QC Investigator

Job Description


The world's 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…