Laboratory Assistant

Integrated Resources, Inc ( IRI ); Shrewsbury (MA); Presencial; USD 45.000 - 65.000; Jornada completa

Descripción de la vacante

Integrated Resources, Inc ( IRI ) is seeking a Data Reviewer to validate study data for completeness and GLP compliance in a laboratory setting. The role involves ensuring data follows SOPs and regulatory guidelines and collaborating with scientists and QA staff.

The candidate will review paper and electronic data, assist in updating forms, and support training on correct data notation and corrections. This onsite position requires a high school diploma or GED; an associate degree is preferred,

Formación

• High school diploma or GED required; Associate's degree preferred.
• Equivalent combination of education and experience may be accepted.
• Experience with study data review and GLP guidance is a plus.

Responsabilidades

• Review all study data for completeness and GLP compliance.
• Ensure data review follows SOPs and regulatory guidelines.
• Interact with scientists, QA staff, and other departments regarding data.

Conocimientos

Data review

GLP compliance

SOP adherence

Documentation skills

Communication

Educación

High school diploma or GED

Associate's degree preferred

Descripción del empleo

Shift: Monday – Friday, 40-hour work week (Potential for OT but may not be required)

Interview- onsite preferred; 1 round

Job Description:

• Responsible for reviewing all study data to ensure it is complete and GLP compliant.
• Ensure that all data received for review follows SOP and regulatory guidelines that apply to the recording of study data.
• Interact with Scientist, QA staff and other departments with regards to data.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Complete data review on all paper and electronic data produced in operational departments.
• Ensure all forms that require data review and electronic data are in compliance with Standard Operating Procedures (SOPs) and forms are updated as needed.
• Ensure all data corrections are completed by the appropriate staff members and that they are completed correctly.
• Communicate with department management and Scientist regarding any issues related to data collection that impact the recording of data.
• Assist in departmental training by providing assistance with training on correct methods of data notation and correction as it relates to study data review.
• Assist in revising and developing department forms.
• Archive, collate, and organize all completed and reviewed data and/or file as appropriate.
• Collaborate with QA staff to ensure GLPs are being followed for the recording of data.
• Assist with department filing as needed.
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: High school diploma or General Education Degree (G.E.D.) required. Associate's degree preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

PHYSICAL DEMANDS:

• Regularly operates a computer and occasionally operates other office productivity machinery such as a label maker, copy machine, and computer printer.
• Regularly communicates with employees.
• Regularly provides information to and receives information from/through various technologies, media, sources and contacts.
• Must be able to exchange accurate information in these situations.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.
• Regularly moves about inside the office to access file cabinets, office machinery, etc.

WORK ENVIRONMENT:

• General office and laboratory working conditions, the noise level in the work environment is usually quiet.