QA Documentation Associate I - 1st Shift
PCI Pharma Services · San Diego, CA · 3 wk ago
Quality AssuranceFull-time
About the role
The QA Documentation Associate I coordinates the review and approval of select GMP document types using an electronic document management system. This role manages the archival of company documents and supports documentation processes within GMP production and testing activities.
Responsibilities
- 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.
- Reviews QA/QC databases for trending documentation.
- 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.
- Exhibits professional behavior with both internal and external business associates, reflecting positively on the company.
- Maintains regular and reliable attendance on a full-time basis in accordance with the posted schedule.
- Aligns daily actions with department goals and company culture.
Requirements
- High School Diploma or equivalent (required).
- Associate degree (preferred).
- Zero to two (0–2) years of relevant experience in documentation.
- Familiarity with Microsoft Office Suite and data entry.
Pay
The hiring rate for this position is $19.54–$21.98 per hour, plus eligibility for an annual performance bonus. Final offer amounts are determined by factors including experience, education, credentials, geography, and expertise.
Benefits
- Paid time off.
- Health insurance coverage (including dental and vision).
- Flexible spending account.
- 401(k) plan.
Schedule
1st Shift, 9 AM start time.