Danaher Life Sciences
Sr Quality Assurance (QA) Specialist
Danaher Life Sciences, Boulder, Colorado, United States, 80301
Overview
Sr Quality Assurance (QA) Specialist
at
Danaher Life Sciences
IDT (Integrated DNA Technologies), a Danaher operating company. This on-site role is based in Boulder, CO and reports to the Sr Manager, Quality Systems within the Quality and Regulatory Affairs group. The Sr QA Specialist is responsible for providing administration, coordination, and maintenance of key components of the Quality Management System at the Boulder site, including document control, nonconformances, deviations, training, and other process-control functions. Responsibilities
Ensure timely completion and investigation of Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints). Review and release batch records, inspections, and COA creation for raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications. Interact professionally and efficiently cross-functionally with Manufacturing and support teams (Logistics, R&D, Product Management, Supply Chain Planning, QC). Implement, maintain, and improve IDTs Quality Management System in accordance with ISO 13485, 21 CFR 820, and regulatory guidance; collaborate with the IDT Global QS team. Participate in internal and external audits as needed. Essential Requirements
Bachelors degree in life sciences (biology, chemistry, biochemistry or related field). 3+ years of Quality Assurance experience in a manufacturing/biotech environment; next-generation sequencing experience preferred. 3+ years of experience in medical devices preferred. Experience with quality management systems and regulatory standards such as ISO 9000, ISO 13485, FDA QSR, or cGMP; ability to demonstrate familiarity with these frameworks in a regulated environment. Proficiency with computers and software (e.g., Microsoft Office Suite). Preferred/Additional
Strong verbal, written, analytical, and persuasive skills; ability to interact with all levels of employees and management. Ability to take responsibility for direction, control, or planning of a project. Experience with SAP, MasterControl, and Maintenance Connection. Compensation and Benefits
The annual salary range for this role is $85,000 - $100,000. This is the range Danaher believes in good faith at the time of posting and may be modified in the future. This role is eligible for bonus/incentive pay. We offer comprehensive benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. The amount and availability of any bonus, benefits, or other compensation remain at the Companys discretion, in accordance with the law. Equal Opportunity
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. Reasonable accommodations are available for applicants and employees with disabilities. If accommodation is needed for the application or interview process, or to perform essential job functions, please contact: 1-202-419-7762 or applyassistance@danaher.com. For more information, visit www.danaher.com. #J-18808-Ljbffr
Sr Quality Assurance (QA) Specialist
at
Danaher Life Sciences
IDT (Integrated DNA Technologies), a Danaher operating company. This on-site role is based in Boulder, CO and reports to the Sr Manager, Quality Systems within the Quality and Regulatory Affairs group. The Sr QA Specialist is responsible for providing administration, coordination, and maintenance of key components of the Quality Management System at the Boulder site, including document control, nonconformances, deviations, training, and other process-control functions. Responsibilities
Ensure timely completion and investigation of Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints). Review and release batch records, inspections, and COA creation for raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications. Interact professionally and efficiently cross-functionally with Manufacturing and support teams (Logistics, R&D, Product Management, Supply Chain Planning, QC). Implement, maintain, and improve IDTs Quality Management System in accordance with ISO 13485, 21 CFR 820, and regulatory guidance; collaborate with the IDT Global QS team. Participate in internal and external audits as needed. Essential Requirements
Bachelors degree in life sciences (biology, chemistry, biochemistry or related field). 3+ years of Quality Assurance experience in a manufacturing/biotech environment; next-generation sequencing experience preferred. 3+ years of experience in medical devices preferred. Experience with quality management systems and regulatory standards such as ISO 9000, ISO 13485, FDA QSR, or cGMP; ability to demonstrate familiarity with these frameworks in a regulated environment. Proficiency with computers and software (e.g., Microsoft Office Suite). Preferred/Additional
Strong verbal, written, analytical, and persuasive skills; ability to interact with all levels of employees and management. Ability to take responsibility for direction, control, or planning of a project. Experience with SAP, MasterControl, and Maintenance Connection. Compensation and Benefits
The annual salary range for this role is $85,000 - $100,000. This is the range Danaher believes in good faith at the time of posting and may be modified in the future. This role is eligible for bonus/incentive pay. We offer comprehensive benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. The amount and availability of any bonus, benefits, or other compensation remain at the Companys discretion, in accordance with the law. Equal Opportunity
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. Reasonable accommodations are available for applicants and employees with disabilities. If accommodation is needed for the application or interview process, or to perform essential job functions, please contact: 1-202-419-7762 or applyassistance@danaher.com. For more information, visit www.danaher.com. #J-18808-Ljbffr