Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy.  We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all.   We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.  

Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Job Summary:

The Quality Assurance Specialist II is responsible for supporting the quality system processes including Internal Audits, Corrective Actions Preventive Actions (CAPA), Document Control, and Supplier Quality audits.

Responsibilities:

• Responsible for maintaining quality assurance standards, processes, and controls while developing and implements methods for inspection, testing, sampling, and training


• Support quality assurance programs, processes, and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products


• Assist with implementation and training of all employees regarding the quality system and overall compliance with the corporate quality manual


• Identifies compliance risks at Aldevron through auditing process'


• Support of the CAPA system by ensuring all events are adequately investigated, appropriate CAPA actions are put into place and records are closed within a timely manner


• Support of Aldevron's internal audit program to ensure processes are performed in accordance with written procedures and other applicable external requirements 


• Support of Aldevron's validation process by reviewing protocols, testing plans and final reports, as assigned

Qualifications:

• B.S. degree in a science or related field


• 3 years of Quality Assurance or Regulatory Compliance experience in a GMP environment


• Knowledge of FDA's GMP and GLP guidelines


• Knowledge of ISO certification and requirements

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.  Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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