Deviation Investigator & CAPA Lead

Corden Pharma - A Full-Service CDMO; Boulder (CO); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Dental Insurance

Vision Insurance

Paid Vacation

Job summary

Corden Pharma Colorado (CPC) is seeking a Detail-oriented Investigator to manage deviations, write investigations, and support CAPA closure. You will collect data, lead root cause analyses, and coordinate with cross-functional teams to ensure timely, compliant investigations under cGMP guidelines.

You will participate in the Operational Excellence Program, update procedures, and help drive continuous improvement while maintaining high quality and patient safety standards in a fast-paced

Qualifications

• Bachelor’s Degree (BS) in a technical field and 2 years Pharmaceutical Manufacturing experience.
• Ability to read, analyze, and interpret procedures, technical data, and regulations; able to write reports and procedures.

Responsibilities

• Initiation, completion, drafting, and on time closure of investigations assigned
• Work with cross functional teams to collect data and conduct interviews after a deviation; document impact
• Lead root cause analysis to determine most likely causes and contributing factors
• Gather and interpret data to ensure deviations have documented justification for impact
• Facilitation or participation in meetings to align review team and subject matter experts on investigational path
• Identify and communicate observed trends to drive sustainable process improvements
• Progress multiple projects and deviations simultaneously
• Collaborate with customers for correction resolution on deviation drafts
• Participate in the Operational Excellence Program to drive continuous improvement
• Update procedures and documentation to address CAPAs
• Perform investigations in compliance with applicable procedures

Skills

Technical writing

Teamwork

Problem solving

MS Office

6M/5Whys

Education

Bachelor’s Degree (BS) in a technical field

Job description

Corden Pharma Colorado (CPC) is seeking a Detail-oriented Investigator to manage deviations, write investigations, and support CAPA closure. You will collect data, lead root cause analyses, and coordinate with cross-functional teams to ensure timely, compliant investigations under cGMP guidelines.

You will participate in the Operational Excellence Program, update procedures, and help drive continuous improvement while maintaining high quality and patient safety standards in a fast-paced