QA Associate (Part-Time)

Located in Durham, NC

Salary: $55,000 annually

Schedule: 

• Part-time, hourly position, approximately 20 hours per week.
• Hybrid position – some projects can be done at home.

Responsibilities:

• Reviewing data and batch records and helping maintain all company Standard Operating Procedures (SOPs), work instructions, and quality records.
• Oversee the routing of controlled documents through their lifecycle – including creation, review, approval, distribution, revision, and secure archiving.
• Facilitate high-level cross-functional QA review of controlled documents.
• Work independently.
• Tasks will be explained and set up ahead of time and will be executed with minimal supervision.
• Track and archive completed quality records, training logs, and batch documentation.
• Track metrics related to document reviews, cycle times, and overdue document revisions.

Skills Required:

• Quality: ALCOA+ documentation and experience with controlled batch records.
• Attention to Detail: Ability to perform tasks consistently and correctly
• Computer and Technical Skills: Embrace and adapt to technology required to fulfill responsibilities of this position, including but not limited to: Microsoft Word, Excel, Outlook, PowerPoint, Teams, and Project Management software.

Education Required: 

• Associate’s or Bachelor’s degree in Quality Management or a relevant scientific field.
• 1-3+ years of experience working in QA, document control, or records management within pharmaceutical, biotechnology, or associated field.

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