Manufacturing Investigator I: cGMP Deviations & Documentation

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 26,000 - 30,000; Full time

Job summary

PCI Pharma Services is seeking a Manufacturing Investigator I to support investigations, deviations, and cGMP documentation under direct supervision. This role writes up and revises records, coordinates documentation, and collaborates with multiple departments to resolve issues affecting manufacturing quality.

The position expects strong attention to detail, solid English communication, and the ability to work independently within SOP guidelines.

Qualifications

• Associate’s or bachelor’s degree preferred.
• High School diploma or equivalent required.
• 1-2 years of relevant experience in manufacturing.
• Minimum of 1 year of relevant experience in cGMP environment preferred.
• Previous investigations experience preferred.
• Familiarity with relevant technical documentation (SOPs, preventative actions, deviations, etc.) preferred.
• Detail oriented with strong English writing skills.
• Strong verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Highly proficient with Microsoft Office applications.

Responsibilities

• Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations.
• May support cross-functional teams.
• Authors and revises batch records, deviations, complaints, and other technical documentation.
• Manages specific components of large‑scale deviations.
• Tracks and trends relevant documentation and data as specified.
• Maintains a GLP/cGMP environment and follows SOPs.
• Adjusts responsibilities and activities to meet client and internal expectations.
• Follows up on open documents to ensure timely close out of batch record revisions and investigations.
• Provides support for internal and client audits as needed.
• Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.

Skills

Detail oriented

Strong English writing skills

Strong verbal communication skills

Microsoft Office

Independent worker

Education

Associate’s or Bachelor’s degree preferred

High School diploma or equivalent required

Tools

Microsoft Office

Job description

PCI Pharma Services is seeking a Manufacturing Investigator I to support investigations, deviations, and cGMP documentation under direct supervision. This role writes up and revises records, coordinates documentation, and collaborates with multiple departments to resolve issues affecting manufacturing quality.

The position expects strong attention to detail, solid English communication, and the ability to work independently within SOP guidelines.