Senior QA Compliance Associate Global Regulatory & CAPA

Alcon MX; Fort Worth (TX); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Retirement plan

Flexible time off

Job summary

Alcon is seeking a Sr. Associate, Quality Assurance Compliance (Professional Path) for the Fort Worth ASPEX Manufacturing Facility.

You will independently coordinate site gap assessments and apply advanced knowledge to support regulatory compliance of Alcon products produced by contract manufacturers. Responsibilities include managing QMS processes to ensure cGMP and ISO compliance, implementing the Quality Strategy, and supporting training and documentation in a regulated environment.

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand, and communicate in English.
• 2 Years of Relevant Experience
• Work Location: Onsite
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

Responsibilities

• Provide tactical site support to ensure compliance with site, Alcon, and international regulations.
• Coordinate site gap assessments and apply advanced knowledge to achieve objectives.
• Support Quality Management System harmonization and standardization.
• Manage Quality Systems Management processes to ensure cGMP and ISO compliance.
• Assist with Quality Strategy implementation and governance processes.

Skills

English fluency

Experience with audits

2 years of relevant experience

Education

Bachelor’s degree or equivalent

Job description

Alcon is seeking a Sr. Associate, Quality Assurance Compliance (Professional Path) for the Fort Worth ASPEX Manufacturing Facility.

You will independently coordinate site gap assessments and apply advanced knowledge to support regulatory compliance of Alcon products produced by contract manufacturers. Responsibilities include managing QMS processes to ensure cGMP and ISO compliance, implementing the Quality Strategy, and supporting training and documentation in a regulated environment.