Deviation Investigator Associate

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

Responsible for on time completion and writing of deviations, laboratory investigations, and/or assigned corrective/preventative actions. Can lead manufacturing or laboratory investigations with minimal guidance. Works directly with supervisors, operators, or other Corden staff to collect data to support root cause analysis and CAPA identification. Participates in Operational Excellence Program.

Include the following. Other duties may be assigned.

• Responsible for initiation, completion, drafting, and on time closure of investigations assigned
• Work closely with cross functional teams to collect data and conduct interviews immediately following a deviation; including working with technical teams to identify and document deviation impact
• Lead and perform root cause analysis to determine most likely root cause/ contributing factors for a deviation
• Gather and interpret data to ensure the deviation includes a documented justification for impact on materials, product, or system within scope of the deviation
• Facilitation and/or participation in meetings to drive internal alignment between the review team/area subject matter expert(s) on an investigational path forward
• Identification and communication of observed trends to drive effective and sustainable system process improvements
• Able to progress multiple projects and deviations simultaneously
• Collaborate internally and with customers for correction resolution on deviation drafts
• Participation in the Corden Operational Excellence Program to drive continuous improvement
• Collaborate and/or update procedures/documentation to address identified CAPAs
• Perform investigation in compliance with applicable Corden Pharma procedures

Provides guidance and leadership where appropriate, based upon the results of deviations. Leads efforts for investigations assigned and process improvements identified.

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy.

CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.

cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s Degree (BS) from a college or university in a technical field (Engineering,…