QA Specialist II- Pharmaceutical Quality Systems

Aerotek Scientific currently has a few QA Specialist positions available with a large pharmaceutical client for a long term contract position.

Candidates with 5+ years of QA experience in the pharmaceutical or medical device industries are ideal.

Qualified candidates are encouraged to email resumes directly to Amy Nguyen.

QA Specialist - Shift - Monday - Friday 8AM -5PM with OT.

• Performs a variety of activities to ensure compliance with applicable regulatory requirements.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
• Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May support in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May assist lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.
• May work with Research and Development during new product start-ups, with guidance from senior colleagues.
• Normally receives general instruction on routine work, detailed instructions on new assignments.

Demonstrates knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks.

Demonstrates analytical problem solving skills.

Demonstrates ability to explain complex concepts with clarity and simplicity.

Demonstrates ability to perform detail-oriented work with a high degree of accuracy.Demonstrates strong verbal, written, and interpersonal communication skills.

Demonstrates proficiency in Microsoft Office applications and Adobe Acrobat Professional.

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

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