The Quality Assurance Specialist is responsible for supporting GMP activities occurring at Contract Manufacturing Organizations. This position will work closely with Quality Assurance and Supply Chain representatives to support disposition activities for GMP materials. The Quality Assurance Specialist will also provide quality support for related functions, including Drug Substance and Drug Product manufacturing and quality system support. The successful candidate is self-motivated, independent, highly organized and able to work in a small team environment. The Quality Assurance Specialist must multitask and adjust direction based on changing project/corporate priorities.
Provide QA support for the review and disposition of starting materials, bulk drug substance and drug product for small molecule, Oral Solid Dosage (OSD) manufacturing activities
Support release and disposition for Finished Goods for global trials
Review various documents such as batch records, technical reports, data, stability protocols and other GxP documents as needed
Write and review Standard Operating Procedures (SOPs) and Forms
Aid in the implementation of Electronic Document Management and Training System
Maintain logs for Quality systems, such as CAPA, Deviations, Investigations and Release Records
Support development and execution of document archival system(s)
Support the identification and investigation of quality related complaints or deviations, identifying and resolving root causes
SKILLS & REQUIREMENTS:
Bachelor's Degree in related field and minimum 4 years' experience in Pharmaceutical Industry in a related quality assurance role, or the equivalent combination of education, training and experience.
Experience with reviewing and dispositioning GxP materials
Ability to identify technical problems and suggest resolution of the issues
Excellent organizational, interpersonal and decision-making skills, as well as verbal and written communication skills
Knowledge of FDA and international regulations and GxP guidelines
Comfortable in a fast-paced environment and able to navigate changing priorities
Corbus is a close-knit team of almost 100 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our "family" atmosphere where each person's contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer
Corbus Pharmaceuticals Holdings, Inc.