Quality Systems Investigator I

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Health insurance coverage (dental &amp

Flexible spending account

401(k) plan

Paid time off

Job summary

PCI Pharma Services is seeking a CGMP Investigator I in San Diego, CA to support investigations, deviations, and technical documentation under direct supervision. You will collaborate with cross-functional teams, review batch records, and ensure compliance with SOPs in a fast-paced manufacturing environment.

The role emphasizes accuracy, timely closure of records, and professional communication. A Life Sciences degree with 1–3 years CGMP experience is preferred; MS Office proficiency is

Qualifications

• High School diploma or equivalent required.
• Bachelor's degree in Life Sciences or related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
• 1-3 years of relevant experience in a CGMP environment, Manufacturing preferred.
• Previous experience with investigations preferred.
• Familiarity with relevant technical documentation (deviations, corrective and preventative actions, SOPs, 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/Production.
• May support cross-functional teams.
• Authors and revises 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/records to ensure timely close out of batch record revisions and investigations.
• Provides support for internal, client, and regulatory audits as needed.
• Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
• Performs other duties as assigned to support departmental and organizational objectives.

Skills

CGMP environment

Investigations

Technical documentation

Written communication

Team collaboration

MS Office

Attention to detail

English writing skills

Education

Bachelor's degree in Life Sciences

Tools

Document control systems

Job description

PCI Pharma Services is seeking a CGMP Investigator I in San Diego, CA to support investigations, deviations, and technical documentation under direct supervision. You will collaborate with cross-functional teams, review batch records, and ensure compliance with SOPs in a fast-paced manufacturing environment.

The role emphasizes accuracy, timely closure of records, and professional communication. A Life Sciences degree with 1–3 years CGMP experience is preferred; MS Office proficiency is