Deviation Investigator Associate, CAPA & Investigations

CordenPharma International; Boulder (CO); On-site; USD 77,000 - 96,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Tuition Reimbursement

Wellness Program

Vision Insurance

Job summary

CordenPharma Colorado is seeking a Tech Operations Manager to oversee investigations into deviations, draft corrective/preventive actions, and ensure on-time completion of QA investigations. You will work with supervisors and operators to collect data and support root cause analysis.

You will lead cross-functional teams, participate in the Operational Excellence Program, and drive continuous improvements while ensuring compliance with cGMP and regulatory standards.

Qualifications

• BS in a technical field and 2 years pharmaceutical manufacturing experience.
• Ability to read, analyze, and interpret procedures and write reports.
• Knowledge of cGMP, FDA and ICH guidelines as part of quality systems.

Responsibilities

• Initiation, completion, drafting, and on-time closure of investigations assigned.
• Work with cross-functional teams to collect data and document deviation impact.
• Lead root cause analysis to determine contributing factors for deviations.
• Gather and interpret data to justify impact on materials, products, or systems.
• Facilitate meetings to align review teams on investigative paths.
• Identify trends to drive system/process improvements.
• Manage multiple projects and deviations concurrently.
• Collaborate with customers for correction/resolution on drafts.
• Participate in Operational Excellence Program to drive improvements.
• Update procedures/documents to address CAPAs.
• Perform investigations per CordenPharma procedures.

Skills

Technical writing

Root cause analysis

Cross-functional teamwork

Education

Bachelor's Degree in a technical field

Tools

Microsoft Office

Job description

CordenPharma Colorado is seeking a Tech Operations Manager to oversee investigations into deviations, draft corrective/preventive actions, and ensure on-time completion of QA investigations. You will work with supervisors and operators to collect data and support root cause analysis.

You will lead cross-functional teams, participate in the Operational Excellence Program, and drive continuous improvements while ensuring compliance with cGMP and regulatory standards.