Deviation Investigator Associate — Pharma Quality & CAPA

CordenPharma International; Hygiene (CO); Presencial; USD 77 000 - 96 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) matching

Health Insurance PPO/HSA

Disability Insurance

Employee Assistance Program

Flexible Spending Account

Health Insurance PPO/HSA

Hospital Indemnity Plan

ID Theft Protection

Life Insurance

Paid Maternity/Paternity Leave

Tuition Reimbursement

Wellness Program

Vision Insurance

Resumo da oferta

CordenPharma Colorado is seeking a Tech Operations Manager to lead deviations, investigations, and CAPA processes ensuring on-time completion and data-driven root cause analysis. You will collaborate with cross-functional teams to gather data, document impact, and drive continuous improvement through the Operational Excellence program.

The role requires a bachelor’s degree in a technical field and 2 years of pharmaceutical manufacturing experience, with strong writing and analytical skills in

Qualificações

• Bachelor’s Degree in a technical field and 2 years Pharmaceutical Manufacturing experience.
• Ability to read, analyze, and interpret procedures, technical data, and governmental regulations.
• Ability to write reports, business correspondence, and procedures/technical documents. Ability to speak, read and write in English.

Responsabilidades

• Responsible for on time completion and writing of deviations, laboratory investigations, and/or assigned corrective/preventive actions.
• Lead manufacturing or laboratory investigations with minimal guidance.
• Work with cross functional teams to collect data and conduct interviews after a deviation; identify and document deviation impact.
• Lead root cause analysis to determine most likely root cause/contributing factors for a deviation.
• Ensure deviation includes documented justification for impact on materials, product, or system within scope of the deviation.
• Facilitate meetings to drive internal alignment on investigational path forward.
• Identify and communicate observed trends to drive system process improvements.
• Progress multiple projects and deviations simultaneously.
• Collaborate with customers for correction resolution on deviation drafts.
• Participate in the Corden Operational Excellence Program to drive continuous improvement.
• Update procedures/documentation to address CAPAs.
• Perform investigations in compliance with applicable procedures.

Formação académica

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

Descrição da oferta de emprego

CordenPharma Colorado is seeking a Tech Operations Manager to lead deviations, investigations, and CAPA processes ensuring on-time completion and data-driven root cause analysis. You will collaborate with cross-functional teams to gather data, document impact, and drive continuous improvement through the Operational Excellence program.

The role requires a bachelor’s degree in a technical field and 2 years of pharmaceutical manufacturing experience, with strong writing and analytical skills in