Safetec of America, Inc. has been your trusted source for infection control, first aid, and compliance products for over 30 years. We are a local, family-owned, OTC pharmaceutical manufacturing company with a reputation for retaining employees because we treat them like family. 

We are always looking for talented people to join our team. If you have the ambition and drive to take on new challenges as the next step in your career, apply today!

Responsibilities:

• Quality System Leadership: Develop, implement, and monitor Quality Control programs, SOPs, and Key Performance Metrics aligned with internal procedures and regulatory requirements.
• Testing and Validation: Oversee raw material, in-process, finished goods, and stability testing, ensuring analytical methods are validated and qualified. Ensure the review/approval of raw materials/components, stability studies, and finished goods is performed per cGMP/GLPs. 
• Team Management: Lead and mentor QC staff; manage schedules, performance, and skill development. Facilitate cross-functional communication and ensure all testing, metrics, projects and departmental goals are achieved.
• Compliance and Audits: Ensure adherence to regulatory requirements; lead internal/external audits, root cause investigations and corrective/preventive actions.
• Problem Solving: Support the completion of laboratory investigations and ensure implementation of corrective and preventative actions relating to OOS/OOT investigations, customer complaints and QC activities, as appropriate.
• Continuous Improvement: Drive quality initiatives, lean processes and process optimization. 

Qualifications:

• Education: Bachelor’s degree in chemistry, Microbiology, or another related scientific field required.
• Experience: 8+ years experience in a Quality Control laboratory environment, with at least 6 years of leadership experience. Experience in OTC pharmaceutical manufacturing or a regulated manufacturing environment preferred.
• Technical Knowledge: Strong knowledge of analytical chemistry, laboratory testing methods, method validation, stability programs, laboratory instrumentation, and troubleshooting.
• Regulatory Knowledge: Thorough understanding of FDA regulations, cGMPs, USP requirements, GLP principles and applicable quality standards.
• Quality Systems: Experience managing laboratory quality systems, investigations, deviations, CAPAs, change controls and data integrity requirements.
• Leadership: Demonstrated ability to lead, develop and mentor technical personnel, manage departmental priorities and drive accountability.
• Analytical Skills: Strong problem-solving, statistical analysis, data interpretation and decision-making skills.
• Communication: Excellent written and verbal communication skills with the ability to collaborate effectively across Quality Assurance, Manufacturing, Regulatory and other departments.
• Organization: Ability to manage multiple priorities, projects and deadlines while maintaining accuracy and attention to detail.