QMS Investigator II - CGMP Quality & Investigations

PCI Pharma Services; San Diego (CA); On-site; USD 68,998,000 - 77,624,000; Full time

Benefits offered by this job

Health insurance including dental and…

Vision insurance

Paid time off (PTO)

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services in San Diego seeks a QMS Investigator II to support investigations, deviations, CAPAs, change controls, and CGMP documents under moderate supervision. You will author and revise procedures while coordinating reviews across Manufacturing, QC, Microbiology, Facilities and QA.

The role emphasizes aseptic processing, document control, and process improvements, with opportunities to support audits and ensure timely product release.

Qualifications

• Bachelor's degree in Life Sciences or related field preferred or equivalent experience.
• 3-5 years of relevant CGMP experience, Manufacturing preferred.
• Understanding of equipment, systems and technologies to translate to docs.
• Previous experience with investigations preferred.
• Experience writing deviations, CAPA, SOPs, etc. preferred.
• Aseptic processing and compliance experience preferred.
• Solution-based attitude; aseptic gowning a plus.
• Strong listening, English writing and verbal communication skills.
• Independent work ability and proficiency with Word/Excel.

Responsibilities

• Initiates and supports moderately complex investigations and resolution of issues related to QMS and/or Operations/Production.
• Coordinates interdisciplinary teams for investigations, change controls, gap analyses, risk assessments.
• Authors and revises change controls and other technical documentation.
• Manages components of moderately large-scale deviations.
• Tracks and trends documentation and data as specified.
• Maintains a GLP/CGMP environment and follows SOPs.
• Supports client and regulatory audits as needed.
• Regular full-time attendance and professional behavior.

Skills

Attention to detail

English writing

Verbal communication

Education

Bachelor's degree in Life Sciences or related field

3-5 years CGMP experience

Tools

Microsoft Word

Microsoft Excel

Job description

PCI Pharma Services in San Diego seeks a QMS Investigator II to support investigations, deviations, CAPAs, change controls, and CGMP documents under moderate supervision. You will author and revise procedures while coordinating reviews across Manufacturing, QC, Microbiology, Facilities and QA.

The role emphasizes aseptic processing, document control, and process improvements, with opportunities to support audits and ensure timely product release.