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Quality Assurance Specialist

2 months ago

California, United States Elixir Associates Full time

Company Overview:

Elixir Associates is collaborating with a dynamic Clinical Stage Biotech firm based in Southern California, seeking to expand their Quality Assurance (QA) team.

Position Summary:

The Quality Assurance Specialist plays a crucial role in overseeing the ongoing monitoring and maintenance activities linked to the Quality Management System (QMS). This is conducted in alignment with internal protocols, US FDA regulations, and relevant international standards across GCP, GMP, GLP, and GPVP.

Key Responsibilities:

  • Monitor compliance with the training program, maintain the Training Matrix for written procedures and refresher training, and support the onboarding process for new employees.
  • Initiate and coordinate the periodic review of controlled written procedures, Quality/Service Level Agreements, and supplier re-qualification cycles.
  • Work collaboratively across departments to develop and update written procedures, forms, and checklists.
  • Assist the QA team in creating training materials, scheduling programs, and ensuring documentation is completed.
  • Support the QA team with logistics, travel arrangements, and communication regarding quality audits.
  • Conduct internal debarment checks and track necessary documentation from suppliers.
  • Improve data integrity and documentation practices by transitioning paper-based forms and checklists to electronic systems.
  • Set up systems for regulatory intelligence under supervision, monitoring and distributing relevant outputs.
  • Compile documentation to facilitate the authorization of initial shipments of Investigational Medicinal Products (IMP) to clinical sites.
  • Track and analyze metrics for internal quality systems, including deviations, quality issues, and continuous improvement initiatives.
  • Assist the QA team in developing presentation materials and communication tools.
  • Ensure compliance with the document retention policy.

Qualifications:

  • A minimum of 3 years of relevant experience in a Quality Assurance support role within a regulated environment, preferably in the bio/pharmaceutical sector.
  • Strong attention to detail with the ability to maintain quality under time constraints.
  • Excellent administrative and communication skills.
  • Ability to follow directions and work effectively under pressure while adhering to compliance requirements.
  • Proficiency with electronic software and applications, including advanced skills in WORD, PowerPoint, Excel, Adobe, Visio, SmartSheet, Sharepoint, and BOX. Familiarity with technical terminology, data collection, graphic displays, and basic mathematical/statistical concepts is essential.
  • Flexibility to adapt to changing circumstances.
  • A college degree is required, preferably in a scientific discipline.

Compensation:

Competitive base salary, targeted yearly bonus, and comprehensive healthcare benefits.

For more opportunities in Quality Assurance, please follow our company page on LinkedIn.