QA Documentation Specialist II – GMP & SOPs

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); Hybrid; USD 33.000 - 37.000; Vollzeit

Zusammenfassung

PCI TRGR Penn Pharmaceutical Services Ltd is seeking a QA Documentation Associate II in San Diego to coordinate the review and approval of GMP documentation across SOPs, batch records, and related materials. You will work with Project Managers and SMEs to revise master batch records for changes and ensure timely project completion.

The role requires 2-4 years in documentation or QA, familiarity with cGMP guidelines, and strong written/verbal communication.

Qualifikationen

• High School Diploma or equivalent required.
• Associates degree preferred.
• 2-4 years of relevant experience in documentation or quality assurance.
• Familiarity with cGMP guidelines.
• Familiar with Microsoft Office applications and data entry.

Aufgaben

• Utilize Quality Management systems and employee resource programs for daily tasks and collaboration.
• Monitors QA and QC databases for trending documentation.
• Coordinates document changes within an electronic document management system.
• Issues batch records, laboratory notebooks, and logbooks for use in GMP production and testing activities.
• Interfaces with document authors and reviewers to process document changes within project timelines and in accordance with established procedures.
• Facilitates client review and approval of documents.
• Ensures proper maintenance of document master copies and original production records.
• Assists with the archival project in accordance with the retention policy.
• Tracks and electronically files document errors for use in document revision.
• Maintains a GMP environment and follows all Standard Operating Procedures (SOPs).
• Regular and reliable attendance on a full-time basis.

Kenntnisse

Detail oriented

Written communication

Verbal communication

Microsoft Office

Data entry

Ausbildung

High School Diploma or equivalent

Associates degree preferred

Tools

Microsoft Office

Jobbeschreibung

PCI TRGR Penn Pharmaceutical Services Ltd is seeking a QA Documentation Associate II in San Diego to coordinate the review and approval of GMP documentation across SOPs, batch records, and related materials. You will work with Project Managers and SMEs to revise master batch records for changes and ensure timely project completion.

The role requires 2-4 years in documentation or QA, familiarity with cGMP guidelines, and strong written/verbal communication.