QA SPECIALIST II

Proclinical is currently seeking a Quality Assurance Specialist for a pharmaceutical company located in Brooklyn Park, MN. Successful candidate will be responsible for reviewing validation documents and other related documents for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.

Job Responsibilities:

• Performing Quality Assurance activities associated with commercial cGMP biologics drug substance manufacture.
• Aiding site personnel performing deviation investigations, CAPAs and change controls.
• Performing documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
• Providing support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable, and consistent operation of the system.
• Analyzing and interpreting projects, studies, or investigations to determine next steps in consultation with Supervisor. Making basic decisions independently. Reviewing more complex decisions with management.
• Identifying and resolving basic technical issues using problem-solving skills, in consultation with Supervisor.
• Independently revising department-specific controlled documents.
• Participating in required training and keeps training files current.
• Performing additional duties, as assigned.

Skills and Requirements:

• BS or MS in any Life Science discipline preferred and/or 3-5 years' experience in Regulated industry.
• Understands and applies good working knowledge of quality and GMP principles.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
• Must be able to read, write and converse in English.
• Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
• Must be able to work in controlled or clean room environments requiring special gowning.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sherron Howard at (+1) 267-435-8600 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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