Celgene Supervisor, Development QA, CAR-T in Warren, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- PURPOSE AND SCOPE OF POSITION:
The Supervisor Dev QA is primarily responsible for assigning batch records reviews to Specialist Dev QA and proving batch review metrics in addition to batch records reviews to ensure that the records meet cGMPs and submission requirements. The Supervisor QA also has additional responsibilities to ensure that Global Quality Operations maintains compliance in assigned responsibilities that include but are not limited to, non-batch record document reviews, temperature excursion assessments, authoring documents, use-by- date/retest-date extensions, deviations & complaints investigator and record archiving.
- REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
· BS or MS in a related scientific discipline.
· 3 – 5+ years’ experience within QA functions in pharmaceutical industry
· Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of drug process.
· Knowledge and application experience with batch record review, product disposition/release, change control, SOP review, contractor management, qualification and validation review, technology transfer, management notification processes
· Good computer skills and working knowledge of common business software
· Excellent organizational skills
· Excellent problem-solving, verbal and written communication skills
· Must have strong interpersonal and communication skills, be a team player
· Must be an individual with proven initiative and demonstrated accountability
· Professional integrity and maturity are required
- DUTIES AND RESPONSIBILITIES
Perform Batch Record Review Assignments: Assigns batch record review of batches of drug substance, drug product and package/labeling jobs to Specialist QA. Ensures that assignments are as equally distributed. Holds weekly batch status team meetings to ensure all assigned activities are on track and address/elevate any issues immediately to management. Tracks and reports batch record review metrics.
Perform Batch Record Review Function: Conducts batch record review of batches of drug substance, drug product and package/labeling jobs. Provides input on clinical product disposition. Establishes positive relationships and interfaces with contract manufacturers and testing laboratories to communicate and promptly resolve quality issues. May represent QA on assigned project and product teams. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Tracks and reports performance metrics as required.
Perform Document Review Function: (and may approve as required) SOPs, qualification and validation documents, technology transfer documents, analytical data and CMC sections prior to submission to regulatory bodies. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Tracks and reports performance metrics as required.
Compliance Systems: Implements and maintains the activities for batch record review, SOP review, contractor management, qualification/validation review, and technology transfer, in compliance with cGMPs, SOPs, good documentation practices and in accordance with corporate, regulatory and project timeline expectations.
Vendor Contacts: Communicates as required with outsourced manufacturing, packaging/labeling and/or testing service providers regarding quality assurance issues noted during reviews.
Communications: Proactively communicates, works with and provides timely services to staff and internal colleagues in QA, QC, AR&D, Investigational Materials Supply Chain (IMSC), Information Systems, Metrology, Facilities and Training groups.
Human Resources: Ability to function in a fast-paced environment and anticipate/adapt to changing needs and priorities. Consistently meets performance objectives. May be asked to assist in the evaluation of prospective employees for the quality assurance department.
- EDUCATION AND EXPERIENCE
Bachelors or Master’s Degree in a Scientific Discipline
- WORKING CONDITIONS: (US Only)
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.
- DEFINITIONS AND ABBREVIATIONS (As Applicable)
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.
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.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.