QC Investigator

Agilent Technologies•Frederick, MD

14h

About The Position

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).

Requirements

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.
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.
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

Nice To Haves

Computer skills, especially with Microsoft Word, Excel, Visio are preferred.
Prior experience in a GMP Laboratory supporting Manufacturing in-process and release testing preferred

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.