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Job Title: GMP Quality Specialist
Company Name: Aldevron
Location: Fargo, ND United States
Position Type: Full Time
Post Date: 09/29/2022
Expire Date: 10/29/2022
Job Categories: Biotechnology and Pharmaceutical, Engineering, Healthcare, Other, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Quality Control, Medical
Job Description
GMP Quality Specialist

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.

Job Summary:

The Quality Engineer interfaces with members of Quality Assurance (QA), Quality Control (QC), Operations, and Facilities teams to review manufacturing and Quality Control documentation, disposition materials, and provide real-time operational oversight. This role performs timely reviews of all batch documentation; assure that batch records are complete, correct, accurate, and satisfy all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP) expectations.

Responsibilities:

  • Cross functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modelling (linear regression, T-test, control charts, etc.), and develop/maintain client specific process datasets.

  • Perform GMP oversight, and real time review of manufacturing documentation including batch records and protocols during execution.

  • Release manufacturing rooms following required reviews and after confirming acceptance criteria have been met.

  • Assist in developing process capability metrics and other statistical tools to evaluate ongoing process performance.

  • Able to assess and review SOPs and forms to determine compliance to a standard.

  • Responsible for timely completion of review and/or investigation into Corrective Action Preventive Actions and other Quality Investigations.

  • Perform timely and thorough review of all batch documentation to assure that all documentation is complete, accurate, and that it conforms to all regulatory and statutory requirements for release.

Qualifications:

  • Bachelor of Science, life science related, preferred. Equivalent experience may be considered

  • A minimum of three (3) to five (5) years of experience in a Quality or auditing role. If experience is in an equivalent GMP facility, such as biotech, pharma, medical device manufacturing, etc., 2 years may be considered

  • Experience working in a regulated or GMP compliant environment

When you join us, youll also be joining Danahers global organization, where 69,000 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 powerfulDanaher Business Systemtools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID19 as a condition of employment, subject to reasonable accommodation as required by law.

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 availablehere.

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 atapplyassistance@danaher.comto request accommodation.

If youve ever wondered whats within you, theres no better time to find out.

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.

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 youve ever wondered whats within you, theres no better time to find out.

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Contact Information
Contact Name:
Company Name: Aldevron
Phone Number:
Contact Email:
Website:https://jobs.danaher.com/global/en/job/DANAGLOBALR1207768EXTERNALENGLOBAL/GMP-Quality-Specialist?utm_source=hbcuconnect&utm_medium=phenom-feeds
Company Description:

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