.
Manages assessment/audit activity as a lead auditor for at least 50% of the audits personally conducted and utilizes a team of auditor(s) to perform audits/assessments by collecting and analysing objective evidence regarding issues and risks and ensuring key quality system metrics and key process indicators are identified, analyzed, resolution plans are identified, progress is tracked and communicated to senior management on the quality systems of functions, businesses, facilities and suppliers to ensure compliance.
Evaluates corrective and preventive action responses to the assessment findings for adequacy, including root cause, timeliness as well as utilizes knowledge of internal best practices to facilitate the right corrective action. Resolves complex issues and escalates concerns through business and CCS management, as appropriate.
Represents in Industry Discussion Groups/External Benchmarking
Performs audits as needed with 10-20% domestic/international travel anticipated
Acts as a Global expert and resource on Supplier Quality issues, supplier changes, procedures, etc.
Interacts with all levels of management across functions, business units, and project teams to provide guidance and input on Supplier Quality topics. Identifies supplier requirements; helps to resolve issues in a timely manner.
Serve as primary interface and resources for division/region supplier quality resources.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Knowledge of the global Regulatory and Quality requirements for the manufacture and marketing of drugs, biologics and medical devices
Knowledge of new product development processes, requirements and issues related to the evaluation, selection and maintenance of suppliers
Knowledge of supplier quality related contract requirements
Demonstrated experience interfacing with FDA/Regulatory Inspectors
Strong leadership skills and demonstrated success in managing a team
Strong Project Management & Presentation skills
Strong technical, analytical and problem solving skills
Ability to respond to customers in a timely manner
Excellent verbal and written communication skills
Demonstrated success working with multifunctional, global teams within and external to Baxter
Excellent interpersonal/communication/influencing/negotiation skills
Ability to make quick, sound decisions with limited data
Ability to solicit feedback and information from others in an open environment
Ability to build relationships across functional boundaries at multiple levels internally and externally
Ability to look at the bigger picture and plan for the future.
Education and/or Experience:
Include the education and/or experience that is necessary to perform the job satisfactorily.
Minimum of Bachelors degree
Masters in Business Administration (MBA) is desirable
ASQ CQA certification is desirable
Minimum of 5 years of industry experience working/supporting cGMP processes