Agilent Technologies · 11 hours ago
QC Investigator
Boulder, CO
Full-time
Onsite
Entry, Mid Level
$94K/yr - $146K/yr
2+ years expAgilent Technologies is a leading company in the biopharma sector, focusing on the development and commercialization of nucleic acid therapeutics. The Quality Control Laboratory Investigator position involves conducting investigations in the Quality Control laboratories to enhance testing processes and ensure product quality through corrective actions.
BiotechnologyHealth CareHealth DiagnosticsLife SciencePharmaceutical
Responsibilities
Lead investigation activities by gathering information from all necessary internal and external sources using investigation tools to: Perform the Root Cause Analysis (RCA) to determine if the deviation is a result of a laboratory error
Evaluate the impact of the deviation on the product
Determine the risk to previous products or future operations
Determine what additional testing must be performed to identify root cause or to generate acceptable results and formulate testing plan
Collaborate with cross-functional teams to develop effective Corrective and Preventive Action (CAPA) plans to prevent recurrence
Author comprehensive investigation reports. Review quality and regulatory documentation and conduct interviews with internal sources to obtain an in-depth understanding of the product and process
Analyze QC laboratory data and evaluate trends to identify continuous process improvement opportunities
Consults with the Quality Assurance and Quality Control groups to resolve quality, QC Laboratory, and efficiency issues
Manage multiple deviations, CAPAs, and Change Controls as necessary to closure within established timelines and batch disposition dates
Write and/or revises technical documentation including SOPs and other documents as required. Participate with internal and external regulatory audits and inspections as required
Maintain safe, secure, and healthy manufacturing environment by adhering to organizational standards and policies and to legal regulations, alerting others regarding potential concerns
Qualification
Required
Bachelor's degree in chemistry, biology, engineering or related life science field; or an equivalent combination of education and related experience
2+ years relevant experience required
Knowledge of Good Manufacturing Practice (GMP) guidelines as well as international regulations (i.e., International Conference on Harmonization (ICH) Q7) pertaining to the production of Active Pharmaceutical Ingredients (API) and drug products
Have the training and ability to participate in and/or lead investigations applying scientific methods and effectively present findings and solutions to customers, co-workers, or members of management
Able to identify personnel and documentation to support knowledge of equipment and processes utilized to analyze materials used in production of APIs such as, but not limited to: raw materials, in-process samples, and API/DP
Skill in communication, written and verbal
Ability to lead cross-functional teams
Ability to interface with clients as required
Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the internet, are required
Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations
Ability to write reports, business correspondence, and procedures
Ability to respond to common inquiries, comments or complaints from customers, co-workers, subordinates, and supervisors regarding the documents, products and processes
Actively lead or participate in the investigation of major QC laboratory investigations including providing technical assistance to Quality Assurance (QA) on the final product impact assessment and identification of root cause
Outstanding communication skills, understanding of cGMP regulations and knowledge of investigation techniques including root cause analysis (RCA) and technical writing skills are required
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Preferred
Prior experience in a GMP Laboratory supporting Manufacturing in-process and release testing
Benefits
Eligibility for bonus
Stock
Benefits
Company
Agilent Technologies
Agilent Technologies addresses the scientific and laboratory management needs of analytical scientists and clinical researchers.
10001+ employees
H1B Sponsorship
Agilent Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (51)
2024 (56)
2023 (58)
2022 (70)
2021 (64)
2020 (53)
Funding
Current Stage
Public CompanyTotal Funding
$500M2019-09-05Post Ipo Debt· $500M
1999-11-26IPO
Leadership Team
Mike McMullen
CEO and President
Padraig McDonnell
President and CEO
Recent News
Research & Development World
2026-01-09
News-Medical.Net
2025-12-24
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