Senior Specialist, Quality Operations
2 weeks ago
Senior Specialist, Quality OperationsCorcept 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 Specialist, Quality Operations is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution.Responsibilities:Support various Chemistry, Manufacturing and Controls (CMC) projectsWork cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizationsInterface with CMOs/CTLs to provide QA oversight of routine manufacturing and packaging activitiesPerform product disposition/batch releaseReview and approve master batch records and executed batch recordsReview and approve quality control records (e.g., COAs, specifications, analytical protocols and reports, stability protocol and reports, etc.)Review and approve manufacturing records (e.g., validation/development/transfer protocols and reports etc.)Review and approve quality events (e.g., deviations, change controls, CAPAs and complaints)Ensure timely complaint initiation, investigation/analysis and closureSupport quality audit of suppliers, CTLs and CMOsOther duties as assignedPreferred Skills, Qualifications and Technical Proficiencies:Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processesAbility to work independently and communicate effectively with project team members, management groups and suppliersWorks well in a project team environment with solid problem analysis and decision-making abilityAbility to author, review and approve SOPs and other controlled documentation for compliance with applicable regulationsAdvanced Microsoft Office application skills (Word, Excel, PowerPoint)Travel requiredPreferred Education and Experience:BA/BS or master's degree in science, engineering or related field6+ years in Quality AssuranceKnowledge in the application of 21CFR211, global cGMP regulations and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery and control of pharmaceutical productsThe pay range that the Company reasonably expects to pay for this headquarters-based position is $127,400 - $149,000; 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.
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Senior Specialist, Quality Operations
3 days ago
Redwood City, California, United States Corcept Therapeutics Full time $127,400 - $149,000 per yearCorcept 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...
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Redwood City, California, United States Corcept Therapeutics Full time $127,400 - $149,900 per yearCorcept 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...
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Senior Quality Specialist
4 days ago
Oklahoma City, United States Oklahoma Staffing Full timeCvs Health Quality SpecialistAt CVS Health, we are building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000...
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Senior Quality Specialist
6 days ago
Carson City, United States Nevada Staffing Full timeJob Opportunity At CVS HealthAt CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000...
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Redwood City, California, United States Soleno Therapeutics, Inc. Full time $80,000 - $120,000Summary of Job (brief description)Soleno Therapeutics, Inc., based in Redwood City, California, is a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. We are seeking a highly motivated individual to join Soleno Therapeutics who will play a key role within Quality Assurance foroperational support. Responsibilities...
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Senior Specialist, Supply Chain
4 weeks ago
Redwood City, United States Revolution Medicines Full timeSenior Specialist, Supply ChainRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring...
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Senior Quality Specialist
2 weeks ago
Salt Lake City, United States Utah Staffing Full timeJob Opportunity At CVS HealthAt CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000...
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Senior Manager, GMP Quality
1 week ago
Redwood City, United States Revolution Medicines Full timeSenior Manager, GMP QualityRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring...
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Senior Quality Specialist
4 days ago
Kansas City, Missouri, United States JE Dunn Construction Full time $100,000 - $120,000 per yearLocation:Kansas City, MO, US, 64106Best People + Right Culture. These are the driving forces behind JE Dunn's success.By hiring inspired people, giving them interesting and challenging work, enabling them with innovative tools, and letting them share in the company's rewards, we've found a sustainable way to grow in our industry for the last 100+ years.Our...
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Senior Payroll Specialist
2 weeks ago
Redwood City, United States Planet Pharma Full timeThis range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $35.00/hr - $55.00/hr Seeking a motivated individual to play a critical role in the payroll team. Reporting directly to the Associate Director, Payroll, this position requires a meticulous individual...
