KEY JOB FUNCTIONS
- Develop, edit, review, and approve validation protocols and reports.
- Plan, implement, communicate, and maintain quality programs in compliance with ISO, cGMP, and industry standards.
- Set quality assurance objectives for review and approval by Top Management.
- Manage internal ISO audit process and oversee corrective actions.
- Manage ISO document control process, including review and approval of SOPs.
- Participate in new product development for quality assurance.
- Design and implement an effective CAPA process with the Quality team.
- Establish and maintain supplier approval and audit process with Procurement.
- Manage sterile validation process for manufactured products.
- Understand global regulations affecting product lines and ensure compliance.
- Manage company's change control process.
- Work with Marketing to review and update product technical information.
- Establish targets for quality improvement efforts and track results.
- Design and implement quality training programs.
DESCRIPTION OF CANDIDATE
- Demonstrate integrity and professionalism.
- Maintain a positive attitude in the face of challenges.
- Maintain a professional demeanor internally and externally.
- Maintain high attention to detail for compliance.
- Ability to work independently and in a team.
- React with urgency to production and customer needs.
- Communicate effectively with all levels of the organization.
QUALIFICATIONS OF CANDIDATE
- Bachelor’s degree or higher in science or engineering.
- Ten years experience in manufacturing, including five + years in quality management.
- Solid understanding of sterility validation and guidelines.
- Strong knowledge of FDA, cGMP, and ISO requirements.
- Excellent written communication skills.
- Ability to prepare and present information effectively.
- Ability to use judgment in problem analysis and decision-making.
- Excellent computer aptitude and knowledge of Microsoft Office and ERP systems.
DESIRABLE SKILLS / EXPERIENCE
- Textile industry experience.
- Pharmaceutical or medical device industry experience.
- Lean / Six Sigma knowledge and experience.
- Previous experience with ISO 9001, ISO 14001, and ISO 17025 systems.
- Previous experience with LIMS systems.
- Previous experience with EPA or BPR regulations for disinfectant products.
PHYSICAL REQUIREMENTS
- Use testing equipment and operate computer.
- Stand, walk, sit, reach, lift up to 25 lbs.
- Climb, balance, stoop, crouch, crawl, smell.
- Close, peripheral, and depth perception vision.
- Work in a normal office environment.
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