QC Method Validation Expert

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QC Method Validation Expert

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

Responsibilities:

• Authors, reviews and approves and/or executes protocols, and/or authors reports, for the validation, qualification, or verification of testing methodologies used to control raw materials, production intermediates, and final products, performed in accordance with Agilent data integrity policies.
• Authors, reviews and approves method qualification/validation/verification reports per Agilent's policies.
• Works to troubleshoot, repair, and provide preventative maintenance for analytical instrumentation.
• May participate in installation activities for new or existing instrumentation and/or support instrument qualifications as needed
• Acts as the subject matter expert (SME) and represents the QC department in aspects related to method qualification, validation and verification.
• Coordinates method qualification, validation and verification efforts and schedules between Analytical Services and QC departments to ensure timely execution and completion.
• Participates in identifying key performance indicators (KPI) relevant to method validation efforts and generated useful metrics to measure the health method validation and method transfer efforts.
• Provides technical consultation to Quality Control analysts, supports method optimization efforts and participates in troubleshooting related to validated method parameters.
• May conduct routine and non-routine analysis of raw materials, in-process and finished formulations as well as data reviews according to standard operating procedures. May support stability testing as needed.
• Supports other tasks within the QC group as assigned by QC management.

Qualifications

• Bachelor’s degree with a minimum of 8-years’ experience, or a master’s degree with a minimum of 5 years’ experience or a doctorate degree with 2 years’ experience.
• Requires specialized depth and/or breadth of expertise in development, qualification and verification of analytical methods.
• Knowledge of FDA regulations and guidelines with extensive knowledge of cGMP guidelines including but not limited to FDA, ICH, EU, is a must.
• Experience developing and qualifying analytical methods is required pertaining to Quality Control programs that support production of APIs, stability and drug product release.
• Demonstrated knowledge of analytical equipment and instrumentation is required.
• Experience with specialized analytical equipment such as Q-TOF & Single Quad. LCMS, ICP-MS, and NMR is required.
• Proven track record in coordinating and leading day to day tasks and working in collaboration to accomplish tasks and meet deadlines.
• Personnel leadership skills and ability to work in a team environment is required.
• Works across functional lines to complete projects in a timely fashion.
• Strong written and verbal communication skills.
• Knowledge of and skills using computer software and hardware applications, including Microsoft Word and Excel.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least February 7, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $49.62 - $77.52/hr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at:https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

• Travel Required: 10% of the Time
• Shift: Day
• Duration: No End Date
• Job Function: Quality/Regulatory