QC Stability Consultant – Subject Matter Expert (SME)

Houston, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

This is a 1099 Contract opportunity with no benefits. Approx. 3-month contract.

Position Summary
The QC Stability Consultant SME will serve as a subject matter expert supporting the design implementation and continuous improvement of the pharmaceutical stability program. This role provides strategic and technical expertise to ensure compliance with global regulatory requirements (FDA EMA ICH WHO) and company quality standards. The consultant will partner cross-functionally with Quality Control Quality Assurance Regulatory Affairs and Manufacturing to maintain the integrity and scientific rigor of the stability program.

Key Responsibilities

Lead and advise on all aspects of stability study design execution and data interpretation in accordance with ICH guidelines and company SOPs.
Review and approve stability protocols reports and trend analyses for new and existing products.
Assess and optimize current stability program systems workflows and documentation for regulatory compliance and efficiency.
Provide technical guidance during audits inspections and regulatory submissions.
Develop and deliver training for QC and QA personnel on stability testing procedures and data management.
Evaluate and support implementation of digital tools or LIMS enhancements for stability management.
Support investigations and CAPAs related to stability data deviations or OOS results.
Collaborate with product development teams to ensure appropriate stability testing during lifecycle management and change control.

Qualifications

Bachelors or Masters degree in Chemistry Pharmaceutical Sciences or related field (Ph.D. preferred).
Minimum of 10 years of experience in pharmaceutical Quality Control with at least 5 years focused on stability programs.
Deep knowledge of ICH Q1AQ1F GMP regulations and related global stability guidelines.
Proven experience preparing and defending stability data in regulatory audits and submissions.
Strong analytical problem-solving and project management skills.
Excellent written and verbal communication skills.
Experience with LIMS Empower or other electronic data management systems preferred.

Preferred Attributes

Demonstrated leadership in implementing or remediating global stability programs.
Experience with biologics or sterile drug products.
Ability to manage multiple priorities in a fast-paced regulated environment.
Strong interpersonal skills and the ability to influence cross-functional teams.

Contract Details

Duration: 3 months with potential for extension
Work Arrangement: Onsite Monday through Friday

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Required Experience:

Manager

Key Responsibilities

Lead and advise on all aspects of stability study design execution and data interpretation in accordance with ICH guidelines and company SOPs.
Review and approve stability protocols reports and trend analyses for new and existing products.
Assess and optimize current stability program systems workflows and documentation for regulatory compliance and efficiency.
Provide technical guidance during audits inspections and regulatory submissions.
Develop and deliver training for QC and QA personnel on stability testing procedures and data management.
Evaluate and support implementation of digital tools or LIMS enhancements for stability management.
Support investigations and CAPAs related to stability data deviations or OOS results.
Collaborate with product development teams to ensure appropriate stability testing during lifecycle management and change control.

Qualifications

Bachelors or Masters degree in Chemistry Pharmaceutical Sciences or related field (Ph.D. preferred).
Minimum of 10 years of experience in pharmaceutical Quality Control with at least 5 years focused on stability programs.
Deep knowledge of ICH Q1AQ1F GMP regulations and related global stability guidelines.
Proven experience preparing and defending stability data in regulatory audits and submissions.
Strong analytical problem-solving and project management skills.
Excellent written and verbal communication skills.
Experience with LIMS Empower or other electronic data management systems preferred.

Preferred Attributes

Demonstrated leadership in implementing or remediating global stability programs.
Experience with biologics or sterile drug products.
Ability to manage multiple priorities in a fast-paced regulated environment.
Strong interpersonal skills and the ability to influence cross-functional teams.

Contract Details