Senior Quality Assurance Specialist

Proclinical is currently recruiting for a Quality Assurance Specialist for a global pharmaceutical company located in Brooklyn Park, MN. Successful candidate will be responsible for performing compliance audits, inspection of batch records and associated documentation in support of timely commercial drug substance manufacture.

• Perform daily visual compliance audit walkthrough of the manufacturing areas with a high attention to details using working knowledge of quality concepts and internal procedures and controls.
• Identify cGMP compliance violations and, as necessary, proposes resolutions.
• Perform daily on the floor inspection of completed batch records, instrument and equipment logbooks, and cleaning logs and other GMP documentation for completeness.
• Seek on the floor resolution of minor findings and escalate significant findings to Team Lead or higher.
• Generate daily audit reports and update tracking and trending databases.
• Support GMP compliance with time spent in the Manufacturing environment by providing direct on the floor support to manufacturing on a regular basis.
• Analyze and interpret projects to determine next steps in consultation with management. Make basic decisions independently. Review more complex decisions with management.
• Identify and resolve basic technical issues using problem-solving skills, in consultation with management.
• Receive minimal supervision on routine work assignments. Receive specific instruction on new assignments.
• Identify and propose Quality Process and system improvements.
• Complete mandatory training within required timeframe.
• Perform additional duties, as assigned, including support of Compliance functions.

Skills and Requirements:

• Minimum of BA/BS in any Life Science discipline.
• 3-5+ years' experience in Regulated (food, medical device, or pharma/biotech) industry.
• Understand and apply good working knowledge of quality and GMP principles.
• Experience with the following: Auditing; basic statistics; Internal/External Auditing; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• 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 display eagerness to learn and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement.
• Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
• Must be able to work flexible shifts

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 Nikki Ranieri at (+1) 215-531-5288 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.

Proclinical Staffing is an equal opportunity employer.

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