Jobs for People with MS: National MS Society

Scope of Work:Responsibilities will include to provide support to a 24/7 manufacturing operations, maintain Quality Systems, Compliance, and Good Manufacturing Practices (GMP) compliance. The Principal Associate for Quality Assurance provides proficient assistance and guidance in deviation investigations, analytical investigations, change control proposals, procedures and master formula revisions, process and equipment qualification, validation, and batch disposition.Main Responsibilities•Support presential production floor operations•Experience in the evaluation batch production records and performing batch disposition.•Review and approve investigations, as appropriate, assuring robustness of Root Cause Analysis and effectiveness of CAPA’s.•Strong knowledge and technical expertise in data integrity management and quality systems•Ability to effectively write, review and/or approve technical and quality documents to ensure quality attributes are met•Recognized understanding of regulations (BLA CFR 600 series prefer)•Experience and participation in Regulatory inspections•Demonstrate proficiency in Cleaning Processes, Cleaning Validation, Process Qualification, Equipment Qualification, Process Validation, Contamination Control, Environmental Control of Clean Rooms, Method Validation.•Demonstrate proficiency in Risk Assessment and FMEAs.•Active participation in Gemba Walks, manufacturing rooms inspections, and practice matches procedure on the production floor.•Serve as a liaison between the Process Team and other Quality areas (Labs, Compliance, Incoming, Engineering, Automation, TS/MS, Utilities, etc.)•Demonstrate proficiency to interpret and apply standards to different scenarios.Basic Requirements•Minimum of Bachelor of Science preferable in Chemical Engineering, Biochemistry, Biotechnology. Most preferable a Licensed Doctor of Pharmacy (Pharm D).•At least seven (7) years of experience in Quality Assurance supporting Manufacturing, Compliance/Audit, Quality Systems, QA for Quality Control, and/or Technical Services/Manufacturing Science.Other Skills & Preferences•Demonstrate teamwork by collaborating cross functionally with various levels of the organization•Communication skills with personnel at different organizational levels.•Organize and prioritize multi-functional tasks.•Attention to details and ability to identify improvement opportunities or discrepancies.•Work well and make logical decisions under fast-paced work environment.•Exercise good judgment and be assertive when required.•Work under minimal supervision•Demonstrated decision-making, problem-solving, organizational, and critical thinking techniques.•Ability to share knowledge and train others.•Strong compliance mindset.Availability•Availability to provide support to a 24/7 manufacturing operations•Work as a resource in other strategic areas of Quality Assurance, QA for Quality Control, Compliance based on business needs.•Availability and flexibility to work extended hours when required.•Work and provide support during irregular hours, shifts rotation, weekends, and holidays, when required.Knowledge•Knowledge on pharmaceutical / biotechnology operations and its related sciences.•Managing multiple project objectives.•Technical Writing.•Root Cause Tools•Current Good Manufacturing Practices (cGMPs).•Personal computer literate.•Fully Bilingual (English and Spanish) Strong written and verbal communication skills.