About the Role:
Supports the execution and maintenance of quality systems and compliance processes within a GxP-regulated environment. Performs moderately complex activities with general supervision, applying established procedures and sound judgment to ensure quality systems and related processes (e.g., deviations, change control, vendor management, product complaints, document control) remain compliant with internal standards and regulatory requirements. Contributes to the effectiveness of the Quality Management System (QMS) by supporting process improvements, maintaining data integrity, and collaborating with cross-functional partners. Applies developing subject matter knowledge of GxP regulations and quality systems to resolve routine to moderately complex issues and escalate as appropriate. Your Contributions (include, but are not limited to):Perform day-to-day moderately complex activities for quality systems and processes, including document control, LMS administration, vendor-related processes, investigations, product complaints, change control, CAPA, SCAR, and deviations Execute administrative and operational tasks, including data entry, document processing, record maintenance, and reconciliation of QA records to ensure accuracy, completeness, and traceability Support the maintenance and use of electronic quality systems, including user support, system documentation, and routine system-related activities Review and process controlled documents to ensure proper formatting, completeness, and compliance with company standards and procedures Edit, maintain, and process revisions of SOPs, work instructions, and other controlled documents to ensure accuracy and consistency Support inspection and audit readiness activities, including coordination and execution of back room and inspection room support Generate and maintain routine reports, metrics, trackers, and dashboards to support QA performance monitoring and data integrity Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies Identify and communicate quality or compliance issues within defined processes; escalate and support follow-up actions and resolution Support continuous improvement initiatives by identifying opportunities and assisting with implementation within defined scope Maintain working knowledge of applicable GxP regulations, internal procedures, and industry standards Perform other QA-related duties, as assigned
Requirements:- 6+ years of applicable experience/training ORBS/BA degree in Chemistry, Biology, or related field AND 2+ years of relevant experience ORMaster's degree in Chemistry, Biology, or related field AND some similar experience as noted above
- Strong written and verbal communication skills, with the ability to effectively collaborate with cross-functional stakeholders
- Solid organizational, planning, and prioritization skills, with the ability to manage multiple tasks in a dynamic environment
- Strong attention to detail with a focus on accuracy, data integrity, and compliance
- Demonstrated problem-solving and analytical skills, with the ability to exercise judgment within defined procedures
- Ability to work effectively both independently and as part of a team
- Proficiency with standard computer applications and systems
- Ability to apply company policies and procedures to resolve routine to moderately complex issues
- Working knowledge of quality systems and compliance processes within a GxP-regulated environment (e.g., deviations, CAPA, change control, document control, training, supplier quality, product complaints)
- Understanding of applicable regulatory requirements and industry standards (e.g., FDA, ICH, GxP, GMP, GLP, GCP)
- Experience supporting electronic quality systems (e.g., QMS, LMS) including data entry, record maintenance, and basic system support
- Knowledge of documentation practices and requirements to ensure accuracy, completeness, and traceability of QA records
- Familiarity with audit and inspection support activities, including document retrieval and tracking
- Ability to generate and interpret standard QA reports, metrics, and dashboards to support monitoring and review
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 $76,800.00-$105,000.00. 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.
