Senior Manager, QC Lab Operations
celgene - Phoenix, AZ

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EDUCATION/EXPERIENCE REQUIREMENTSRequires a Bachelors degree in Chemistry or related science from an accredited college or university with a minimum of 710 years related experience in a regulated laboratory, preferably a pharmaceutical laboratory environment, including 5 years of progressive management experience. Requires extensive knowledge of quality control systems, including FDA and DEA compliance standards, regulations, and guidelines. Requires excellent oral, written, presentation, organizational and leadership skills. An equivalent combination of education, experience and training may substitute.POSITION SUMMARY The Sr.

Manager, QC Laboratory Operations, is responsible for managing all aspects of QC Laboratory Operations in support of drug manufacturing and testing. This encompasses Incoming Inspection, Raw Material and Component testing, IP and FP testing as well as Stability and Complaint Testing, ESSENTIAL FUNCTIONSEnsure that department’s activities are carried out in accordance to the organization’s policies, procedures and state, federal and local laws. Ensure timely availability, reliability and accuracy of the test data. Ensure all unit staff receives training in cGMP’s SOP’s, Company Policies and safety, and that employees meet defined qualification requirements for the position to which they are assigned.

Oversee the investigation of quality problems in raw materials/components, inprocess, finished products and stability in order to analyze and propose corrective actions to prevent reoccurrence and to recommend disposition. Participate in production planning process, prepare and manage the departmental budget, and allocate human resources to support manufacturing, testing, and investigations. Review and approve laboratory data in accordance with cGMP’s and good documentation practices. Review and approve all new and revised QC chemistry related SOP’s and test methods to ensure compliance with government, submission and compendial requirements.

Review and approve protocols and reports for including but not limited to manufacturing processes, cleaning validation, stability studies, and laboratory methods. Ensure methodology and procedures are compliant with current standards, compendia and proposed revisions. Implement and measure performance metrics, goal/objectives and practices for cost effective management of allocated resources. Provide leadership, direction and guidance to direct report supervisors and department employees.

Participates in audits and assists with FDA and other regulatory agency audits and inspections. Manages incoming inspection and raw material and component testing Performs review and disposition of laboratory deviation investigation reports, ensuring all deviations are thoroughly investigated, documented, and that proper corrective action is taken. Interfaces with all other quality groups within the company on quality systems issues. Works with peers crossfunctionally to ensure compliance with and understanding of cGMPs, SOPs, and FDA s Actively participates in the department budget process and operates within established budget.

Oversees, participates and approves the interviewing, hiring and training of departmental employees; and conducts performance evaluation for direct reports. Provides support, direction and coaching to subordinate employees in the areas of training, disciplinary action, problem solving, planning and work assignment delegation. Ensures project deadlines and performance standards are established and met. Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.