QA Documentation Associate II

PCI Pharma Services • San Diego, CA

7d • Onsite

About The Position

The QA Documentation Associate II will coordinate the review and approval of SOP’s, master batch records, methods, material specifications, protocols, reports and other GMP documentation using an electronic document management system. The role will work with Project Managers and Subject Matter Experts to revise existing master batch records for process change, corrective actions, and clerical document errors. The QA Documentation Associate II also supports administrative responsibilities for the team, including scanning documentation, maintaining spreadsheets for in-process projects, and manage the archival of company documents.

Requirements

• High School Diploma or equivalent required
• Minimum of 2-4 years of relevant experience in documentation, quality assurance or equivalent.
• Familiarity with cGMP guidelines.
• Familiar with Microsoft Office applications and data entry.
• Ability to work independently or as a team member.
• Detail oriented and strong written and verbal communication skills.

Nice To Haves

• Associates degree preferred.

Responsibilities

• 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 (SOP’s).
• 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 Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

Benefits

• paid time off
• health insurance coverage (including dental and vision)
• a flexible spending account
• a 401(k) plan
• annual performance bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED