DirectJobHub
Jobs · Quality Assurance · California

Specialist, Quality Assurance (Early Phase)

Avid Bioservices · Costa Mesa, CA · 3 wk ago
On-siteQuality Assurance$32.69–$40.86/hrFull-time

About the role

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. As a Quality Assurance Specialist (Early Phase), you will be an individual contributor solving a variety of issues following cGMP regulations and company standards while maintaining a state of inspection readiness.

You will collaborate with management to establish and meet targets, serve as a Quality representative on cross-functional teams, and identify solutions to potential procedure, process, and system gaps. This role involves providing assistance to customers, participating in departmental initiatives, and troubleshooting Quality issues through effective partnerships.

Responsibilities

  • Provide input to the development of personal performance goals and departmental objectives.
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Sign documents for activities as authorized by company policies and procedures.
  • Review Manufacturing Batch Production Records and associated forms.
  • Assist in the release of API batches and lots.
  • Assist with discrepancy investigations and write excursion reports.
  • Compile and review all records in Batch history records.
  • Review testing documentation from Microbiology and Chemistry groups.
  • Review and approve controlled documents relating to processes, equipment, facilities, and utilities.
  • Represent Quality Assurance on multi-disciplinary project teams.
  • Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
  • Provide Quality oversight to internal and external customers.
  • Collaborate with departments to ensure efficient execution of review activities per governing SOPs.
  • Generate departmental performance metrics for management review.
  • Perform assigned tasks to achieve company goals and department objectives.

Requirements

  • B.A. or B.S. degree (preferably in life science disciplines).
  • At least 2 years of experience in the biopharmaceutical industry.
  • Knowledge of cGMPs or equivalent regulations.
  • Ability to interpret quality standards for implementation.
  • Skills to independently evaluate situations and propose potential solutions.

Skills

  • Exceptional written and verbal communication with clarity and confidence.
  • Strong multitasking abilities and unparalleled attention to detail.
  • Proven ability to build relationships with team members, clients, vendors, and suppliers.
  • Team player with a positive attitude and readiness to tackle challenges.

Benefits

  • Comprehensive health, dental, and vision insurance.
  • 401(k) matching.
  • Paid time off.
  • Performance-based bonuses.
  • Opportunities for career growth and development.
  • Supportive and inclusive work environment.

Pay

The compensation range for this role is $32.69 to $40.86 hourly, depending on experience and qualifications.

Schedule

This is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by a supervisor. The employee must be able to work overtime and/or weekends when necessary.

Physical Demands & Work Environment

  • Blend of regular activities such as sitting, standing, and walking.
  • Occasional physically engaging tasks, including lifting objects up to 25 pounds.
  • Potential exposure to electrical shocks, toxic chemicals, vibrations, or loud noise levels.
  • Essential visual acuity, including close, distance, and color vision.
  • Reasonable accommodations available for individuals with different abilities.

Similar jobs