Job Title: Quality Assurance Associate

Job Description

We are seeking a dedicated Quality Assurance Associate for a temporary 6-month position to address documentation backlog. The role involves scanning and filing all types of documentation, including employee records, validation, and batch records, ensuring data integrity. You will issue logbooks and notebooks, navigate the company network and offsite storage for electronic documents, and update tracking systems. Coordination and organization of onsite and offsite storage as per retention requirements are also part of the duties.

Responsibilities

• Scan and file all documentation, ensuring verification for data integrity.
• Issue logbooks and notebooks upon request.
• Navigate company network and offsite storage database for electronic document storage.
• Update and maintain tracking systems.
• Coordinate and organize onsite and offsite storage according to retention requirements.
• Help coordinate the offsite storage room including destruction of sensitive QA documents.
• Issue new lab notebooks to lab and quality employees.
• Understand and follow SOPs and procedures for regulated documents in a cGMP regulated facility.

Essential Skills

• Proficiency in quality assurance documentation and compliance documents.
• Experience with EQMS systems such as Trackwise and Master Control.
• Background in batch record review.
• Knowledge of FDA Good Manufacturing Practices (cGMP).
• Proficient in MS Office Suite.
• Excellent organizational skills.
• Effective verbal and written communication skills.
• Ability to focus on detail-oriented, repetitive tasks.

Additional Skills & Qualifications

• High school diploma or GED required.
• Some college level coursework preferred.
• Two or more years of experience in an administrative position.
• Experience in GMP or cGMP regulated environment preferred.

Work Environment

The work schedule is Monday through Friday, from 8am to 5pm, and requires on-site presence only.