Senior Quality Assurance Engineer
In this role the ideal candidate will provide engineering expertise to the QA/QC, production and technical organizations to ensure the following: compliance to all cGMPs in issues that affect marketed products and/or their raw materials, APIs, excipients or components. Responsibilities include:
· Collaborate with full range of personnel in manufacturing and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.
· Consult with a range of internal and external clients and collateral contacts to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet multiple technical, regulatory and business requirements.
· Review and approve protocols, validation documents, investigations and procedures.
· Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
· Provide engineering leadership and technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Contributes to data and information collection.
· Act as engineering technical resource with the FDA and other government agencies during site inspections.
· Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
· Approve change controls and act as chairperson for Change Control Board meetings.
· Conduct Pre-op GMP checks.
· Represent QA in a range of team meetings, processes and initiatives.
The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
· BS/BA degree in a scientific discipline with 5 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
· Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays and, even in adverse weather conditions.
· Handling of and/or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
To apply go to: http://www.candidatemanager.net/Lantheus/lan_iframe.html
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