Senior Specialist, Operations Support, 1st Shift

Role Summary

The Senior Specialist, Operations Support provides leadership and hands-on support for documentation, change control, investigations, and continuous improvement initiatives within manufacturing and packaging operations. This role supports product transfers, operational readiness for new products, and training within the Mfg/Pkg Operations Department, focusing on standardized work practices, data analysis, and quality culture.

Responsibilities

• Provides leadership and support for authoring/reviewing documents related to standardized work practices and operational requirements for the cleaning, running and set-up of Mfg/Pkg lines (ie SOPs, Work Instructions, BPRs, protocols, training documentation, etc).
• Provide support in authoring and leading change control related projects for existing equipment and processes. Assures coordination of efforts and adequate documentation is provided for timely closure of change controls.
• Facilitates and leads investigational activities to determine root cause and appropriate corrective/preventive actions.
• Performs routine process monitoring, document review and trending of previous events to identify opportunities for continued improvement.
• Collects, analyzes, and interprets data from production systems and processes. Recommends action plans for process improvements where appropriate.
• Authors reports and project plans to support departmental projects and initiatives.
• Participates/leads projects and CAPA related to Right First Time initiatives and continuous improvements.
• Functions as a department representative and liaison for product transfers, supporting operational readiness for commercialization of new products.
• Supports manufacturing and packaging in inspection readiness and quality culture related projects/initiatives by performing management directed evaluations and self-inspection activities.
• Provides leadership and support for employee training and development, within the Mfg/Pkg Operations Department.
• Perform other duties as assigned.

Qualifications

• Required: Minimum of a Bachelor's Degree (or equivalent) and 2 years of related experience. A combination of experience and/or education will be taken into consideration.
• Required: Working knowledge and understanding of 21 CFR parts 11, 210, 211 and 820; ability to apply that knowledge with sound judgment in position-appropriate decision making; understanding of manufacturing and packaging processes, equipment functionality, inspection systems; knowledge of document control, training, investigations and CAPA; functional understanding of statistical methods for product quality and structured problem-solving methods.
• Required: Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
• Required: Strong interpersonal and communication skills; excellent problem-solving abilities; ability to lead conflict resolution; professionalism with sensitive information; excellent time management; highly organized; team player; technical writing skills; proficiency with Microsoft Office, Minitab, TrackWise, D2 (Author experience), Document Change Control Systems; ability to learn new computer-based systems.

Skills

• Proficiency in data analysis and interpretation; ability to translate data into action plans.
• Technical writing and documentation management.
• Familiarity with manufacturing and packaging systems and change control processes.
• Problem-solving and CAPA execution related to quality and efficiency improvements.

Education

• Bachelor’s Degree or equivalent.