Sr Quality Assurance Specialist

RXinsider LTD.; United States; On-site; USD 108,000 - 140,000; Full time

Benefits offered by this job

Bonus pool up to 8%

Medical, Dental, Vision

PTO and Holidays

401(k) match

Job summary

Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist in San Diego, CA. The role manages nonconformances, CAPAs, and change controls, reviews manufacturing docs, and mentors staff.

You will lead QA in audits, support risk assessments, and drive continuous quality improvements across operations. Ideal candidates have a BA/BS in biology or related field, ASQ certification is a plus, and 5–8 years of relevant quality experience (or a master’s with 3–6 years).

Qualifications

• Requires BA/BS in biology, chemistry, biochemistry or biomedical engineering.
• Quality certification (ASQ or equivalent) is a plus.
• 5–8 years related quality experience (or master’s with 3–6 years).

Responsibilities

• Independently manages QN, CAPAs and CC records related to production quality.
• Reviews SOPs, work instructions and manufacturing instructions.
• Investigates reagent non-conformances and complaints with cross-functional teams.
• Updates/creates SOPs to standardize investigations.

Skills

QN handling

CAPA management

Change Control

SAP

Veeva

Data trending

Communication skills

Mentoring

Education

BA/BS in biology, chemistry, biochemistry or biomedical engineering

Quality certification (ASQ or equivalent)

Tools

SAP

Veeva

Microsoft Word

Excel

PowerPoint

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 manages independently nonconformances, and CAPA records, ensuring timely corrective actions and comprehensive documentation. They also provide QA document review, impact assessment and risk analysis for document updates and Change Controls. They lead quality meetings, represent QA in daily meetings, and drive quality improvements through operational analysis and compliance audits. The role involves improving procedures, conducting risk assessments, preparing for audits, managing metrics, mentoring junior staff, and developing training programs. Additionally, they review and approve manufacturing documents, lead projects, make data-driven decisions, facilitate training sessions, and act as a backup to the department Manager.

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 relatable quality including nonconformances, CAPAs, compliance audits, (with a Bachelors) or a master’s degree with 3-6 years of experience.

Primary Responsibilities

• Independently manages QN, CAPAs and CC records related to production quality.
• Independently reviews documents such as SOP, work instructions, manufacturing instruction
• Independently conducts reagent related non-conformances and complaints investigation (immunohematology) through interfacing with Manufacturing, manufacturing sciences, planning, quality control and quality compliance to document and obtain detailed information/returns regarding the nonconformities and complaints, performing deeper investigation into root causes, assigning additional actions as necessary to close the record, performing data trending and preparing periodic reports relating quality issues.
• Review/update/create SOPs to standardize the investigation process.
• Applies knowledge of medical device regulatory requirements to identify reportable events as they are received, support the reporting decision process, and coordinate Product Quality Committee meeting to determine appropriate plans for actions to be taken. Provide track and trending for PHSC.
• Leads cross-functional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements. Ensures implementation/sustainability and monitors the field quality of the improvements.
• Represents QA interests on special projects related to area of expertise.
• Acts as an SME with regulatory and partner auditors/inspectors e.g. FDA.

Knowledge, Skills, And Abilities

• Advanced knowledge of QN handling, CAPA management, Change Control Process, QC, Manufacturing & Supply Chain processes
• Working knowledge of SAP and Veeva, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of graphs.
• Knowledge of molecular biology, cell biology, transfusion medicine and blood banking techniques (immunohematology).
• Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.
• Good communications skills are 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 complaint handling and investigation 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.

The estimated pay scale for the Senior Quality Associate Specialist role based in San Diego, California, is $108,026.40 to $140,000. 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, life insurance, PTO, paid holidays and 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!

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

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Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

Learn more about Grifols