Relevant college or university degree preferred. Minimum of 5 years relevant work experience
Weekend ( 3 days/week 12 hours/day)
PURPOSE AND SCOPE OF POSITION:
The Specialist is responsible for quality activities for the QA shop floor program in accordance with Celgene policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. This position will provide weekend coverage and may work off shift.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
* Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance. * Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. * Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. * Must possess an independent mindset. * Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. * Work is self-directed. * Confident in making decisions for non-routine issues. * Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. * Develops procedures. * Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned. * Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. * Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. * Understands continuous improvement and improves efficiency and productivity within the group or project. * Builds relationships internally within and with cross functional teams. * Contributes to goals within the work group. * Able to recognize conflict and notify management with proposed recommendations for resolution. * Able to prepare written communications and communicate problems to management with clarity and accuracy. * Able to effectively multi-task. * Knowledge of US and global cGMP requirements. * Excellent verbal and written communication skills.
DUTIES AND RESPONSIBILITIES:
* Perform QA shop floor activities. * Ensure manufacturing compliance with applicable procedures and batch records. * Perform real time review of manufacturing batch records. * Review manufacturing shop floor documentation. * Issue production batch records and product labels to Operations. * Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. * Must be skilled in planning and organizing, decision-making, and building relationships. * Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. * Able to effectively multi-task.
EDUCATION AND EXPERIENCE (As Applicable):
* Relevant college or university degree preferred. * Minimum 5 years relevant work experience and minimum 1 year of leadership experience * Equivalent combination of education and experience acceptable.
WORKING CONDITIONS: (US Only):
This position will provide 12 hour coverage Friday Saturday and Sunday. Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
\"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: calibrate, defect, qa, qa tech, quality, quality check, quality control, quality manager, requalification, test
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.