Overview
Quality Assurance Coordinator (IDD Services) Jobs in Forked River, NJ at Community Options, Inc.
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
The Senior Manager, Analytical Development and Quality Control will manage outsourced analytical methods development and testing of drug substance and drug product. The position will also be responsible for authoring technical reports, deviations, change controls, and analytical sections of regulatory filings.
This is a hybrid role, typically on-site 3 days per week.
Responsibilities:
Manage the development, qualification, validation, and transfer of analytical methods at contract laboratories. Review analytical data from contract partners, provide feedback, and facilitate resolution of technical or quality issues
Manage release testing and stability testing of drug substance and drug product at contract laboratories
Oversee CMO analytical deviation & quality event investigations, and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results
Assist in the selection and management of contract laboratories
Collaborate with other members of the CMC team to ensure timely release of clinical products and resolution of product investigations
Author and review development reports, deviations, and change control documents
Author and review analytical sections of regulatory submissions
Preferred Skills, Qualifications and Technical Proficiencies:
Experience in analytical and regulatory requirements, including strong working knowledge of cGMPs, ICH, USP, and other relevant regulatory requirements
Good technical understanding of all aspects of analytical testing for small molecule pharmaceutical products. Experience in providing oversight for product release and stability testing at contract manufacturers and laboratories
Experience in facilitating resolution of product investigations promptly
Effective written and verbal communication skills. Experienced in drafting regulatory submissions
Able to manage multiple projects effectively. Enjoy working independently and collaboratively as part of a CMC team
Preferred Education and Experience:
Ph.D. in chemistry or relevant field with 3+ years of development experience in the pharmaceutical industry or M.S. in chemistry or relevant field with 5+ years of development experience in pharmaceutical industry
Excellent scientific knowledge of analytical chemistry and deep knowledge and experience of supporting pharmaceutical development and manufacturing of drug substance and various drug product dosage forms
Must have hands-on experience with analytical development techniques used in the pharmaceutical industry including LC, LC-MS, GC, and Dissolution
The pay range that the Company reasonably expects to pay for this headquarters-based position is $186,500 – $219,400; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
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Title: Quality Assurance Coordinator (IDD Services)
Company: Community Options, Inc.
Location: Forked River, NJ
