Quality Assurance Specialist

7 days ago

Boulder, Colorado, United States Danaher Corporation Full time
Job Title: Sr. Quality Assurance Specialist

Integrated DNA Technologies (IDT) is a leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions.

We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher, accelerating the discovery, development, and delivery of solutions that safeguard and improve human health.

This position is part of the Quality Assurance Team located in Boulder, Colorado, and will be on-site. At IDT, we celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.

Key Responsibilities:
  • Maintains records and processes for document handling, audit, process controls (NCR/Deviation/CAPA), and training.
  • Interacts professionally and efficiently with manufacturing and support staff, administering/supporting the intra-department functionality of the QMS with departments throughout IDT.
  • Prepares reports of quality system performance for internal departmental use and management review.
  • Assists in developing content for and delivering training on various quality systems functions, such as NCRs, deviations, document control, training system administration, and validation activities.
  • Participates in customer and third-party audits, serves as a member of internal audit teams, and assists with the development and implementation of responses for customer, regulatory, and certifying body audits.
Requirements:
  • Bachelor's degree in life sciences (biology, chemistry, biochemistry, etc.) or related field or Advanced degree (Master's or PhD) in life science.
  • 3+ years of experience in a manufacturing environment, especially life science or biotechnology industries.
  • 3+ years of experience in a manufacturing operations, quality control, or quality assurance role.
  • Demonstrated technical ability and accuracy to perform mathematical calculations and unit conversions.
  • Demonstrated ability to adhere to strictly defined protocols and procedures.
Preferred Qualifications:
  • Familiarity with SAP, MasterControl, and Maintenance Connection.
  • Experience working in a regulated laboratory environment in the biotech industry or academic environment.
  • Quality Assurance experience in the manufacturing industry, especially biotechnology and next-generation sequencing (NGS).
  • Experience working in a regulated environment, especially ISO 9001, ISO 13485.

The salary range for this role is $72,000 - $90,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. 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 401(k), to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

At Danaher, we bring together science, technology, and operational capabilities to accelerate the real-life impact of tomorrow's 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology, and beyond. For more information, visit www.danaher.com.

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 (https://www.dol.gov/agencies/ofccp/posters).

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.

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