Technical Operations I

Proclinical is currently recruiting for a Technical Operations I for a global pharmaceutical company located in Philadelphia, PA. Successful candidate will generate and/or review Manufacturing related technical documents and manage timely closure of these documents.

Job Responsibilities:

• Execute NCE investigations ensuring complete and thorough review and timely closure (target <30 days from initiation).
• Manage changes having GXP impact including process, equipment, and facility changes through the company's Change Control process.
• Maintain quality metrics around NCEs and Change Controls.
• Evaluate trends in NCEs and recommend CAPAs.
• Provide support writing BRs, TTs, FRs, and SOPs as needed.
• Work with appropriate departments for efficient management of NCEs and CCs. This includes QA, Metrology, Validation, Facilities, and Manufacturing.
• Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Contribute to the overall operations and to the achievement of departmental goals.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.

Skills and Requirements:

• Bachelors' degree or equivalent experience.
• 0-2 years of relevant experience or equivalent.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
• Ability to work in a team environment and independently as required.

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 Mike Raletz at (+1) 267-428-7770 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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