Sigma
Senior Quality Assurance Associate
The Senior Quality Assurance Associate provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a Senior QA Associate, you are responsible for the coordination and maintenance of Quality Systems (i.e., Document Control, Record Control, Training Program Maintenance, Deviation/CAPA, Complaints, Change Control) and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program. Responsibilities: Improve and maintain quality systems in ISO production environments, ensuring compliance with Life Science and site quality policies. Manage the electronic documentation system, which includes writing, reviewing, and approving controlled documents such as Standard Operating Procedures (SOPs), Specifications, and Master Manufacturing & Packaging Procedures. Oversee training management, including metric reporting and managing the electronic training platform, to meet departmental goals. Assist and/or act as a Lead Auditor in conducting internal audits to ensure compliance with quality policies. Support the department's key performance indicators (KPIs) by ensuring the timely completion of Corrective and Preventive Actions (CAPAs), Deviations, Complaints, and Change Controls. Assist in the investigation of customer complaints and contribute to Root Cause Investigations and Effectiveness Checks for nonconforming incidents. Regularly communicate with coworkers and interact with other departments to support overall quality objectives. Conduct specific Quality System Training relevant to various job functions. Physical Requirements: 70% - 90% Office Environment, 10% - 30% Production, QC, Packaging. Who You Are: Minimum Qualifications: Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 2+ years of experience working in the life science industry. OR Associate's Degree and 5+ years working experience in a Quality Assurance role. OR Bachelor's Degree in any discipline and 5+ years working in a Quality Assurance role. Preferred Qualifications: Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment. Current fine chemical industry knowledge &/or experience desired. Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.) Good communication (verbal & written) and customer services skills. Good writing skills and experience writing procedures & report. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. Capacity for independent work. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
The Senior Quality Assurance Associate provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a Senior QA Associate, you are responsible for the coordination and maintenance of Quality Systems (i.e., Document Control, Record Control, Training Program Maintenance, Deviation/CAPA, Complaints, Change Control) and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program. Responsibilities: Improve and maintain quality systems in ISO production environments, ensuring compliance with Life Science and site quality policies. Manage the electronic documentation system, which includes writing, reviewing, and approving controlled documents such as Standard Operating Procedures (SOPs), Specifications, and Master Manufacturing & Packaging Procedures. Oversee training management, including metric reporting and managing the electronic training platform, to meet departmental goals. Assist and/or act as a Lead Auditor in conducting internal audits to ensure compliance with quality policies. Support the department's key performance indicators (KPIs) by ensuring the timely completion of Corrective and Preventive Actions (CAPAs), Deviations, Complaints, and Change Controls. Assist in the investigation of customer complaints and contribute to Root Cause Investigations and Effectiveness Checks for nonconforming incidents. Regularly communicate with coworkers and interact with other departments to support overall quality objectives. Conduct specific Quality System Training relevant to various job functions. Physical Requirements: 70% - 90% Office Environment, 10% - 30% Production, QC, Packaging. Who You Are: Minimum Qualifications: Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 2+ years of experience working in the life science industry. OR Associate's Degree and 5+ years working experience in a Quality Assurance role. OR Bachelor's Degree in any discipline and 5+ years working in a Quality Assurance role. Preferred Qualifications: Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment. Current fine chemical industry knowledge &/or experience desired. Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.) Good communication (verbal & written) and customer services skills. Good writing skills and experience writing procedures & report. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. Capacity for independent work. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.