Grifols Shared Services North America, Inc Sr. QA Specialist in San Diego, California

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Headquartered in Barcelona, Spain, Grifols has nearly 18,500 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.

A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.

The QA Sr. Specialist manages their own activities related to their area of expertise (see Task List for specified activities). 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 related to area of expertise. Provides significant guidance to others regarding their area of expertise.

Primary responsibilities for role:

  • 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.

Additional Responsibilities:

  • Manage nonconformance and CAPA system data

  • Perform investigations related to manufacturing nonconformances, deviations or QC testing Out-of-Specification results including root cause analysis and product impact/risk assessments

  • QA oversight of manufacturing/product CAPAs

  • Change Management coordination, review, and approval

Knowledge, Skills, and Abilities:

  • Must have experience in analytical testing methods for in vitro diagnostic test kits for the analysis of finished products.

  • 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.

  • Ability to quickly and logically evaluate and solve simple- moderately complex problems on a daily basis.

  • Must be familiar with GMP's and Quality System Regulations

  • Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance

  • Equipment qualification, calibration and preventative maintenance programs

  • Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software.

  • Experience with Statistical Modeling software such as JMP or Minitab is strongly desirable.

Education:

Bachelor’s degree in Biochemistry, Molecular Biology, Immunology or in a Biological Science or relevant scientific field.

Experience:

Minimum of 6 years work experience focused on GMP laboratory analytical testing, with a minimum of 4 years in a regulated (GMP/ISO/QSR) industry. QA experience desirable.

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

EEO Minorities/Females/Disability/Veterans

CLK789

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home