Sr. QCD Technical Specialist

ROLE SUMMARY

The Senior Technical Specialist is a key technical role responsible for ensuring consistently high performance of testing equipment and processes.  The role requires strong focus on driving quality into testing processes, implementation of best practices and continuous improvement.  The Senior Technical Specialist will provide focused technical ownership expertise to ensure high quality and efficient sterile injectable products.  As technical lead, the Senior Technical Specialist partners with supervision and Quality Control Device (QCD) Lab colleagues to identify and implement innovative solutions.  Additional duties include project management, six sigma methods and training coordination.

ROLE RESPONSIBILITIES

• Effectively manage and coordinate QCD Lab technical projects and functions at the site in support of technical projects.
• Partner with Production, Quality Assurance (QA), Operational Excellence (OPEX) and other internal experts to develop quality investigations, assign root cause and identify/implement CAPA solutions.
• Collaborate and provide technical guidance related to technical or product investigations.
• As an individual contributor, represent the QCD Lab on assigned project teams to ensure completion of key project initiatives.
• Act as internal technical training resource for the QCD Lab.
• Work with Quality Operations and Regulatory Affairs to ensure regulatory filings are completed on time and to the appropriate standard.
• Champion process change proposals/requests as it relates to technical support operations.
• Anticipate potential problems, risks and technical conflicts and develop necessary contingency plans that optimize business continuity. 
• Ensure work activities are conducted in strict accordance with safety guidelines and process standards, such as FDA current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs)>

QUALIFICATIONS

Education/Background:

• Bachelor’s Degree (or higher) in Chemical Engineering, Mechanical Engineer, Electrical Engineering or a Science-related field.
• Ability to clearly present technical information and effectively communicate within all levels of the organization.
• Demonstrated ability to contribute to and lead project teams.
• Clear thinker: simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information and communicating priorities clearly and concisely.

Experience:

• Four (4+) years’ experience in pharmaceutical manufacturing with background in Manufacturing or Quality. 
• Previous aseptic manufacturing experience preferred.

Technical Skills:

• Must be able to apply solid reasoning skills to an investigation and to project planning.
• Must be self-motivated and flexible to learn and respond to changing responsibilities and priorities.
• Demonstrated commitment to values-based leadership and achieving objectives in a manner that is consistent with Kindeva Drug Delivery leadership behaviors.
• Demonstrated ability to interact effectively with all levels of the organization.
• Strong oral and written communication skills required.
• Six-Sigma training and project management experience is preferred.
• Strong commitment to product quality, continuous improvement and certified green belt with working knowledge or Right First Time (RFT) principles.