Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist. The Sr Quality Assurance Specialist performs the assessment, review, and approval of QMS changes at Grifols San Diego. This includes change controls, validation documentation, and SOP / work instruction updates. Additionally, the Sr. Quality Specialist is responsible to uphold and improve quality standards, procedures, and systems. To succeed in this role, we are seeking individuals with at least a BA or BS in biology, chemistry, biochemistry or biomedical engineering (Quality certification from American Society for Quality or equivalent is a plus). Along with 5-8 years related quality experience (with a Bachelors) or a master's degree with 3-6 years of experience. Primary Responsibilities + Assesses and approves validation protocols & reports. Manages validation deviations. + Reviews and approves documentation changes to SOPs and work instructions. + Acts as owner/coordinator of change controls and performs QA assessment to ensure compliance. + Review/update/create SOPs to standardize the investigation process. + Applies knowledge of medical device regulatory requirements to support changes to the QMS. + Leads cross-functional teams to establish appropriate processes for product quality improvements. + Represents QA interests on special projects related to area of expertise. + Interacts with regulatory and partner auditors/inspectors. Knowledge, Skills, and Abilities + Advanced knowledge of complaint handling, nucleic acid testing instrument (hardware and software), QC, Manufacturing & Inventory processes + Working knowledge of SAP/Salesforce, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of graphs. + Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential. + Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation. + Ability to train and mentor within and outside the group Education Requires BA or BS in biology, chemistry, biochemistry or biomedical engineering. Quality certification (from American Society for Quality or equivalent) is a plus. Experience 5-8 years related quality experience in Quality or a Master's degree with 3-6 years of experience. 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. Pay Scale The estimated pay scale for the Senior Quality Associate role based in San Diego, California is $108,026.40 to $135,033 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.** Learn more about Grifols ( **Req ID:** 526403 **Type:** Regular Full-Time **Job Category:** Quality

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