Job ID

2022-1705

Category

Administrative

Location : Location

US-NM-Albuquerque

Type

Full-time

Division

Lovelace Biomedical Research Institute (LBRI)

The Compliance and Validation Specialist is responsible for assuring data integrity and associated validations of data generating and data management systems including compliance with FDA 21CFR Part 11 regulation, as well as various levels of validation of laboratory equipment, as required.

 

The Compliance and Validation Specialist will work directly with scientific, quality and IT compliance staff to gather user requirements, assure change control of systems and all associated infrastructure along the data path, and generally assure compliance with applicable SOPs and regulations. During selection, identification and purchase of new software systems this position assists as necessary in capturing requirements, establishing infrastructure needs, and ensuring hardware/software compatibility. This position is responsible for drafting appropriate validation requirements/plans/scripts and performing validation testing and drafting validation reports, for electronic systems and for laboratory equipment, as necessary. Throughout all functions this position is responsible for conduct and documentation of all activities within the scope of current SOP and regulatory guidance.

Requires a Bachelor’s degree and at least one year experience with scientific software (eg. Empower, Analyst, Chemstation, Mass Lynx, WinNonlin, emka, or Provantis), laboratory equipment (ie. refrigerators, freezers, incubators) and associated monitoring interfaces (ie REES environmental monitoring system), and/or vendors of software/equipment in a regulated environment; or an equivalent combination of education, training and/or experience from which comparable knowledge; skills and abilities have been attained.  Experience should include installation, operation and support of regulated software systems or equipment designed to capture, manage and process scientific data.

As Lovelace is a Federal Contractor, all applicants offered positions with the Institute are required to show proof of full COVID-19 vaccination prior to starting employment.

Salary is commensurate with experience.

 

EEO - M/F/Veteran/Disability

 

Equal Opportunity Employer

The Lovelace Biomedical Research Institute Companies are an Equal Opportunity employer-M/F/Veteran/Disability. We are committed to the hiring, advancement and fair treatment of all individuals, and all qualified applicants will receive consideration for employment without regarding to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, protected veteran status, or any other protected status as designated by federal, state or local law. All applicants and employees are further protected from discrimination based on inquiring about, disclosing or discussing the compensation of other applicants or employees. For additional information about your rights as an applicant, click here.

For assistance with our application process, including reasonable accommodations for individuals with disabilities to participate in the application process, please send an email to recruiting@lovelacebiomedical.org or call 505-348-9400.