Providing sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues. Includes working with suppliers and internal resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, and monitoring suppliers implementation / effectiveness. Provides oversight and escalation for product related issues.
· Ensuring complaint execution of Quality Management Systems including but not limited to EM: change control, qualification, the approved supplier list, NC/CAPA, Quality agreements and performance monitoring.
· Provide leadership across activities associated with supplier risk identification & management, including planning and execution of supplier risk & control plan assessments and the ownership and creation of Quality Agreements.
· Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship/collection sites
· Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision
· Adaptable and flexible for other duties that may be assigned as needed
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
Human Resources Request Form. The EEOC "Know Your Rights" Poster is available
here.
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https://insightglobal.com/workforce-privacy-policy/ .
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.