Quality Assurance (QA) Specialist

Danaher•Boulder, CO

2d•Onsite

About The Position

The Quality Assurance (QA) Specialist is responsible for providing 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, training, batch record review and release, and other process control functions. This position reports to the Manager of Quality Assurance and is part of the Quality Assurance team located in Boulder, CO and will be an on-site role. 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 organization in internal and external audits, as needed.

Requirements

Bachelor’s degree in life sciences (biology, chemistry, biochemistry, or related field)
1+ years of Quality Assurance experience in the manufacturing industry, especially in biotechnology and next-generation sequencing
Experience and familiarity working with ISO:9000/ISO:13485 standards and FDA QSR/cGMP standards.
Proficiency with computers and a variety of software, especially Microsoft Office Suites

Nice To Haves

SAP, MasterControl, and/or Maintenance Connection systems

Responsibilities

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 organization in internal and external audits, as needed.