What are the responsibilities and job description for the Quality Lab Associate II position at Jobs via Dice?
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Summary:
Conduct biological, chemical and physical analyses on pharmaceutical products 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:
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. 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 the environmental monitoring programs at manufacturing facility. Work under minimum supervision.Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required.Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.Use sophisticated laboratory instrumentation and computer systems to collect and record data.Perform advanced biological and chemical 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.Proficient in wet and instrumental methods of analyses.Advanced laboratory skills, basic knowledge of statistical method.Strong technical problem-solving skills. Ability to handle multiple tasks concurrently, and in a timely fashion.Computer literate.Must be able to communicate effectively with supervisors and peers.Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.
Education and Experience:Bachelor's Degree in Chemistry or Biological Sciences with Analytical Chemistry or Laboratory coursework, along with 2-5 years of experience; orMaster's Degree in Chemistry or Biological Sciences with 0-3 years of 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.
Stefanini Group is hiring!
Exciting opportunity awaits, let us help you get started!
Click Apply now or you may call Sahnaj Pervin at or email at for faster processing!
Summary:
Conduct biological, chemical and physical analyses on pharmaceutical products 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:
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. 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 the environmental monitoring programs at manufacturing facility. Work under minimum supervision.Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required.Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.Use sophisticated laboratory instrumentation and computer systems to collect and record data.Perform advanced biological and chemical 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.Proficient in wet and instrumental methods of analyses.Advanced laboratory skills, basic knowledge of statistical method.Strong technical problem-solving skills. Ability to handle multiple tasks concurrently, and in a timely fashion.Computer literate.Must be able to communicate effectively with supervisors and peers.Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.
Education and Experience:Bachelor's Degree in Chemistry or Biological Sciences with Analytical Chemistry or Laboratory coursework, along with 2-5 years of experience; orMaster's Degree in Chemistry or Biological Sciences with 0-3 years of 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.