Validation Associate

Alturas Analytics, Inc. is seeking a full-time detailed-oriented, Validation Associate.

Reporting to the Director of Information Technology, the Validation Associate is responsible for software validation activities. The validation process involves drafting testing plans for formally documented black box testing of computerized systems (software) and executing such plans to help Alturas Analytics achieve regulatory compliance. Attention to detail is a must. The Validation Associate may work under pressure of release deadlines.

Position Summary

The Validation Associate provides support to Alturas Analytics in computerized system validation. The Validation Associate may provide support to laboratory operations with scientific software at the application level.

Essential Duties and Tasks

• Develops user requirements for computerized systems based on vendor documentation, feedback from end users and good understanding of end users’ workflows, processes and procedures
• Follows Alturas SOPs and industry standards for validation of computerized systems
• Drafts test protocol and scripts, validation plans, and validation summary reports
• Reviews, verifies, and executes test scripts
• Reviews and addresses execution findings
• Safe keeps validation related documents including Change Control forms
• Obtains signatures from reviewers and approvers and assembles validation package for archival
• Drafts end user training materials and scope; provides end user training; and documents training records
• Coordinates with IT, end users, QC, QA and TFM to determine release time of validated systems
• Works with Applications Associate to understand Alturas’ needs and priorities in computerized systems
• Assists in drafting and revising Alturas SOPs on validation of computerized systems

• Escalates to vendor support or IT troubleshooting as appropriate
• Performs other duties as needed or assigned

Education and Experience Requirements

• Bachelor’s degree in science, engineering or related field
• 2-3 years of work experience
• An equivalent combination of education and experience may qualify the appropriate personnel for this position

Skills and Abilities Requirements

• Excellent technical writing skills
• Exemplary verbal and written communication skills
• Good understanding of 21 CFR Part 11 (can be obtained with on-the-job training)
• Working knowledge of Microsoft Office products and Adobe Acrobat for word processing
• Good understanding of computer software
• Good knowledge of scientific instrumentation hardware and software is a plus
• Previous experience in a chemistry or bioanalytical laboratory testing facility is preferred

Physical Requirements

• Must be able to alternate sitting and standing for up to 8 hours per day
• Must be able to sit in front of a computer monitor for up to 8 hours per day
• Position requires talking or hearing less than 1/3 of the time
• Position requires lifting up to 30 lbs. less than 1/3 of the time

Alturas Analytics, Inc. is a bioanalytical laboratory providing expert GLP and Non-GLP LC-MS/MS and GC-MS/MS quantitation and PK/TK analytical services in both small and large molecules. We are a growing, privately-owned CRO specializing in method development, validation, and sample analysis in all biological matrices in support of therapeutic development programs. Our staff consists of talented and hard-working individuals who are dedicated to working with our collaborators to aid in the treatment and cure of disease.

Please submit cover letter and resume to be considered.

For complete job description and information about our company, please visit our website: https://alturasanalytics.com/company/careers/

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental Pay:

• Bonus pay

COVID-19 considerations:
Alturas is committed to maintaining a safe workplace for all our employees and all those who visit our site. Because of this, all employees are required to wear a mask while working indoors and in close contact with others.

Education:

• Bachelor's (Required)

Work Location: One location