Quality Control Project Lead - Transfer & Compliance

Lonza; Houston (TX); Sur place; Confidential; Plein temps

Avantages offerts par ce poste

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Résumé du poste

Lonza in Houston, TX is seeking a Quality Control Project Lead to drive tech transfer activities and maintain rigorous QC standards. The role requires leading project teams, writing and reviewing QC documentation, and ensuring regulatory alignment with cGMP practices.

The candidate will collaborate with QA, MSAT, and manufacturing while supporting stability programs and deviations investigations. On-site role with market-competitive benefits and growth opportunities.

Qualifications

• 3–5 years of experience in Quality Control.
• Strong understanding of cGMP principles and regulatory compliance.
• Experience with method validation/qualification and technology transfer in a QC environment.
• Excellent written and verbal communication skills.

Responsabilités

• Lead tech transfer activities including development of transfer plans, protocols, and reports.
• Provide QC representation in project team meetings and communicate project status and timelines.
• Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
• Write, review, and approve test records, sampling plans, specifications, and QC documentation.
• Support stability programs and track testing progress and deliverables.
• Collaborate with cross-functional teams including QA, MSAT, and manufacturing.
• Assist with deviations, OOS investigations, CAPAs, and audit responses.

Connaissances

Quality Control

Project management

Communication

Regulatory compliance

Formation

Bachelor's degree (scientific field)

Description du poste

Lonza in Houston, TX is seeking a Quality Control Project Lead to drive tech transfer activities and maintain rigorous QC standards. The role requires leading project teams, writing and reviewing QC documentation, and ensuring regulatory alignment with cGMP practices.

The candidate will collaborate with QA, MSAT, and manufacturing while supporting stability programs and deviations investigations. On-site role with market-competitive benefits and growth opportunities.