Sigma
Quality Assurance Specialist
The Quality Assurance Specialist provides compliance oversight across the St. Louis ISCO MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems 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 both ISO and non-GMP production environments, ensuring compliance with Life Science and site quality policies. Drive quality improvement across multiple departments by completing a high volume of work to meet department goals. Communicate effectively with coworkers, other departments, and management, bringing critical deviations and operational statuses to their attention. Perform internal and external audits, representing the site during customer and regulatory inspections. Contribute to investigations of customer complaints, nonconforming incidents, and effectiveness checks. Assist in maintaining department KPIs by ensuring the timely completion of CAPAs, Deviations, Complaints, and Change Controls. Manage documentation control activities, including the electronic documentation system, and write, review, or approve various controlled documents like SOPs and master manufacturing procedures. Conduct quality system training for staff to ensure adherence to quality guidelines and accurate work. Qualifications: Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc). 3+ years' experience in a QA job function. OR Bachelor's Degree in any discipline. 5+ years Quality System (i.e., ISO environment) experience in the specific QA job function. Preferred Qualifications: Master degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering. Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, EXCiPACT, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment. Current fine chemical industry knowledge &/or experience. 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.). Excellent communication (verbal & written) and customer services skills. Good writing skills and experience writing technical documentation & reports. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. 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 Quality Assurance Specialist provides compliance oversight across the St. Louis ISCO MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems 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 both ISO and non-GMP production environments, ensuring compliance with Life Science and site quality policies. Drive quality improvement across multiple departments by completing a high volume of work to meet department goals. Communicate effectively with coworkers, other departments, and management, bringing critical deviations and operational statuses to their attention. Perform internal and external audits, representing the site during customer and regulatory inspections. Contribute to investigations of customer complaints, nonconforming incidents, and effectiveness checks. Assist in maintaining department KPIs by ensuring the timely completion of CAPAs, Deviations, Complaints, and Change Controls. Manage documentation control activities, including the electronic documentation system, and write, review, or approve various controlled documents like SOPs and master manufacturing procedures. Conduct quality system training for staff to ensure adherence to quality guidelines and accurate work. Qualifications: Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc). 3+ years' experience in a QA job function. OR Bachelor's Degree in any discipline. 5+ years Quality System (i.e., ISO environment) experience in the specific QA job function. Preferred Qualifications: Master degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering. Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, EXCiPACT, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment. Current fine chemical industry knowledge &/or experience. 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.). Excellent communication (verbal & written) and customer services skills. Good writing skills and experience writing technical documentation & reports. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. 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.