Life Sciences - Out of Specification Consultant

Job Description: Out of Specification (OOS) / Investigation / Data Integrity Consultant

Location: 100% Remote, USA
Residency: US Citizen/permanent resident required for US
Status: Independent Contractor Role
Industry Focus: Life Sciences
Keywords: #lifesciences, #consultant, #RAQA

Role Overview

We are seeking experienced independent contractors with a robust background in Regulatory Affairs (RA) and Quality Assurance (QA) within the life sciences industry. This role involves providing expert consulting services in the RA/QA domains, specifically focusing on medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, and cosmetics. The ideal candidate will have significant experience in designing, manufacturing, and monitoring RA/QA under 21 CFR 2XX and 8XX sections, with a deep commitment to patient safety and population health improvement.

Responsibilities

• Consulting & Auditing: Provide expert guidance on regulatory and quality assurance infrastructure, ensuring compliance with relevant regulations and standards.
• Investigation of OOS/OOT Results: Conduct thorough investigations of Out of Specification (OOS) and Out of Trend (OOT) results, considering potential errors in calculation, method/procedure, instrumentation, and sampling.
• Compliance: Ensure adherence to relevant 21 CFR 2XX and 8XX sections.
• Project Leadership: Plan and deliver consulting engagements, often as an individual contributor, but with an emphasis on teamwork.
• Communication: Effectively communicate ideas and solutions to clients and team members.
• Travel: Ability to travel domestically (25% - 50%) and occasionally internationally for client engagements.

Key Investigation Areas

• Calculation Error: Review calculations for accuracy, verify data, recalculate values, and involve a second analyst for independent verification.
• Method/Procedural Error: Examine laboratory procedures, review SOPs, validate methods, assess training adequacy, and recommend procedural adjustments.
• Instrument Error: Assess calibration and maintenance records, conduct performance verification tests, document deviations, and implement corrective actions.
• Sampling Error: Review sampling procedures, check for contamination and proper storage conditions, assess training, and recommend process adjustments.

Person Description

• Confident Communicator: Able to clearly convey ideas and solutions.
• Team Player: Effective in remote team environments.
• Passionate: Dedicated to improving patient and consumer safety.
• Respectful & Flexible: Values colleague contributions and can adapt to unique client challenges.
• Independent Contractor: Already established in a contract role.

Essential Qualifications

• Educational Background: Bachelor's degree in Engineering, Science, or a related Life Sciences field.
• Leadership Experience: Demonstrated progression in responsibilities, such as leading regulatory submissions.
• Industry Experience: Significant RA/QA experience in medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.

Industry Requirements

• Design & Manufacturing: Proficiency in design and manufacturing processes, and interpretation of GMP and other standards.
• Quality Systems: Experience with quality systems planning, design control, and process validation.
• Regulatory Submissions: Skilled in submissions, remediation, clinical evaluations, post-market surveillance, and risk management.
• Standards Compliance: Knowledge of ancillary standards (ISO 17025:2017, ISO 14971:2019, ISO 27001:2013) is advantageous.

Application Instructions

If you meet the qualifications and are passionate about advancing safety and compliance in the life sciences industry, we encourage you to apply for this exciting opportunity. Please prepare a detailed resume highlighting your relevant experience and qualifications, and be ready to discuss your previous projects and roles in regulatory and quality assurance.

We offer competitive compensation rates determined by the specific project, and you will have the opportunity to collaborate with a top-rated team in a dynamic and flexible work environment.