Senior QA Specialist - cGMP, Hybrid, Pharma

Galderma Laboratories; Fort Worth (TX); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Job summary

Galderma Laboratories in Fort Worth, TX (Hybrid) is seeking a Senior Quality Assurance Specialist to provide QA oversight across cGMP areas including packaging, labeling, and batch disposition.

The role collaborates with manufacturing sites to resolve quality issues, participates in CAPA, change control, and regulatory readiness, and ensures documentation meets requirements for inspections and audits.

Qualifications

• Bachelor's degree required.
• 5–7 years of QA experience in a regulated environment.
• Knowledge of applicable GXP regulations.
• Knowledge of auditing techniques.
• Working knowledge of computer software.
• Strong organizational and communication skills.
• Ability to manage multiple tasks.
• Good writing skills.

Responsibilities

• Quality release process for finished product distribution, including visual inspection for US market.
• Manage temperature monitoring program for the distribution center and shipments.
• Work with manufacturing sites to resolve quality issues such as complaints and storage conditions.
• Review artwork and rework instructions to ensure cGMP compliance.
• Participate in cross-functional projects to support new products or changes.
• Support inspections by regulatory agencies and ensure readiness.
• Provide guidance on remediation activities to maintain operations.
• Escalate critical issues to senior management when needed.
• Drive continuous improvement through monthly quality meetings.

Skills

QA experience

GXP knowledge

Auditing techniques

Communication skills

Organization skills

Multitasking

Technical writing

Computer literacy

Education

Bachelor's degree

Job description

Galderma Laboratories in Fort Worth, TX (Hybrid) is seeking a Senior Quality Assurance Specialist to provide QA oversight across cGMP areas including packaging, labeling, and batch disposition.

The role collaborates with manufacturing sites to resolve quality issues, participates in CAPA, change control, and regulatory readiness, and ensures documentation meets requirements for inspections and audits.