What are the responsibilities and job description for the Sr. Specialist, QC position at Neurocrine Biosciences?
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.
What We Do: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:
Responsible for reviewing GMP analytical testing performed by contract sites and supporting internal GMP analytical laboratory operations._
Your Contributions (include, but are not limited to):Review and approve API and drug product analytical records for clinical and commercial products
Review and approve stability data supporting retest period assignment for clinical and commercial products. May perform analytical testing to support stability studies, as needed
Review and approve analytical test method validation protocols and reports. May perform analytical testing to support validation activities, as needed
Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab
Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate
Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues
Participate in deviation and laboratory investigation teams
Review and compile data for regulatory submissions
Conduct and support audits of external vendors
Assist during onsite inspections and inspection readiness activities
Perform additional duties as assigned by management
B.S. Degree in Chemistry, Biology, or related field and 4 years of experience within the pharmaceutical or biotechnology industry OR
Master's and 2 years of related experience
Experience applying CGMP requirements in a Quality Control setting
Working knowledge of quality systems and regulatory compliance requirements within a clinical and commercial drug manufacturing operation
Experience in analytical development and/or testing in a Quality Control setting
Experience with using electronic documents management systems, laboratory data management systems, document control and records management
Knowledge of US FDA and European regulations and ICH Guidelines
Works well in a team environment
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Capable of handling multiple responsibilities and prioritizing appropriately
Attention to detail, critical thinker and effective organizational skills
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
Apply problem-solving tools for root cause analysis
Excellent computer skills
Strong communication skills
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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.
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The annual base salary we reasonably expect to pay is $95,100.00-$138,050.00. 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.Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
Salary : $95,100 - $138,050
