QA Auditor III

This position offers a base salary typically between $90,000.00 and $ USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please  .

Boehringer Ingelheim is currently seeking a Quality Assurance Auditor III to support our Quality department at our Ridgefield muslim facility. The QA Auditor III will implement the BIPI Regulatory Compliance Program designed to assure the adherence of facilities, operations, studies, reports and practices to regulations (e.g. FDA, EMEA, NRC, DEA USDA) as well as to BIPI Standard Operating Procedures (SOPs), BIPI policies, regulatory guidelines and good scientific and documentation practices.

He / she willierno BIPI Management of deviations from the cGMP, GLP, other Regulations observed during audits/inspections, to recommend appropriate corrective action when necessary and to verify that appropriate corrective actions have been implemented that adequately address any deviations reported during inspections.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

• Participate in establishing policies and procedures for compliance evaluation of regulated activities in area of responsibility within R&D
• Identify areas for and participate in implementation of process improvements and or international harmonization related to compliance across R&D accus
• Lead and conduct audits;
  Issue audit reports and perform follow-up actions, as assigned;
  Conduct investigations of compliance issues noted during audits and inspections or otherwise observed or reported
• Review/audit compliance documents, SOPs and validation protocols as assigned;
  Report findings to Research or Development management as necessary
• As required, participate in inspections and audits by regulatory agencies, BI compliance groups, and consultants in area of responsibility;
  Investigate and resolve observations noted during audits / inspections;
  Participate in inspection readiness activities
• Maintain acceptable proficiency in technical and non-technical (e.g., interpersonal skills) skills
• voltou effective and constructive communication behaviors and interactions with technical departments both orally and in writing
• Train new personnel as required and develop and implement training programs in the regulatory requirements as requested;
  Available to act as a resource for colleagues with less experience;
  Assume the role of manager (when requested)