QC Stability Consultant – Subject Matter Expert (SME)
Houston, TX
Full Time
Mid Level
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
Qualifications
Preferred Attributes
Contract Details
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.
- 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.
- Bachelor’s or Master’s 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 Q1A–Q1F, 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.
- 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.
- Duration: 3 months with potential for extension
- Work Arrangement: Onsite Monday through Friday
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