JobDescription : Out of Specification (OOS) / Investigation / DataIntegrity Consultant

Location : 100% RemoteUSA

Residency : USCitizen / permanent resident required forUS

Status : IndependentContractor Role

IndustryFocus : LifeSciences

Keywords : #lifesciences #consultant #RAQA

Role Overview

We are seeking experienced independent contractors with arobust background in Regulatory Affairs (RA) and Quality Assurance(QA) within the life sciences industry.

This role involvesproviding expert consulting services in the RA / QA domainsspecifically focusing on medical devices in vitro diagnosticslabdeveloped tests pharmaceuticals and cosmetics.

The idealcandidate will have significant experience in designingmanufacturing and monitoring RA / QA under 21 CFR 2XX and 8XXsections with a deep commitment to patient safety and populationhealth improvement.

Responsibilities

• Consulting &Auditing : Provide expert guidance on regulatory andquality assurance infrastructure ensuring compliance with relevantregulations andstandards.
• Investigation ofOOS / OOT Results : Conduct thorough investigations ofOut of Specification (OOS) and Out of Trend (OOT) resultsconsidering potential errors in calculation method / procedureinstrumentation andsampling.
• Compliance : Ensure adherence to relevant 21 CFR 2XX and 8XXsections.
• ProjectLeadership : Plan and deliver consulting engagementsoften as an individual contributor but with an emphasis onteamwork.
• Communication : Effectively communicate ideas and solutions to clients and teammembers.
• Travel : Ability to travel domestically (25% 50%) and occasionallyinternationally for client engagements.

Key InvestigationAreas

• Calculation Error : Review calculations for accuracy verify data recalculate values andinvolve a second analyst for independentverification.
• Method / ProceduralError : Examine laboratory procedures review SOPsvalidate methods assess training adequacy and recommend proceduraladjustments.
• InstrumentError : Assess calibration and maintenance recordsconduct performance verification tests document deviations andimplement correctiveactions.
• SamplingError : Review sampling procedures check forcontamination and proper storage conditions assess training andrecommend process adjustments.

Person Description

• ConfidentCommunicator : Able to clearly convey ideas andsolutions.
• TeamPlayer : Effective in remote teamenvironments.
• Passionate : Dedicated to improving patient and consumersafety.
• Respectful &Flexible : Values colleague contributions and canadapt to unique clientchallenges.
• IndependentContractor : Already established in a contractrole.

EssentialQualifications

• EducationalBackground : Bachelors degree in Engineering Scienceor a related Life Sciencesfield.
• LeadershipExperience : Demonstrated progression inresponsibilities such as leading regulatorysubmissions.
• IndustryExperience : Significant RA / QA experience in medicaldevices in vitro diagnostics pharmaceuticals orcosmetics.

IndustryRequirements

• Design &Manufacturing : Proficiency in design andmanufacturing processes and interpretation of GMP and otherstandards.
• QualitySystems : Experience with quality systems planningdesign control and processvalidation.
• RegulatorySubmissions : Skilled in submissions remediationclinical evaluations postmarket surveillance and riskmanagement.
• StandardsCompliance : Knowledge of ancillary standards (ISO17025 : 2017 ISO 14971 : 2019 ISO 27001 : 2013) isadvantageous.

ApplicationInstructions

If you meet thequalifications and are passionate about advancing safety andcompliance in the life sciences industry we encourage you to applyfor this exciting opportunity.

Please prepare a detailed resumehighlighting your relevant experience and qualifications and beready to discuss your previous projects and roles in regulatory andquality assurance.

RemoteWork :

Last updated : 2024-08-12