Celgene QA Specialist, Operations Development in Summit, 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.
QA Specialist, Operations Development QASummit, NJ
Associate Director Operations, Development QA
Prerequisites (As Applicable)
Associates/Bachelor’s degree in a scientific discipline
PURPOSE AND SCOPE OF POSITION:
The Dev QA Associate Specialist is primarily responsible for the review of development batch records to ensure that the records meet cGMPs and submission requirements. The Dev QA Specialist also has additional responsibilities to ensure that Global Quality Operations – Development 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
AS or BS in a related scientific discipline.
2+ years experience within QA functions in pharmaceutical industry
Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of drug development 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
Strong organizational skills
Strong 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 Development Batch Record Review Function: Conducts batch record review of development 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 development product teams. Notifies 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 and forms. Notifies 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 development batch record review, SOP review, contractor management, qualification and validation review, 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.
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.