QMS Investigator I: CGMP Compliance & Investigations

PCI Pharma Services; San Diego (CA); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Health insurance (dental & vision)

401(k) plan

Flexible spending account

Paid time off

Job summary

PCI Pharma Services in the San Diego area is seeking a QMS Investigator I to support investigations, deviations, and regulatory documentation within a CGMP environment. You will coordinate documentation, assist with audits, and ensure timely closeouts while collaborating across departments.

The role emphasizes accuracy in technical writing, adherence to SOPs, and the ability to work independently or as part of cross-functional teams. Full-time with benefits is offered.

Qualifications

• High School diploma or equivalent; Life Sciences degree preferred
• 1–3 years CGMP manufacturing experience
• Experience with investigations and deviations preferred
• Strong English writing and verbal communication; detail-oriented
• Proficient with Microsoft Office; able to work independently or in a team

Responsibilities

• Initiate and support investigations to resolve production issues
• Author and revise deviations, complaints, and related documents
• Manage components of large-scale deviations
• Track trends of relevant documentation and data
• Maintain a GLP/CGMP environment and follow SOPs
• Assist audits and become familiar with new equipment/systems
• Attend full-time schedule and maintain professional conduct

Skills

English writing

Verbal communication

Attention to detail

Independent worker

Team collaboration

Education

High School diploma or equivalent

Bachelor's degree in Life Sciences preferred

Tools

Microsoft Office

Job description

PCI Pharma Services in the San Diego area is seeking a QMS Investigator I to support investigations, deviations, and regulatory documentation within a CGMP environment. You will coordinate documentation, assist with audits, and ensure timely closeouts while collaborating across departments.

The role emphasizes accuracy in technical writing, adherence to SOPs, and the ability to work independently or as part of cross-functional teams. Full-time with benefits is offered.