Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Manager, Packaging
Piramal Critical Care
04.2022 - Current
Responsible for delivering high quality product generating in ~ 280mm annually
Reduction in quality events by 7% from previous year
Increased throughput by 14% from previous year
Instituted a tier management approach
Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
Oversee production activities to assure performance to plan is achieved
Forecasts and sets goals and objectives, identifies, and allocates resources as needed
Manages front line supervisors in completion of daily operational tasks and assignments
Manages off-shift staff in execution of daily work; assures operators comply with validated parameters and standard operating procedures, cGMP regulations and safety requirements; provides constructive operator feedback
Counsels, trains, & develops front line supervisors for efficient performance and assists in their career development; creates an atmosphere of team effort & open communication
Provides weekly reports to upper management addressing key accomplishments, issues and drives improvement opportunities
Supports regulatory inspections such as DEA and FDA audits
Drives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure
Reviews documentation such as batch records and logs to assure accurate recording of processes in conformance to policies and procedures and in compliance with Good Documentation Practices
Develops training programs & assures training is conducted
Reports & initiates production schedule changes, requests equipment and facility repairs, or modifications
Controlled costs to keep business operating within budget and increase profits.
Head of Operations
Sharp Packaging Solutions
04.2017 - 04.2022
Responsible for the largest revenue generating business unit ~125mm, Deliver reliable supply, cost savings, and high product quality through successful influence and relationship management of the business
Reduced operational risks while organizing data to forecast performance trends.
Interface with key internal stakeholders in Source, Plan, Quality, and business strategy to define the business model
Drive for simplification and harmonization across department processes by leading a team to update all departmental communications visual KPI boards to easily identify performance on safety, quality, delivery, and production performance
Instituted a tier management approach.
Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills.
Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
Interacted well with customers to build connections and nurture relationships.
Global Operations Manager
Sharp Packaging Solutions
01.2012 - 04.2017
Tasked to transition cultures at our European facilities traveled back and forth over a five-year period, identify opportunities, make recommendations regarding continuing operations
Continuous improvement mindset, seeking out opportunities to increase revenue by driving operational efficiencies
Partner with business development in both US and our sites in Europe to ensure continued growth and ongoing satisfaction of strategic client relationships.
Collaborated with cross-functional teams to align operations with corporate objectives.
Led weekly meetings with regional staff to review progress, address challenges and drive timely task completion.
Spearheaded operational procedures and processes to improve efficiency and optimize operations.
Enforced compliance with local, state and federal regulations and company standards.
Pharmaceutical Manufacturing Supervisor
Corepharma
01.2011 - 01.2012
Supervise the day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities – to meet customer requirements including deadlines and quality standards
Provide manufacturing input into integration and validation of new equipment and processes
Review, approve, and manage documentation for batch and system records
Implement changes as needed based on performance and productivity assessments.
Completed production plans by scheduling and assigning personnel to daily tasks.
Pharmaceutical Manufacturing Supervisor
Sharp Packaging Solutions
01.2004 - 01.2011
Supervision and oversight of secondary packaging of tablets, capsules, and powders, bottles, blisters, and pouches
Managed the biotechnology COE business unit, focused on Time out of refrigeration (TOR)
Staffed and trained sixty to eighty regular full-time, and temporary line associates
Prioritized daily repairs; assigned daily work assignments and collaborated cross-functionally with quality and technical operations to maintain the highest level of product integrity
Coordinated all validation activities for the COE
Developed and implemented downtime log to identify cost trending associated with equipment downtime
Adhere to all FDA regulations and specifications.
Communicated job expectations and monitored employees.
Performed accident investigations.
Troubleshot equipment to reduce service calls and downtime.
Quality Assurance Supervisor and Production Supervisor
B.Braun Group
01.1992 - 01.2004
Held positions of increasing leadership responsibility in quality assurance and operations during twelve years of tenure
Promoted adherence to quality standards by educating personnel on quality control.
Staffed, trained, and supervised up to seventeen QA associates
Ensured compliance to protocols, regulations, SOPs, WRKIs, and cGMPs
Analyzed quality and performance data to support operational decision-making.
Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
Staffing and oversight of up to forty employees ranging from QA inspectors, mechanics, machine operators, and material handlers in a medical device manufacturing facility
Managed Injection molding and extrusion departments
Prioritized daily repairs, delegating daily assignments along with interfacing with all levels of management and support groups
Was Instrumental in facilitating the start-up and continued operation of the Quality Assurance department in a new plant
Coach (Volunteer) youth sports programs, football, wrestling and Baseball
Golf
DIY Property rehab
Certification
Lean Manufacturing Six Sigma Green Belt Training
Timeline
Manager, Packaging
Piramal Critical Care
04.2022 - Current
Head of Operations
Sharp Packaging Solutions
04.2017 - 04.2022
Global Operations Manager
Sharp Packaging Solutions
01.2012 - 04.2017
Pharmaceutical Manufacturing Supervisor
Corepharma
01.2011 - 01.2012
Pharmaceutical Manufacturing Supervisor
Sharp Packaging Solutions
01.2004 - 01.2011
Quality Assurance Supervisor and Production Supervisor
B.Braun Group
01.1992 - 01.2004
A.A. General Studies -
Northampton Community College
Lean Manufacturing Six Sigma Green Belt Training
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Cheryl R. Skasko-ShemansikCheryl R. Skasko-Shemansik
Learning & Training Manager at Piramal Pharma Solutions & Piramal Critical CareLearning & Training Manager at Piramal Pharma Solutions & Piramal Critical Care