Senior Director QA/QC & Technical Services

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies.  We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

POSITION SUMMARY:
The Senior Director QA QC & Technical Services provides advanced technical and analytical support to Quality Assurance, Technical Services, and the Quality Control laboratory. This role ensures compliance with cGMP standards, regulatory requirements, root cause analysis, CAPA implementation and internal procedures while improving the efficiency, accuracy, and compliance of laboratory operations. Responsibilities include troubleshooting, analytical, and manufacturing processes, leading equipment validations and calibrations,
developing and validating chemical assays, mentoring junior staff, and supporting regulatory submissions and inspections.

ROLES & RESPONSIBILITIES:
• Perform technical duties in specialized area or function as leader in absence of management, as assigned. Assist laboratory supervisors with tasks, as needed.
• Perform efficient and reliable analytical tests following validated procedures for a wide variety of methods and sample types as assigned.
• Document all results in accordance with cGMPs and written procedures.
• Trouble-shoot and solve problems with assays and equipment with little or no supervision. Report all observations.
• Recommend changes to methods and operations as appropriate.
• Interpret analytical results correctly, notifying Management promptly of both situations that indicate analytical issues and manufacturing or product issues.
• Develop/implement appropriate corrective and preventative actions (CAPA)
• Lead and write lab investigations and support manufacturing plant investigations by established procedures and in accordance to FDA regulations.
• Maintain the QC laboratories to comply with cGMP and USAntibiotics standards of safety, quality, and cleanliness.
• Participate in analytical method validations or transfers as required.
• Perform satisfactorily on all analyst qualification studies, indicating technical proficiency.

• Plan, perform, and document non-routine tests (or special studies) and investigations under the direction of Manager/Director.
• Collaborate within and abreast to QA, QC, and Technical Services teams to ensure timely and compliant support to manufacturing.
• Participate in cross-functional projects, investigations, and improvement initiatives.
• Act as technical liaison during interactions with vendors, regulatory inspectors and internal teams.
• Evaluate and utilize state-of-the-art equipment including automated systems and computerized systems to perform testing and meet the goal of improved assay performance, including reliability , cost and assay characteristics.
• Maintain and improve proficiency of operations through training.
• Write validation reports, analytical procedure SOPs and equipment SOPs as required.
• Notify Management of any SOPs that may require revision and initiate change requests per written policy, providing sufficient evidence/documentation to support change request.
• Conduct special studies in accordance with protocols and direction of management. Prepare well documented reports of results.
• Carry out other departmental duties as deemed appropriate by the respective Manager/Director.
• Broaden understanding of subtleties of the techniques utilized by keeping current with technical and professional literature, attending technical discussions both inside and outside the USAntibiotics community.
• Provide technical and professional expertise to less experi