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Sr. QA Specialist

Location: 

CA-Emeryville, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  172587

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

The Sr QA Compliance Specialist manages their own activities related to their area of expertise.  They may also schedule and oversee (but not formally evaluate) the work of others related to their area of expertise.

Key point of contact to ensure compliance with and demonstrate knowledge of site level policies and regulatory guidance. Provides significant guidance to others regarding their area of expertise.

 

Position Responsibilities:

The specific duties/responsibilities include, but are not limited to:

  • Independently performs moderately complex tasks in support of their area of expertise.
  • Ensures governing documents for their area of expertise are in accordance with HA regulations and company policies/standards.
  • Cross-functional coordination with others as it relates to area of expertise.
  • Interacts with regulatory and partner auditors/inspectors.
  • Represents QA interests on special projects related to area of expertise.

 

Education:

  • Bachelor's Degree in Life Science, Physical Science or a related discipline

 

Experience:

  • Minimum of 6 years work experience, with a minimum of 4 years in a regulated (GMP/ISO/QSR) industry. QA experience desirable.
  • Ability to quickly and logically evaluate and solve simple – moderately complex problems on a daily basis. 
  • Ability to clearly and concisely document results of simple projects, evaluations or investigations.

 

Knowledge, Skills, and Abilites:

  •  Knowledge of regulations and standards affecting medical devices, IVDs and Biologics including ISO 9001, ISO 13485, Eu In-Vitro Diagnostics or Medical Device Directives, and FDA regulations.
  •  Must have strong written and oral communication skills.
  • Certified lead auditor (i.e., ASQ CQA, ISO, or equivalent)
  • Strong collaboration with cross-functional groups to ensure consistent application of quality systems / processes across the site
  • Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
  • High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
  • Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
  • Training and mentoring of other members of the Compliance organization.
  • Advanced computer skills with Word, Excel, and PowerPoint.
  • Must be able to travel 30% of the time.

 

Additional Responsibilites:

  • Lead external and internal audits according to Grifols Diagnostic Solutions’ requirements, including scheduling, preparation of agenda and audit reports, management of Corrective and Preventive Action responses, audit follow-up, audit closure and appropriate escalation of audit findings.
  •           o Audits are conducted in accordance with cGMPs, ISO Standards, CFRs, CMDRs, and company procedures.
  • Manage the Grifols Diagnostic Solutions Third Party and Supplier program maintaining quality questionnaires, quality agreements, risk assessment and risk mitigation, performance monitoring, and other maintenance or exit activities.
  •          o  Act as Single Point Of Contact (SPOC) for Third Parties and Suppliers to escalate audit findings, manage deviations, performance problems and CAPA responses, maintain communication and quality records.
  •          o Ensure that quality agreements with Third Parties and Suppliers are reviewed and updated as needed and that monitoring reports are completed as required.
  •          o Maintain an approved Third Party, Supplier, and Service Provider list.
  •          o Manage appropriate corrective / preventative actions to findings and implement in a harmonized and timely fashion.
  •          o Manage Compliance Key Performance Indicators as required by site and regulatory requirements.  Examples are: Site Quality Committee and Management  Review KPIs
  •          o Compile, prepare, review, and drive investigations and CAPAs related to Supplier Corrective Action Requests (SCARs).
  • Provide support for managing all regulatory Health Authority inspections, responses and follow-up actions.
  • Support customer audits, responses, and follow-up actions.
  • Provide guidance in remediating compliance deficiencies.
  • Drive continuous improvements related to Compliance systems and processes against current Compliance requirements.

Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters 

 

Learn more about Grifols