Brian Balcom Email & Phone Number

New York

Tasks include: Compliance Lead for the Packing Focus Factory management team. I perform duties to provide first-line Quality Assurance support to all aspects of the Packaging operation. I currently have three individuals directly reporting to me. I develop, implement and supervise teams and programs involving corrective and preventive actions (CAPA), procedural updates through a formalized document change system (Change Control), and quality deviation/event investigations within the Packaging… Show more Tasks include: Compliance Lead for the Packing Focus Factory management team. I perform duties to provide first-line Quality Assurance support to all aspects of the Packaging operation. I currently have three individuals directly reporting to me. I develop, implement and supervise teams and programs involving corrective and preventive actions (CAPA), procedural updates through a formalized document change system (Change Control), and quality deviation/event investigations within the Packaging Department. I currently perform all functional reviews for Investigation Reports, Production Forms, Manufacturing instructions, Standard Operational Procedure updates, and Change Controls for the Packaging department. I develop and implement new quality programs to ensure daily operations remain in compliance with regulatory updates. I participate in internal audits and assist with onsite requirements during FDA/DEA inspections. I provide technical support to solve quality and production problems within the Packaging department. I am currently the lead for all in-depth Root Cause Analysis (RCA) in relation to potential product impact situations that encompass the Packaging department. I support/participate in all new equipment installation projects as a SME lead, I am currently the backup Compliance lead in support of the Manufacturing Focus Factory. Show less

New York

Tasks include: Facilitator of the site CAPA program. Participate in the initiation, review, and closure of all site CAPAs. Facilitate all CAPA meeting and complete site weekly CAPA trending/tracking reports. I complete the review and approval of quality deviation/event investigations, in conjunction with the identification of proper CAPA actions as a result from these investigations. Present investigation and product disposition to Material Review Board and provide recommendation for final… Show more Tasks include: Facilitator of the site CAPA program. Participate in the initiation, review, and closure of all site CAPAs. Facilitate all CAPA meeting and complete site weekly CAPA trending/tracking reports. I complete the review and approval of quality deviation/event investigations, in conjunction with the identification of proper CAPA actions as a result from these investigations. Present investigation and product disposition to Material Review Board and provide recommendation for final product disposition. Complete Risk Assessments and Root Cause Analysis (RCAs) as needed. Support to the Change Control system, Annual Product Review, Annual Product Risk Assessment and Internal Audit Program. Participate in internal audits along with direct support during FDA inspections. Provided technical support to solve quality problems in the Packaging and Manufacturing departments. Participate as the backup Quality lead for the Packaging Focus Factory. Show less

Hobart New York

Tasks include: Ensuring that quality procedures are followed and evaluate the organization's products, materials, and facilities for compliance on shift. Determine if current methods and techniques result in meeting reliability standards or require modification. Ensure sustained adherence to multiple regulatory agency requirements during daily pharmaceutical manufacturing and packaging operations Perform audits of systems and triages of product related events to evaluate and contain impact… Show more Tasks include: Ensuring that quality procedures are followed and evaluate the organization's products, materials, and facilities for compliance on shift. Determine if current methods and techniques result in meeting reliability standards or require modification. Ensure sustained adherence to multiple regulatory agency requirements during daily pharmaceutical manufacturing and packaging operations Perform audits of systems and triages of product related events to evaluate and contain impact. Perform product inspections including tightened AQL for product defects. Assign daily responsibilities for the Quality Operations group. Conduct, document, and present detailed quality investigations to the site leadership team. Perform duties to provide first-line Quality Assurance support to all aspects of the packaging/production operations. Investigate and or close out quality event investigations as needed. Participate in Annual Product Reviews along with attending weekly Service Strategy meetings. Attend Production meetings and be able to update as to the status of ongoing quality issues and investigations. Show less

New York