Job Opportunities 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.

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Job description

The QA Specialist – Supplier Management will be a strong partner to the Global Quality and Regulatory function, as well as across the various Sequencing Solutions functions.

• Assures local and partner Quality Management Systems (QMS) compliance with International Standards Organization (ISO) regulations. Provides direction to local and partner management to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards.
• Interacts across organizations, levels, and groups to accomplish job functions. Participates in cross-functional meetings with Divisional teams and other Sequencing sites for integration and improvement of processes and systems.
• Responsible for management of suppliers, including creation and maintenance of policies and procedures, supplier qualification and evaluation, identification of and training for primary stakeholders, and preparation for, execution of, and responding to Health Authority, Notified Body, and Partner inspections.
• Responsible for the Supplier Inspection Management program, including creation and maintenance of procedures, generation of annual supplier audit plans and schedules, support and execution of global supplier audits, supplier corrective action/ preventative action (SCAR) management, metrics management, and collaboration with other functions involved in the global supplier audit program.
• Participates as necessary in internal, external, and supplier auditing programs and conducts evaluations to ensure compliance with Federal, State, and local regulations pertaining to ISO, and associated Regulatory agencies.
• Expected to operate independently, holding him/her accountable to proactively fulfil tasks and achieve results within assigned timelines.
• Expected to understand strategic priorities developed by upper management and to respond to requests with appropriate urgency and with an organized approach.

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.
• 5+ years of relevant medical diagnostic/device industry/regulated pharma or biotechnology experience, including experience conducting GMP and ISO audits.
• Audit experience in medical device/pharmaceutical company preferred. ·
• ISO13485 Lead Auditor training and certificate required.·
• Thorough working knowledge of relevant international ISO Standards (9001, 13485, 14971) and regulations (European medical devices directives, 21 CFR - part 820) would be advantageous.
• Required to travel 1-2 times per year.

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.

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Job description

The QA Specialist – Internal Audits will be a strong partner to the Global Quality and Regulatory function, as well as across the various Sequencing Solutions functions.

• Assures local and partner Quality Management Systems (QMS) compliance with International Standards Organization (ISO) regulations. Provides direction to local and partner management to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards.
• Interacts across organizations, levels, and groups to accomplish job functions. Participates in cross-functional meetings with Divisional teams and other Sequencing sites for integration and improvement of processes and systems.
• Responsible for management of the Site Internal Audit program, including creation and maintenance of policies and procedures, generation of annual audit plans and schedules, execution of internal audits, internal audit corrective action/ preventative action (CAPA) management, mentoring and training for audit participants, auditor qualification, metrics management, and collaboration with other functions involved in the internal audit program.
• Responsible for the Inspection Management program, including creation and maintenance of procedures, identification of and training for primary stakeholders, and preparation for, execution of, and responding to Health Authority, Notified Body, and Partner inspections.
• Participates as necessary in internal, external, and supplier auditing programs and conducts evaluations to ensure compliance with Federal, State, and local regulations pertaining to ISO, and associated Regulatory agencies.
• Expected to operate independently, holding him/herself accountable to proactively fulfil tasks and achieve results within assigned timelines.
• Expected to understand strategic priorities developed by upper management and to respond to requests with appropriate urgency and with an organized approach.

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.
• 5+ years of relevant medical diagnostic/device industry/regulated pharma or biotechnology experience, including experience conducting GMP and ISO audits.
• Audit experience in medical device/pharmaceutical company preferred.
• ISO13485 Lead Auditor training and certificate required.
• Thorough working knowledge of relevant international ISO Standards (9001, 13485, 14971) and regulations (European medical devices directives, 21 CFR - part 820) 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