Specialist, QA Systems - Training

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.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 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, classic congenital adrenal hyperplasia, 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

_

• Assist in maintaining training matrix and curricula in alignment with business structure;

• Collaborate with document owners and functional area heads to define requirements for controlled document and GXP training courses;

• Perform new hire orientation and training on the LMS, GXP, eSignature, etc.;

• Assist in validation activities for LMS change controls and releases;

• Assist with development of competency assessments for training events and controlled documents, as applicable;

• Manage periodic review of training curricula and training materials;

• Collaborate in the creation and review of applicable controlled documents;

• Administer and perform QA training events for EDMS and QMS user community;

• Responsible for GXP training metrics for monthly and quarterly reports;

• Coordinate and schedule GXP training events for NBI personnel;

• Participate in and assist with inspection readiness activities;

• Perform data-entry, and reconcile legacy and active training files;

• Assist in the creation, distribution, and maintenance of training courses in the LMS;

• Support the development, implementation, and maintenance of GXP training materials and program(s);

• Participate in or lead meetings and projects with cross-functional LMS Core team;

• Perform quality control review of documents and training materials; and

• Respond to customer training inbox inquiries.

• This position will be based in San Diego with expectations to be onsite designated days during the week. During training the expectation is to be more onsite prior to moving to the hybrid model.

• Additional duties as assigned.

• A minimum of 2 years of experience within the pharmaceutical/biotech industry managing training within an LMS (e.g., ComplianceWire, LearnShare, or similar), and records management activities OR

• Master's degree with some relevant work experience as noted above.

• Strong verbal and written communication skills are required

• Common Knowledge & Skills:
• Detail-oriented individual with excellent verbal and written communication skills,
• Ability to lift a minimum of 30 lbs.
• Think critically
• Able to Organize
• Provide ideas for process improvements,
• Ability to identify and escalate problems and follow-through with corrective actions.
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors.
• Ability to quickly learn new information and communicate requirements to the appropriate individuals.
• Must possess strong verbal and written communication skills along with sound organization skills.
• Demonstrates working knowledge of quality systems and regulatory compliance requirements within a commercial drug manufacturing operation is necessary.
• A good understanding of GXPs (GMP, GLP, GCP) principles is required.
• Works collaboratively in a team environment with the ability to solve problems and drive results.

#LI-SA1

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.

_