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Job Description
You have honed your knowledge, functional breadth and technical skills. This is your opportunity to join our dynamic team in Quality Engineering, providing guidance, expertise and services to ensure process and product quality. Here, you'll implement your vision by transforming broad concepts and business strategies into structured projects, lead the design and delivery of new programs and provide solutions to complex, high impact issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following:
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Represent Quality Assurance in assigned product development and analytical method development projects ensuring compliance to NASD Quality Management Systems (QMS) and external Quality Technical Agreements (QTAs) in general, with focus on Nonconformances (NCs), Change Control, Design Control, Risk Management, and Validation.
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Provide expertise, training, and/or consulting in Quality processes and methods to build and maintain a customer-oriented quality culture. Attending client meetings and communicate the client needs to the site.
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Establishes and maintains active dialogue with partners and clients with regard to product quality and Quality Assurance matters.
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Represent Agilent’s interests and requirements in the negotiation of roles and responsibilities between Agilent and client. Partners with internal and external stakeholders to gain approval of said roles and responsibilities in a Quality Technical Agreement (QTA) between Agilent and client.
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Lead and/or participate in client audits, coordinating the audit response teams, ensuring responses are delivered on time, and filing the audit documentation.
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Represent Design Assurance (design control/changes in Product Lifecycle) during regulatory inspections with Development representatives, as needed.
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Approve change controls, SOPs, Master Batch Records, Analytical protocols and reports, Batch Analytical Records, API Specifications, nonconformances, and CAPAs.
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Initiate and support NASD QMS improvements and assure maintenance and continuous improvement of NASD QMS procedures and systems within area of responsibility.
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Participate in product development, project reviews, and relevant project meetings.
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Support the QA role in product investigation meetings as required.
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Provide expertise, guidance and training within area of responsibility to the organization.
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Respond to customers and/or authorities’ requests/inquiries.
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Assist in PAI readiness activities and assists with preparation sessions for Agilent NASD staff.
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Support Quality Assurance oversight through writing, reviewing, and approving documentation, and other duties as assigned.
Qualifications
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Bachelor's degree (B.S.) in chemistry or related life-sciences field, with 8+ years of related experience/training, or an equivalent combination of education and experience.
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Prior experience in a GMP production environment is required.
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Strong technical writing and communication skills (written and verbal) focused on customer service and continuous process/program improvements.
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Knowledge of GMP guidelines and international regulations for API production and testing.
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Understanding of oligonucleotide or related pharmaceutical manufacturing processes.
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Proficiency in computer software and hardware applications, including Microsoft Office and the Internet.
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Time and priority management skills; ability to use discretion in completing work assignments and assist the group in setting priorities, standards, and meeting deadlines.
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Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations. Ability to write clear and concise reports, business correspondence, and procedures. Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding products and processes.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least February 17, 2025 or until the job is no longer posted.
The full-time equivalent pay range for this position is $119,200.00 - $186,250.00/yr 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: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory
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