QMS Investigator I

PCI Pharma Services•San Diego, CA

About The Position

Under direct supervision, the QMS Investigator I supports investigations and the resolution of issues or risks related to Manufacturing and Operations/Production. The role may investigate, author, coordinate, and revise deviations, corrective and preventative actions, complaints, Master Production Batch Records, and other cGMP documentation. It supports simple write-ups, manages specific components of large-scale deviations, and may coordinate the review, revision, and approval of procedures and associated documentation. The position works with multiple departments and may support cross-functional teams. The investigator tracks and trends relevant documents and data, follows up on open records to ensure timely closeout, maintains a GLP/cGMP environment, and follows SOPs. The role also supports internal, client, and regulatory audits as needed, and becomes familiar with new equipment, systems, and technologies to maintain accurate documentation. This is an evergreen posting to build a pipeline of qualified candidates for current and future opportunities; candidates may be contacted as business needs arise.

Requirements

High school diploma or equivalent required.
1–3 years of relevant experience in a cGMP environment; Manufacturing experience 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.

Nice To Haves

Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and/or relevant work experience.
Manufacturing experience.
Previous experience with investigations.
Familiarity with relevant technical documentation, including deviations, corrective and preventative actions, and SOPs.

Responsibilities

Under direct supervision, initiate and support timely investigations and resolution of issues related to Operations/Production.
Support cross-functional teams as needed.
Author and revise deviations, complaints, and other technical documentation.
Manage specific components of large-scale deviations.
Track and trend relevant documentation and data as specified.
Maintain a GLP/cGMP environment and follow SOPs.
Adjust responsibilities and activities to meet client and internal expectations.
Follow up on open documents and records to ensure timely closeout of batch record revisions and investigations.
Provide support for internal, client, and regulatory audits as needed.
Become familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
Follow PCI EHS policies and procedures to foster a safe and environmentally sustainable workplace.
Exhibit professional behavior with internal and external business associates, align daily actions with department goals and company culture, and perform other duties as assigned.