Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Quality Control (QC) Specialist. The position reports to the Director, GMP Quality Assurance. The location of the position is in Brisbane, CA.
The Senior Quality Control Specialist is responsible for providing quality oversight of QC activities at contract service providers (CSPs). Primary responsibilities include analytical release and stability data review, deviation, change control and CAPA review. He/she will also provide Quality support for technical transfer/method validation activities for Active Pharmaceutical Ingredient (API) and Drug Product as needed, by closely working cross functionally with Analytical Chemistry, Formulation and Contract Manufacturing groups within Myovant and with personnel at CSPs. The individual must be able to work independently and function as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Essential Duties and Responsibilities
- Review and evaluate raw data generated for analytical release and stability testing at CSPs for compliance, adherence to method requirements and specifications.
- Review analytical methods and stability protocols/reports for API and Drug Product to ensure documents are compliant for use in clinical and commercial testing.
- Collaborate with Quality management to establish, improve and provide routine oversight of commercial QC programs including stability and reference standards.
- Support method validation and method transfer activities as needed.
- Working knowledge of compendial methods for small molecules and method verification requirements.
- Independently provide oversight of internal and external quality records including deviations, OOSs, change controls and CAPAs. Assure thorough and compliant investigations are performed with identification of appropriate corrective actions. Proactively collaborate with cross functional teams to ensure timely closure of quality records.
- Track Quality metrics for analytical activities at CSPs and proactively identify and implement improvement opportunities.
- Serve as a Quality representative, participating on cross-functional teams and perform other duties as assigned or required.
- Support Health Authority inspections and CSP audits, if requested.
Core Competencies, Knowledge, and Skill Requirements
- Small molecule analytical knowledge of techniques including HPLC, GC, and compendial methodologies.
- Understanding of Health Authority requirements for analytical method validation and transfer through all phases of development and commercialization.
- Demonstrated quality system expertise, with an emphasis on deviation, CAPA and change control systems.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, integrity, and trust building behavior.
- Must have excellent customer-service orientation, high degree of professionalism, ability to work with limited direction and work successfully within a cross-functional team/partnership environment.
- Demonstrates a positive, ‘can do’ and solution-oriented attitude.
- Ability to multi-task and shift priorities quickly while working under tight deadlines with limited direct supervision.
- Ability to learn and utilize computerized systems for daily performance of tasks.
- Strong PC experience and proficiency in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint a plus).
- Good organizational skills, attention to detail and solution focused.
- Ability to prioritize and handle multiple projects simultaneously.
- Bachelor’s degree in scientific discipline or related field.
- 6+ years of progressive experience working in a GMP environment within quality.
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements.
- Demonstrates a full working knowledge of compliance requirements.
- Interacts with other Myovant employees, and as required, with external representatives from across the supply chain for Myovant product.
- Excellent written, verbal communication skills, detail-oriented with a commitment to accuracy.
- Ability to build trust and respect within the organization.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity