QC Investigator

Job Description

The worlds most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing lifesaving medicines.

The Quality Control Laboratory Investigator position performs investigations for events that occur in the Quality Control laboratories including but not limited to deviations sample acceptance criteria not being met analytical testing results that are potentially Out of Specification (OOS) or Out of Trend (OOT) discrepancies unexpected results etc. to improve the quality control testing processes by implementing corrective and preventative actions. Other duties may include writing or revising SOPs change controls and other technical documentation generated by Quality Control. This position description (POD) covers all levels of the Quality Control Investigator (entry intermediate advanced expert and master).

ESSENTIAL DUTIES AND 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.

KNOWLEDGE SKILLS AND ABILITIES:

• 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.
• Computer skills especially with Microsoft Word Excel Visio are preferred. Skill in managing various projects; must be able to use individual discretion in completing work assignments while assisting the group in establishing priorities setting standards and working collectively to accomplish deadlines and objectives.
• 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.

Qualifications

• Bachelors degree in chemistry biology engineering or related life science field; or an equivalent combination of education and related experience.
• 2 years relevant experience required
• Prior experience in a GMP Laboratory supporting Manufacturing in-process and release testing preferred
• Requires in-depth knowledge and experience in job and ability to work independently

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least January 20 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $93760.00 - $146500.00/yr plus eligibility for bonus stock and benefits. Our pay ranges are determined by role level and location. Within the range individual pay is determined by work location and additional factors including job-related skills experience and relevant education or training. During the hiring process a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals regardless of personal characteristics are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex pregnancy race religion or religious creed color gender gender identity gender expression national origin ancestry physical or mental disability medical condition genetic information marital status registered domestic partner status age sexual orientation military or veteran status protected veteran status or any other basis protected by federal state local law ordinance or regulation and will not be discriminated against on these bases. Agilent Technologies Inc. is committed to creating and maintaining an inclusive in the workplace where everyone is welcome and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility please email or contact 1-. For more information about equal employment opportunity protections please visit Required: Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory