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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.

Summary

The Production Quality Specialist 3 ensures the quality and compliance of manufacturing operations and products. This requires resolving nonconformities and implementing effective CAPAs. Additionally, the Production Quality Specialist is responsible for upholding and improving quality standards, procedures, and systems.

Responsibilities

• Ownership, management, and processing of nonconformances, Out-of-Tolerance Reports, and CAPA records.

• Identifies and drives appropriate corrective and preventive actions to prevent recurrence of nonconformance events.

• Drives nonconformance investigations and CAPA records to ensure they are comprehensive and completed on time.

• Prepares detailed meeting agendas and leads meetings. Writes detailed meeting minutes and action items. Drives the progress of items on meeting agendas and reports progress.

• Represents QA at daily tier board meetings and Production Response Team meetings (PRTs).

• Observes and analyzes manufacturing operations. Provides on-the-floor oversight and monitoring of manufacturing processes. Conducts audits & inspections. Reports deficiencies and creates actions plans. Recommends quality improvements.

• Identifies and implements improvements to work instructions and procedures. Assists in developing quality systems & recommends improvements to existing Quality systems.

• Supports audit preparation and audit backroom activities. Address production quality questions with auditors as needed.

• Conducts simple to moderately complex risk assessments and QN investigations related to quality issues, deviations, and failures.

• Maintains and updates department metrics.

• Assists in mentoring junior Specialists and new hires.

• Drafts CAPA plans to address audit findings and submits for approval.

• Performs simple to moderately complex reviews & approvals of manufacturing instructions, procedures, and reports.

• Participates in the review and execution of test plans, reworks, date extensions, and temporary change controls to ensure quality standards are upheld.

• Leads and participates in simple to moderately complex projects. Supports projects from cross-functional and Quality teams.

• Makes Quality decisions based on data to address simple to moderately complex production issues. Escalates issues when needed.

Knowledge, Skills, and Abilities

• Working understanding of QSR & ISO requirements

• Advanced knowledge of QC, Manufacturing & Inventory processes

• Working knowledge of Microsoft Word, Excel, 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.

Education

Requires BA or BS in a biological or chemical science.

Quality certification (from American Society for Quality or equivalent) is a plus.

Experience

5-8 years related quality 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.

Occupational Demands

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously. Sedentary work involves sitting the majority of time. Jobs are sedentary if walking and standing are required only occasionally.

Pay Scale

The estimated pay scale for this Quality Specialist III role based in San Diego, CA, is $93,840 to $117,300 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!

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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 (https://www.grifols.com/en/what-we-do)

Req ID: 520975

Type: Regular Full-Time

Job Category: Quality