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Senior Quality Assurance Specialist

Your Role
The Senior Quality Assurance (QA) Specialist is responsible for day-to-day administration of Quality Assurance programs in support of the company’s Quality Management System. The Sr. QA Specialist will be involved in the development, implementation, and maintenance of Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820, ISO 13485), and other applicable quality and regulatory standards. Works with relevant departments to ensure successful implementation of quality systems and communicates the impact of changes to areas affected to ensure that the changes are integrated into day to day operations.

 

Responsibilities:

  • Ensure compliance to design change procedures, corporate policies and global regulations (FDA QSR, ISO, etc.) and make decisions/provide guidance to prevent a deviation or non-conformance.
  • Observe opportunities for potential risk in established instrument designs and manufacturing processes and implement corrective action as necessary. Identify opportunities for improvement of policies, procedures and methods; collaborate with stakeholders to streamline processes.
  • Effective interaction with development, technical operations and manufacturing staff to ensure quality, strive minimize the costs of reworking or waste and maximize customer satisfaction with the products.
  • Perform the review and release of Design History Files (DHF). Work with R&D and Regulatory Affairs to ensure that DHF are complete and compliant.
  • Perform routine QA responsibilities which include reviewing Device History Records (DHR) for finished goods release.
  • Support Quality System audit activities including internal audits, supplier audits, and regulatory body audits.
  • Prepare quality reports, data, and key performance indicators (KPI) for management reviews.
  • Assist with other duties which include CAPA and NCR investigations. This includes ensuring proper handling, quarantine and disposition of non-conforming material.
  • Identify top issues and recommend CAPAs/SCARs and drive to closure where required.
  • Analyze statistical data to evaluate trends, investigate failures completely to determine the root cause and take appropriate corrective action to prevent recurrence.
  • Establish and drive to daily management actions for quality processes that support corporate quality objectives.
  • Identifies quality improvement in areas of responsibility.
  • Other such duties as determined by QA Supervisor or Quality Manager.

 

Who You Are

  • BS or MS in Chemistry/Biochemistry, Biology or related field
  • 5+ years of experience working in a regulated environment in Quality in the biotech industries.
  • Working knowledge with domestic and international Quality System Regulation (QSR) requirements for the In Vitro Diagnostic industry; e.g., 21CFR Part 820, ISO 13485:2016, and/or IVD Directive.
  • Must have excellent interpersonal skills, writing skills, and communication skills.
  • Good organizational skills and attention to detail.
  • Ability to work independently
  • Experience working in ISO 13485 and/or FDA regulated industry
  • Good computer skills, PC including MS Excel a must.
  • Knowledge of SAP and/or SAP NEXT preferred.

 

 

Job Requisition ID:  180444
Location:  Rocklin
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Biochemistry, Biotech, QA, Quality Assurance, Quality, Science, Technology

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