Senior Quality Assurance Associate

Essential Duties and Responsibilities include:

* Prepare appropriate documentation and execute release of acceptable product lots and vendor materials
* Review completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
* Provide QA input and ensure proper closure of QQS, deviations, investigations and CAPAS. Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition
* Perform vendor audits
* Assist with internal audits
* Assist with FDA and other regulatory agency inspections as needed

Desired Education and Experience:

* Minimum BS/MA with 7+ years in biotech/pharma (Degree in a scientific discipline relevant to the biotechnology industry)
* 7+ years in Quality Assurance for parenteral drug development (device and diagnostics experience is not applicable)
* Experience in both paper and electronic based systems
* Experience in QA requirements for CMC
* Significant experience in dealing with both US and EU Quality requirements
* Experience in audits of external vendors
* Experience in building and maintaining a Quality infrastructure
* Able to span a broad spectrum of QA requirements: CMC, Preclinical and Clinical
* Excellent technical writing and review skills
* Personable and able to build collaborative relationships with vendors and third parties
* Excellent interpersonal skills and ability to work efficiently and productively in a highly dynamic environment
* Ability to thrive in a fast-paced, highly collaborative environment focused on results and the common good.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.