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Form of workAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. Join our team to help people #SeeBrilliantly!
We foster an inclusive culture and looking for diverse, talented people to join Alcon and we are hiring for a Sr. Compliance Specialist, Distribution in Fort Worth, TX, where you will be responsible for ensuring services, processes, and facilities are in compliance with the organization's Quality Assurance (QA) standards, international standards, and government regulations. This person also establishes quantitative measurements and techniques for measuring quality and drives improvements, conducts process quality audit and documents inspection records. This position requires understanding of external standards such as International Organization for Standardization (ISO), Lean Six Sigma for quality in their industry field.
Job Description
Lead and execute routine and nonroutine compliance activities to include Change Control, Audit Management, Quality Metrics, Document management and review of regulatory documentation such as Annual Product Quality Reviews, Submissions, Re-registrations, market extensions and quality assessments. Also responsible to provide technical expertise on compliance matters during various cross-functional team meetings or interactions and drive quality improvement projects.
Accountabilities
- Management of external audit activities including and not limited to ensuring site preparedness by site walkthroughs, site personnel training and coaching, coordination of effective CAPA and effectiveness check plan and follow up to ensure timely CAPA closure.
- Coordinate the effective implementation and support of Change Control Management.
- Control and management of document lifecycle in plant document control system.
- Perform various compliance activities that ensure required quality and safety standards are met for our products.
- Provide guidance to cross-functional team such as manufacturing, MS&T, Quality control (QC) laboratories etc.
- Act as subject matter expert (SME) on Quality topics such as Annual product quality review, Change Control.
- Review, approve and provide meaningful feedback on manufacturing, QC, MS&T documentation where necessary.
- Perform compliance activities of complex nature as per schedule and per standards/SOPs.
- Prepare and take ownership of compliance SOPs.
- Participate in investigation, root cause analysis, CAPA management and risk management activities as required.
- Keep work areas clean and free of hazards or dangerous conditions Follow all safety regulations, and promote positive safety behaviors, report unsafe work conditions and/or behaviors and maintain audit readiness.
- Execute internal audit (self-inspection) to assure compliance with global medical device and pharmaceutical regulations, local procedures, and corporate policies / procedures.
- Ensures compliance to audit schedule and timelines as per procedures.
- Cooperate and support coworkers to enhance overall capability of the organization.
- Participate in problem solving and troubleshooting of issues.
Key Requirements/Minimum 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 hours: M-F, standard
- Travel Requirements: none
- Relocation assistance: no
- Sponsorship available: no
#LI-DNI
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
