Paul Ziuko Email & Phone Number

United States

Tonawanda, New York, United States

• Routine SOP review and gap analysis to ensure compliance with cGMP, including authoring of SOPs• Validation Master Plan oversight and management of validations program including oversight of IQ/OQ/PQ and document drafting, review, and execution of IQ/OQ/PQ protocols for filling, packaging, facility, inspection and all other cGMP production equipment• Oversight and approval of facilities maintenance operations and work orders program• Change Control Request oversight, approval and management of CCR program• Hands on training of personnel• Customer and regulatory audit lead and support• Project Manager for new equipment purchases, onboarding and validation CAPA Building of Quality, Calibration and Preventative Maintenance programs

Tonawanda, Ny

Manage site validation programPerform site validation activities including IQ,OQ,PQ, RQ on all cGMP production equipment and processesDraft SOP's and Protocols to support all business activitiesManage projectsCoordinate outside vendors and contractorsEnsure site compliance with all cGMP, FDA and regulatory agencies including audit and inspection supportLead and direct QA Engineering team

Lockport, Ny

Provides daily QA leadership to Operations Facilitates and/or oversees the root cause / corrective action investigationprocess associated with internal, external and supplier related non-conformance's in compliance with Quality System procedures. This includes drafting customer responses as required. Performs appropriate QA follow-up and verification activities associated withCorrective and Preventive action plans that result from the variousNCR’s, SCAR’s, CAPAR’s, internal audits, customer audits, supplier audits and PQM’s.Reviews all Job Jacket (Batch Record) documentation Oversees Final QA Release activities Performs in-process Job documentation QA Release activities in support of Lean initiatives, which includes documented product sampling and assessment per defined acceptance criteria. Provides in-process Quality System support to manufacturing personnelregarding defect disposition and isolation, set-up of inspections, initiation ofsampling plans, quarantine of non-conforming materials, and completion ofapplicable documentation.Supports the QA and manufacturing value stream leadership by participatingin routine production meetings, DAM’s, DNR’s, SCAR review meetings,MRB’s, process improvement teams, validation teams, training events andLean events as required.Provides QA support as assigned to projects that support the strategicinitiatives of the company and the Quality department.Provides oversight of overall facility maintenance including the buildinginterior, exterior, and equipment. Utilizes mechanical inclination totroubleshoot issues and coordinates vendors to facilitate necessarymaintenance.Leads the process for updating and maintaining current operating proceduresand manages the writing and implementation of new operating procedures.Conducts internal staff training of Standard Operating Procedures and annualcGMP compliance training. Manages the safety program.

Tonawanda, Ny

• Directly supervise all Lab Personnel and production floor activities• Coordinate execution of daily production schedules and modifies as required • Direct the preparation and submission of regulatory, compliance agency applications, reports, or correspondence including oversight/maintenance of HAACP, FDA, OU Kosher, FSA and SQF policies and procedures; product trends and statistical analysis, Process Capablity• Lead product failure investigations. Review and approve site CAPA plans. Work with site personnel to ensure root cause analysis and CAPA’s are effective. Maintain site CAPA program.• Review and approve site change control documents. Work with site personnel to ensure changes are appropriately documented, executed and justified to comply with regulatory and customer requirements. • Actively assist QA team in all QA functions, including syrup testing, finished product testing, in-process line checks, appearance, odor, taste, brix, color, acidity and pH and make necessary adjustments when needed.• Daily maintenance of site treated water system; adding chemicals at defined intervals and in-process testing, assuring water quality is in within site specifications • Maintain and manage all batch records for all product produced• Monitor all package quality requirements such as container condition, label condition, Lot and Expiration coding, closure and seam/torque test.• Set-up, adjust and operate laboratory equipment and instruments such as density meter, spectrophotometer, pH meter, titrator, scales.• Calibrate lab instruments at required intervals and maintain Calibration database.• Perform micro-biological testing as required.• Procure, retain and manage all required retention samples for specified life cycle, maintain retention sample database.• Enforce all safety policies and procedures in compliance with all Site policies and local, state and federal safety regulatory agencies.

• Oversee all aspects of manufacturing for adherence to FDA, cGMP and Standard Operating Procedure (SOP) compliance• Manage staff of up to 15 MQA Specialists across 2 shifts• Conduct employee interviews, performance appraisals and disciplinary hearings• Review/Approval/Drafting of process deviations/investigations• Review/Approval/Drafting of CAPA’s (Corrective Action/Preventative Action)• Review/Approval/Drafting of Standard Operating Procedures• Review/Approval/Drafting of new product submissions • Review/Approval/Drafting of Installation, Operation, Performance and Investigation protocols• Review/Approval/Drafting of customer inquiries/complaints• Training of MQA staff and production personnel• Troubleshooting of Quality/Manufacturing process related issues• Technical reviewer of site documents, including validation and computer based system protocols• Controlled substance handler with DEA clearance• Member of 5S Team (Sort, Set in Place, Standardize, Shine, Sustain)• Represent the QA department in daily shift change meeting

• Drafting/Review/Execution of Installation, Operation, Performance and Investigational protocols for new and existing equipment• Drafting/Review/Execution of Standard Operating Procedures (SOP’s) for new and existing equipment• Execution and review of Validation protocols for computerized systems• Scheduling and performance of qualifications of existing equipment• Training of production personnel on SOP’s for new and existing equipment• Performance of off -site Factory Acceptance Testing (FAT) for new and existing equipment• Troubleshooting of new and existing equipment• Validation of sterilizers, ovens, tunnels, washers, and freeze dryers (lyophilizer)• Led team to validate 1st Freeze Dryer (lyophilizer) at Grand Island site, including Factory Acceptance Testing, writing of IQ,OQ and PQ, SOP’s and training

• Auditing of all manufacturing processes for adherence to SOP’s and FDA regulations• Data analysis to increase process yields• Maintenance of product reserve sample database