Production Quality Assurance Specialist 3

$93,840 - $117,300/Yr

Grifols - San Diego, CA

Full-time - Mid Level

San Diego, CA

Chemical Manufacturing

About the position

The Production Quality Specialist 3 at Grifols is responsible for ensuring the quality and compliance of manufacturing operations and products. This role involves resolving nonconformities, implementing effective corrective and preventive actions (CAPAs), and upholding quality standards and procedures. The specialist will also mentor junior staff and participate in cross-functional projects to enhance quality 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.

Requirements

• Requires BA or BS in a biological or chemical science.
• 5-8 years related quality experience.
• 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.

Nice-to-haves

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

Benefits

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