Quality Specialist I|
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 worlds 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, were pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Quality Assurance Specialist I is responsible for supporting the quality system processes including Document Control, Records Review, Label Reviews and Records Management as well as Receipt Inspection. This position will also support SOP & Forms creation, revision and archival.
Reviewing/approving and generating reports on documents, as needed
Maintaining, storing and coordinating archiving of documents
Conduct Receipt Inspection activities for critical incoming materials
Support quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products.
Maintain quarantine locations and quarantined material and follow up on disposition of quarantined materials
Provide support during audits performed of Aldevrons Madison by internal and 3rd party auditors, clients and regulatory agencies.
Support Aldevrons audit program to ensure processes are performed in accordance with written procedures
Maintain quality assurance standards, processes and controls.
As needed, assist with creation and modification of QualitySystem procedures and related documentation.
Assist with processing activities related to the Deviations (Quality Events), Complaints, Changes and CAPA program(s)
Support the Quality Systems Manager by ensuring effective implementation and maintenance of quality systems
Participate in and support quality improvement initiatives
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.
When you join us, youll also be joining Danahers global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, youll 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.
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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 email@example.com to request accommodation.
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