Associate Specialist, QA

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

The Computer System Validation specialist will play an integral role in ensuring that GxP computerized systems, whether on-premises or cloud-based, are validated or qualified in accordance with corporate quality standards.
This role is responsible for working with multiple stakeholders to ensure delivering of validation deliverables including management of the entire system life cycle. It is expected that the individual will work with cross functional stakeholders to achieve continuous improvement along with ensuring CSV requirements are met during the system maintenance phase.

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Your Contributions (include, but are not limited to):

• Computer System Validation Project Lead

  • Enforce validation deliverables based on Validation Plan strategies

  • Support validation deliverables not limited to specification, design, configuration, protocol, procedures, trace matrix and reports deliverables

  • Participate / support testing and resolution of deviations of computerized systems

  • Participate / support system periodic review

  • Train project team members regarding computer systems validation based on internal policy and procedures

• CSV Operations

  • Support continuous improvement projects / initiatives under broad supervision

  • Support cross functional groups to deploy systems

  • Maintain change management

  • Participate in various meetings to assist deployment

• QA General

  • Manage SOPs development to system deployment, not limited to admin, and/or operational procedures

  • Assist during compliance inspections and audit readiness as required

  • Other duties as assigned

Requirements:

• BS/BA degree in Chemistry, Biology, or related field AND some experience in quality systems and in conducting external audits, within the pharmaceutical or biotechnology industry. Experience with electronic documentation systems is desired. Relevant experience and knowledge for the small molecule or gene therapy pharmaceutical industry is desired.

• Familiarity with regulatory documents is required

• Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed

• Knowledge of software development life cycle

• High degree of focus and consistent attention to detail is required

• A good understanding of electronic record management and control

• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers

• Has experience in specific functional discipline while working to acquire higher-level knowledge and skills

• Comfortable with tools and processes that support work conducted by 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

• Good project management skills

• Strong verbal and written communication skills are required

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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.

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The hourly rate we reasonably expect to pay is $28.28-$39.97. 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 15% 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.