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About Anchor Technical Services:
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Full service technical staffing firm specializing in the following:
IT
Engineering
Scientific
Communications
Click here to go to the Anchor Technical Services website.
For details about Anchor Technical Services, click here.
About the Opportunity/Requirements:
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You must act as first responder for any quality issues; manage and guide the response, actively pursuing resolution. Review and issue the final approval on various procedural documents and reports. As the Senior QA Engineer, you must ensure regulatory and procedural compliance throughout all activities. This position represents the site and corporate QA in interactions with other departments.
• You must act as the first responder for any quality issues and actively pursue fast, compliant closure and documentation of all non-conformance reports (NCRs) and corrective and preventative action (CAPA) implementations.
• Act as the final QA reviewer and signatory on Investigations and CAPA documentation, SOPS, protocols, and reports related to projects.
• Provide quality assurance (QA) input and documentation to support quality and compliance decisions as well as material disposition decisions.
• Participate in quality and process improvement initiatives by acting as a QA representative on project teams and also by representing corporate perspective.
• Manage completion of tasks assigned to QA; provide quality and compliance expertise for the team as necessary.
• Support, participate in, and approve compliance–critical efforts including change controls and validation processes.
• Perform trend analysis and report results for key quality metrics.
• Provide support for continuous improvement initiatives.
• Manage QA support for new product introductions at the site.
• Manage QA support for site quality systems such as Investigations, Corrective and Preventive Actions, and Customer Inquiries.
• Manage and Support regulatory/client audits of the site.
• Bachelor’s degree in Science, Engineering, or Pharmaceutical Studies
• Minimum of 7 years quality assurance experience in a pharmaceutical company
• ASQ CQE desired
• Clear problem-solving and decision-making skills
• Basic knowledge of MS Word, Excel, Access and other lab-related software
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