Integrated DNA Technologies
Sr Quality Assurance (QA) Specialist
Integrated DNA Technologies, Boulder, Colorado, United States, 80301
Sr Quality Assurance (QA) Specialist at Integrated DNA Technologies
Overview
The Sr Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining key components of the Quality Management System at the Boulder, CO site. This includes document control, nonconformances, deviations, training, and other process control functions. This is an on-site role reporting to the Sr Manager, Quality Systems within the Quality and Regulatory Affairs group in Boulder, Colorado. Responsibilities
Ensure timely completion and investigation of quality events (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, and QC). Implement, maintain, and improve IDTs Quality Management System in line with ISO 13485, 21 CFR 820, and regulatory guidance documents; collaborate with the IDT Global QS team. Participate in internal and external audits as needed. Qualifications
Bachelors degree in life sciences, preferably in biology, chemistry, biochemistry, or a related field. 3+ years of Quality Assurance experience in a manufacturing or biotechnology setting; 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; familiarity with these frameworks in a regulated environment. Proficiency with computers and Microsoft Office Suite (or equivalent). Preferred/Additional
Strong verbal and written communication, analytical, and persuasive skills; ability to interact with all levels of employees and management. Ability to take responsibility for project direction, control, or planning. Experience with SAP, MasterControl, or Maintenance Connection is a plus. Compensation and Benefits
The annual salary range for this role is $85,000 - $100,000. This role is eligible for bonuses/incentives and a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). Note: The amount and availability of any bonus, benefits, or other compensation remain at the Companys sole discretion, and may be modified at any time in accordance with applicable law. Company and Compliance
IDT, a Danaher operating company, is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other protected characteristics. Danaher and all colleagues are equal opportunity employers. Reasonable accommodations for applicants and employees with disabilities are available upon request at applyassistance@danaher.com. For more information, visit www.danaher.com. Note: This posting reflects the job description and responsibilities for the Sr Quality Assurance Specialist role at the Boulder, CO site and does not promise a specific employment period or guarantee. #J-18808-Ljbffr
The Sr Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining key components of the Quality Management System at the Boulder, CO site. This includes document control, nonconformances, deviations, training, and other process control functions. This is an on-site role reporting to the Sr Manager, Quality Systems within the Quality and Regulatory Affairs group in Boulder, Colorado. Responsibilities
Ensure timely completion and investigation of quality events (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, and QC). Implement, maintain, and improve IDTs Quality Management System in line with ISO 13485, 21 CFR 820, and regulatory guidance documents; collaborate with the IDT Global QS team. Participate in internal and external audits as needed. Qualifications
Bachelors degree in life sciences, preferably in biology, chemistry, biochemistry, or a related field. 3+ years of Quality Assurance experience in a manufacturing or biotechnology setting; 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; familiarity with these frameworks in a regulated environment. Proficiency with computers and Microsoft Office Suite (or equivalent). Preferred/Additional
Strong verbal and written communication, analytical, and persuasive skills; ability to interact with all levels of employees and management. Ability to take responsibility for project direction, control, or planning. Experience with SAP, MasterControl, or Maintenance Connection is a plus. Compensation and Benefits
The annual salary range for this role is $85,000 - $100,000. This role is eligible for bonuses/incentives and a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). Note: The amount and availability of any bonus, benefits, or other compensation remain at the Companys sole discretion, and may be modified at any time in accordance with applicable law. Company and Compliance
IDT, a Danaher operating company, is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other protected characteristics. Danaher and all colleagues are equal opportunity employers. Reasonable accommodations for applicants and employees with disabilities are available upon request at applyassistance@danaher.com. For more information, visit www.danaher.com. Note: This posting reflects the job description and responsibilities for the Sr Quality Assurance Specialist role at the Boulder, CO site and does not promise a specific employment period or guarantee. #J-18808-Ljbffr