Quality Assurance (QA) Specialist
Job Location:
Boulder, CO - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
AtIntegrated DNA Technologies (IDT)one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
Our team at Integrated DNA Technologies (IDT) is united by a commitment to collaboration and scientific excellence building on a strong foundation of innovation expertise and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer infectious disease rare genetic disorders and more. At IDT youll be part of a culture rooted in continuous learning and improvementwhere your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier brighter future for all.
Learn about theDanaher Business Systemwhich makes everything possible.
TheQuality Assurance (QA) Specialistis responsibleforproviding administration coordination and maintaining the key components of the Quality Management System (QMS) at the Boulder CO site. This may include but is not limited to document control nonconformances deviations trainingbatch record review and release and other process controlfunctions.
This positionreports to theManager of Quality Assuranceandis part of theQuality Assuranceteamlocated inBoulder COand willbeanon-siterole.
In this role you will have the opportunity to:
- Perform timely review and release of batch records Device History Records (DHRs) and inspection results for raw materials in-process materials subassemblies and finished goods to ensure compliance with product specifications quality requirements and procedures.
- Maintain and support document control and training processes within the eQMS including document control review and approvals employee training assignments and physical record retention.
- Initiate investigate and support closure of quality events including Nonconformances Deviations CAPAs and Issue Reviews utilizing risk-based and root cause analysis methodologies.
- Collaborate effectively with Manufacturing Logistics Quality Control Supply Chain Planning and other cross-functional teams to ensure compliance with quality system requirements and support continuous improvement initiatives.
- Participate and represent the Quality organizationininternal and external auditsas needed.
Theessential requirements of the job include:
Bachelors degree inlife sciences (biology chemistry biochemistryetcor related field)
1 years ofQuality Assurance experience in the manufacturing industry especially in biotechnology and next-generation sequencing
Experience and familiarityworkingwith ISO:9000/ISO:13485 standards and FDA QSR/cGMP standards.
Proficiencywith computers and a variety ofsoftwareespecially MicrosoftOffice Suites
It would be a plus if you also possess previous experience in:
SAP MasterControl and/or Maintenance Connection systems
The annual salary range for this role is between $63000.00 - 80000.00 USD Annual. This is the range that we in good faith believe isthe range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off medical/dental/vision insurance and RetirementBenefits to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested anddeterminable. The amount and availability of any bonus commission benefits or any other form of compensation andbenefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid andmay be modified at the Companys sole discretion consistent with the law.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
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.
The U.S. EEO posters are available here.
For candidates who are based outside of New York City or who are applying for roles outside of New York City for more information about conditions of any job offer please click here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
IC
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
