Quality Lab Associate I

Stefanini Group is hiring!

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Summary:

Conduct biological chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods and environmental monitoring programs.

The Essential Roles and Responsibilities:

The incumbent will perform other duties assigned:

• Conduct critical biological chemical and physical analyses on raw materials initial in-process and final products and samples collected from environmental monitoring programs at companys manufacturing facilities. Work under minimum supervision.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs and specifications FDA GLP QSR and cGMP regulations.
• Investigate deviations and write exception documents.
• Participate in functions involving teams which impact production increase efficiency solve problems generate cost savings and improve quality.
• Perform laboratory and manufacturing audits as required. Audit and update as required plant SOPs.
• Perform equipment maintenance and calibrations as required.

Qualifications:

• Ability to handle multiple tasks concurrently and in a timely fashion.
• Computer literate.
• Must be detail oriented conscientious and have high reading comprehension skills.
• Must have basic understanding of laboratory instrumentation.
• Must be able to communicate effectively with supervisors and peers.

Education and Experience:

Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives

About Stefanini Group

The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas Europe Africa and Asia and more than 400 clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with global presence. We are CMM Level 5 company.

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