Senior QA Specialist- Operations Quality at Kapa Biosystems

Job description

The Quality Specialist – Operations Quality, Sequencing will be a strong partner to the Global Quality and Regulatory function, as well as across the various Sequencing Unit functions.

• Responsible for supporting management in developing and implementing Quality Management System (QMS) elements and supporting infrastructure/tools in compliance with International Standards Organization (ISO) regulations, and Roche corporate requirements.
• Able to analyse QMS elements/processes and derive procedures to drive compliant implementation. Supports Roche Sequencing Unit quality, operations and supply chain departments and efficiency initiatives by providing technical support across organizations, levels, and groups.
• Functions as project team leader or internal consultant for identification, execution, and implementation of CAPAs, NCRs, Validations and process improvement activities, as appropriate.
• Leads the development and distribution of key performance indicators (KPIs) in alignment with Quality Objectives. Utilizes Quality Engineering tools and services provided through project work or training such as: Experimental study design (DOE); Sampling plans (acceptance sampling and experimental sampling); Failure investigation data analysis (e.g. ANOVA, F&T testing, basic data charting).
• Participates in internal, external, supplier, and shop floor auditing programs as appropriate.
• Assures local organization is trained in the use of Quality tools in support of process improvement initiatives. Facilitates risk analysis activities (e.g., FMEA).
• Discusses and supports resolution of Validation deviations. Performs Validation/Qualification document review and approval, ensuring compliance with GMP, ISO, IVDD, and Roche guidelines and requirements.
• Expected to operate independently, holding him/her accountable to proactively fulfil tasks and achieve results within assigned timelines.

Qualifications and Education Requirements

• Bachelors’ degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience. Master’s degree or equivalent would be preferred.
• Statistical training, Lead Auditor training and/or Six Sigma Green/Black Belt would be advantageous.
• 5-8 years of relevant medical diagnostic/device industry/regulated pharmaceutical or biotechnology experience, including minimum of 5 years of direct Quality Engineering or Quality Operations. Experience focused on quality systems, regulatory affairs/compliance, project management, controlled documentation, or change control.
• Thorough working knowledge of relevant international ISO Standards (13485, 14971) and regulations (European medical devices directives) would be advantageous.

Preferred Skills

• Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients.
• Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment.
• Track record of providing sound Q&R judgment/ideas and business partnering.
• Strong leadership/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations (medical, scientific, and manufacturing).
• Strong communication skills with both internal and external customers, with ability to get points across clearly and simply.