Neurocrine Biosciences
About Neurocrine Biosciences
At Neurocrine Biosciences, we pride ourselves on a strong, inclusive, and positive culture based on our shared purpose and values. We are passionate about our people and our purpose – to relieve suffering for people with great needs. Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company’s portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington\'s disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, and a robust pipeline across core therapeutic areas. For three decades, we have applied our neuroscience insight to treat complex conditions, pursuing medicines to ease the burden of debilitating diseases. For more information, visit neurocrine.com and follow the company on LinkedIn, X and Facebook. About the Role
Provides quality assurance support for electronic document management system (EDMS), quality management system (QMS), and learning management system (LMS) under general supervision. Responsible for assisting in day-to-day operations of the electronic systems managed by the Quality Systems Department and ensuring compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements. Your Contributions (include, but are not limited to)
QA Systems Assists with user account management and basic security settings Helps respond to routine eSystem customer inquiries Assists in generating reports and dashboards for QADC and QMS analytics Supports data entry and file reconciliation activities Assists in system documentation maintenance Participates in routine quality assurance activities Supports inspection readiness activities QA General Writes SOPs for the creation, development or improvement of processes related to quality systems Prepares reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews Assists during compliance inspections and audit readiness as required Other duties as assigned Requirements
BS/BA degree in Chemistry, Biology, or related field and 2+ years of relevant experience OR Master’s degree in Chemistry, Biology, or related field and some similar experience as noted above Familiarity with regulatory documents is required Developing knowledge of FDA regulations and GxP guidelines Understands Neurocrine\'s business objectives and developing understanding of Neurocrine\'s services and customers Comfortable with tools and processes that support work conducted by the functional area Ability to work as part of a team Strong computer skills Good problem-solving and analytical thinking skills Detail oriented Ability to meet deadlines Strong verbal and written communication skills are required Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. The annual base salary we reasonably expect to pay is $75,300.00-$109,100.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
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At Neurocrine Biosciences, we pride ourselves on a strong, inclusive, and positive culture based on our shared purpose and values. We are passionate about our people and our purpose – to relieve suffering for people with great needs. Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company’s portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington\'s disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, and a robust pipeline across core therapeutic areas. For three decades, we have applied our neuroscience insight to treat complex conditions, pursuing medicines to ease the burden of debilitating diseases. For more information, visit neurocrine.com and follow the company on LinkedIn, X and Facebook. About the Role
Provides quality assurance support for electronic document management system (EDMS), quality management system (QMS), and learning management system (LMS) under general supervision. Responsible for assisting in day-to-day operations of the electronic systems managed by the Quality Systems Department and ensuring compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements. Your Contributions (include, but are not limited to)
QA Systems Assists with user account management and basic security settings Helps respond to routine eSystem customer inquiries Assists in generating reports and dashboards for QADC and QMS analytics Supports data entry and file reconciliation activities Assists in system documentation maintenance Participates in routine quality assurance activities Supports inspection readiness activities QA General Writes SOPs for the creation, development or improvement of processes related to quality systems Prepares reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews Assists during compliance inspections and audit readiness as required Other duties as assigned Requirements
BS/BA degree in Chemistry, Biology, or related field and 2+ years of relevant experience OR Master’s degree in Chemistry, Biology, or related field and some similar experience as noted above Familiarity with regulatory documents is required Developing knowledge of FDA regulations and GxP guidelines Understands Neurocrine\'s business objectives and developing understanding of Neurocrine\'s services and customers Comfortable with tools and processes that support work conducted by the functional area Ability to work as part of a team Strong computer skills Good problem-solving and analytical thinking skills Detail oriented Ability to meet deadlines Strong verbal and written communication skills are required Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. The annual base salary we reasonably expect to pay is $75,300.00-$109,100.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
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