Quality Assurance Specialist

empirical foods, inc.

$74K — $105K *
US-AnywhereRemote in South San Francisco, CA
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Life Sciences, Quality Management, Engineering, or a related field.
  • 2+ years of experience in quality assurance or regulatory compliance.
  • 1+ years in logistics or quality environment preferred.
  • Proficient in MS Word, Excel, and PowerPoint.
  • Familiarity with eQMS tools like Dot Compliance or similar.

Responsibilities

  • Oversee documentation control and ensure compliance with training and quality assurance processes.
  • Support investigations of non-conformances and deviations, promoting a safety-first culture.
  • Execute quality assurance activities aligned with global and local compliance standards.
  • Track quality KPIs and manage qualification processes for equipment and maintenance.
  • Assist in customer and supplier quality interactions, preparing for audits and assessments.
  • Ensure adherence to national and international quality legislation.
  • Evaluate the effectiveness of processes and changes to achieve desired outcomes.

Benefits

  • Medical, Prescription, Dental, and Vision insurance.
  • 401(k) plan with employer matching.
  • Paid Parental Leave and Pet Insurance.
  • Tuition Reimbursement for continuing education.
  • Generous vacation policy including personal and sick leave.
  • Support for volunteering and community service activities.
Full Job Description
Overview
The Quality Assurance Specialist is responsible for supporting and leading all quality management processes across the organization, applying specialized quality expertise at operational stations and serving as a key liaison for global and local stakeholders. This role will ensure the organizations alignment is within company standards. Responsibilities include managing documentation in accordance with applicable policies and procedures, monitoring training compliance, supporting non-conformance support, maintaining quality KPIs and equipment and/or maintenance dashboards, providing customer, audit, and supplier-related quality support. Responsibilities
  • Documentation, Training & Continuous Improvement:Provides support and oversees documentation control, ensures accuracy and compliance, coordinates related training, and identifies continuous improvement opportunities across global quality assurance processes.
  • Non-Conformance, Deviations & Reporting:Supports investigation and coordination and resolution of global non-conformances and deviations, including near miss reporting to strengthen safety and improvement culture. Ensuring safety of employees and continuous improvement opportunities.
  • Quality System Compliance (ISO, CEIV, GDP, etc.):Execute and maintain quality assurance activities aligned with applicable global and local standards and certifications.
  • Quality KPI, Equipment & Qualification Support:Provide data, KPI tracking, and qualification support to ensure quality targets and equipment/maintenance requirements are met on time.
  • Customer, Supplier & Audit Support:Support customer and supplier quality interactions and assist in preparing for and participating in internal and external audits.
  • Regulatory Compliance:Ensure adherence to national and international legislation across all relevant quality assurance processes.
  • Change Effectiveness & Process Evaluation:Assess the effectiveness of changes to processes, procedures, and forms to ensure intended outcomes are achieved.
  • Training Monitoring & Compliance:Set up, confirm, and monitor training related to documentation management and ensure completion and compliance through training dashboards.
  • Quality Projects:Contribute to defined quality projects that support organizational goals and continuous improvement.
  • Performs other duties as assigned
  • Complies with all policies and standards
  • The wage range for this position is $74,840.00-$105,660.00 and may vary based on geography as well as relative knowledge, skills, abilities, and experience
Qualifications Education Bachelor's Degree in Life Sciences, Quality Management, Engineering, or a related field (required) Experience 2+ years years of experience in quality assurance, regulatory compliance, or a related operational quality role. (required)  1+ years work experience in logistics and/or quality environment (preferred) Knowledge, Skills, and Abilities MS Word, MS Excel, MS Powerpoint Medium Some Cargowsie Experience Medium Dot Compliance or another eQMS experience Medium SharePoint Medium Some Logistics experience Medium Licenses and Certifications - Quality Certification (preferred) What AIT Can Offer You

In addition to your base compensation, you may be eligible for a bonus based on achievement of business and/or individual performance metrics (dependent on position). Benefits offered include Medical, Prescription, Health Savings Account, Flexible Spending Accounts, Dental, Vision, Life, AD&D, Disability, Supplemental Health, Employee Support, Paid Parental Leave, Pet Insurance, 401(k) and Tuition Reimbursement. In addition, teammates may be eligible for up to 10 to 20 days of vacation (depending on tenure), 2 personal days, 1 floating holiday, 5 sick days, 5 volunteer hours, and 6 company holidays (plus Veterans Day for Veterans) annually.

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