Neurocrine Biosciences
Overview
Specialist, QA Systems
role at
Neurocrine Biosciences . 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. Responsibilities
Provide QA support for EDMS, QMS, and LMS under general supervision. Assist with user account management and basic security settings. Help respond to routine eSystem customer inquiries. Assist in generating reports and dashboards for QADC and QMS analytics. Support data entry and file reconciliation activities. Assist in system documentation maintenance. Participate in routine quality assurance activities. Support inspection readiness activities. Write SOPs for the creation, development or improvement of processes related to quality systems. Prepare reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews. Assist during compliance inspections and audit readiness as required. Other duties as assigned. Qualifications
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. Understanding of 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. Compensation and Benefits
The annual base salary range is
$75,300.00-$109,100.00 . Individual pay decisions depend on factors such as primary work location, role complexity and responsibility, duties/requirements, and relevant experience and skills. This position offers an annual bonus with a target of 20% of base salary and eligibility to participate in the equity-based long-term incentive program. Benefits include retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental and vision) according to plan terms. About Neurocrine Biosciences
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 encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. Location: San Diego, CA.
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Specialist, QA Systems
role at
Neurocrine Biosciences . 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. Responsibilities
Provide QA support for EDMS, QMS, and LMS under general supervision. Assist with user account management and basic security settings. Help respond to routine eSystem customer inquiries. Assist in generating reports and dashboards for QADC and QMS analytics. Support data entry and file reconciliation activities. Assist in system documentation maintenance. Participate in routine quality assurance activities. Support inspection readiness activities. Write SOPs for the creation, development or improvement of processes related to quality systems. Prepare reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews. Assist during compliance inspections and audit readiness as required. Other duties as assigned. Qualifications
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. Understanding of 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. Compensation and Benefits
The annual base salary range is
$75,300.00-$109,100.00 . Individual pay decisions depend on factors such as primary work location, role complexity and responsibility, duties/requirements, and relevant experience and skills. This position offers an annual bonus with a target of 20% of base salary and eligibility to participate in the equity-based long-term incentive program. Benefits include retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental and vision) according to plan terms. About Neurocrine Biosciences
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 encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. Location: San Diego, CA.
#J-18808-Ljbffr