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Job Field: Office Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

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Manager, Quality Engineering October 30, 2012 - December 31, 2012 Location: Salt Lake City, UT Salary Range: DOE Exempt/Non-Exempt: Exempt Benefits: Yes Employment Type: Full Time Employer: Cephalon, Inc. Description: This position is responsible for providing Quality Engineering support for Operations and QC Laboratories, focusing on CAPA systems and Quality Technical operations. The incumbent will ensure that appropriate processes exist to triage, evaluate, and approve GMP investigations to ensure alignment with GMP and Supply Chain delivery requirements. Led by the Quality Engineering Manager, the group will also provide review and approvals of SOP s, Master Batch Records, Validation, and Change Control documents. Duties: All responsibilities listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. ? Responsible for providing QA support to validation activities supporting product launches and critical projects. ? Responsible for approvals of Out of Specification and Process investigations. ? Responsible for providing oversight of QC laboratory compliance. ? Responsible for leading cross functional teams to identify and implement process improvements. ? Responsible for presenting GMP documents during regulatory and partner inspections, PAI s and audits. ? Responsible for ensuring that critical Events, product and/or compliance risks and regulatory observations are reported to Site and Corporate management in a timely manner as required by Company policies/procedures. ? Responsible for ensuing consistent application of Quality Risk Management processes and techniques. ? Responsible for ensuring that corporate standards and guidance are maintained for functions managed. ? Responsible for completing all training requirements and maintaining 100% compliance with all assignments. ? Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP s), Standard Operating Procedures (SOP s) and Batch Record instructions. ? Responsible for performing additional related duties as assigned. Qualifications: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Education/Certification/Experience: ? Requires Bachelors Degree in Science/Engineering or equivalent with a minimum of 7 years relevant progressive experience in the pharmaceutical industry. ? Requires minimum 5 years experience managing technical level employees. ? Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems. ? Requires experience with the handling of deviations, investigations and CAPA s. ? Experience in Solid Dose manufacturing environment preferred. ? Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, Crystal Reports, Learning Management Systems and statistical software preferred. ? ASQ/CQE/CQA Certification preferred. Skills/Knowledge/Abilities: ? Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases. ? Manage multiple priorities and reporting requirements. ? Project management and advanced presentation skills. ? Motivate, influence and lead others with and/or without direct supervisory authority. ? Manage conflict and negotiate resolution. ? Self-directed with ability to organize and prioritize work. ? Communicate effectively with excellent written and oral communication skills. ? Interact positively and collaborate with co-workers, management and external partners. ? Detail oriented with ability to analyze information, create metrics and articulate the link

KEY REQUIREMENTS:

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