Sr Quality Assurance Specialist

Grifols, S.A; San Diego (CA); On-site; USD 108,026 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Paid holidays

401(K) match

Tuition reimbursement

Job summary

Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist to manage nonconformances, CAPAs, and OOT reports while driving quality improvements. The role involves audits, risk assessments, training, and mentoring staff in a fast-paced biotech setting in San Diego, CA.

Candidates should have a BA/BS in biology/chemistry/biochemistry or biomedical engineering, with 5–8 years of quality experience (or 3–6 years with a Master’s) and may hold ASQ certification.

Qualifications

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

Responsibilities

• Investigate instrument-related complaints, document findings and trend data.
• Review, update and create SOPs to standardize investigations.
• Apply regulatory knowledge to identify reportable events and support actions.
• Lead cross-functional teams to drive product quality improvements.
• Represent QA on special projects and coordinate regional meetings.
• Interact with regulators/auditors and mentor junior staff.

Skills

Complaint handling

Nucleic acid testing instrument

Quality control

Manufacturing & Inventory processes

SAP

Salesforce

Microsoft Word

Excel

PowerPoint

Education

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

Tools

SAP

Salesforce

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 nonconformances, Out-of-Tolerance Reports, and CAPA records, ensuring timely corrective actions and comprehensive documentation. 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 Supervisor/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, and OOT reports (with a Bachelors) or a master’s degree with 3-6 years of experience.

Primary Responsibilities

• Independently conducts instrument related complaint investigation (nucleic acid testing) through interfacing with field reps. to acknowledge, document and obtain detailed information/returns regarding complaints, performing deeper investigation into root causes, assigning additional actions as necessary to close the complaint, performing data trending and preparing periodic reports relating to complaints and 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.
• Coordinates regional meetings with field service engineers and field service representatives.
• 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 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. 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!

• Medical
• Dental
• Vision
• life insurance
• PTO
• paid holidays
• up to 5% 401(K) match
• tuition reimbursement

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.