Quality Lab Associate I

Job Description
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 company's 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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Qualifications
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• 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

• Bachelor's degree in chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework and 0-2 years' 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.