Associate Specialist, Quality Assurance

Posted An Hour Ago
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Tustin, CA, USA
In-Office
25-31 Hourly
Junior
Healthtech • Pharmaceutical
Transforming the CDMO experience: Unrivaled expertise. Worldclass facilities. Exceptional quality. Personalized process.
The Role
Administer electronic document and training systems, control logbooks and quality documents, archive and retrieve records, train coworkers on quality systems and GMPs, support customer requests and inspections, enforce QA and GDP requirements, and collaborate on cross-functional initiatives while maintaining inspection readiness.
Summary Generated by Built In
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? 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.
       
Your Role:       
As an Associate Specialist, Quality Assurance, you will be a critical part of ensuring top-notch quality for our products and services. You will be responsible for various administrative tasks associated with Avid's electronic document management and training systems, issuing, and reconciling equipment logbooks and laboratory notebooks, and providing both formal and informal training to coworkers on relevant processes such as quality systems, training, and GMPs. 
  • Perform administrative tasks associated with Avid's electronic document management system.
  • Perform administrative tasks associated with Avid's electronic training system; this includes, but is not limited to, assigning curricula, generating training reports, creating/revising curricula.
  • Issue and reconcile equipment logbooks, laboratory notebooks, controlled documents (including but not limited to, SOPs, forms, and logs).
  • File documents in the QA archive; retrieve documents from the archive upon request.
  • Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs).
  • Provide assistance to customers in support of departmental functions including, but not limited to, document revisions, internal/external request for documents.
  • Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
  • Participate in the design and implementation of department and cross-functional initiatives.
  • Enforce GMP requirements and QA policies, including Good Documentation Practices (GDP).
  • Provide support during regulatory and other inspections; maintain a state of inspection readiness.
  • Perform other duties as assigned by Quality management.
Minimum Qualifications:  
  • B.A. or B.S. degree (preferably in Life Science).  
  • Minimum of 1+ 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.  
Position Type/Expected Hours of Work:       
This role is a full-time onsite position. Days and hours of work are Monday through Friday, generally 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must have the ability to work overtime and/or weekends when necessary.
 
Compensation:       
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.       
       
The compensation range for this role is $25.00 - $31.25 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.     
 
We understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($25.00 - $31.25 hourly) plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being.
       
Who you are:       
  • You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:       
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.  

Skills Required

  • B.A. or B.S. degree, preferably in Life Science
  • At least 1 year of experience in the biopharmaceutical industry
  • Knowledge of current Good Manufacturing Practices (cGMPs) or equivalent regulations
  • Ability to interpret quality standards for implementation
  • Ability to independently evaluate situations and propose potential solutions

Avid Bioservices Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Avid Bioservices and has not been reviewed or approved by Avid Bioservices.

  • Healthcare Strength Health coverage includes medical, dental, and vision alongside life and disability insurance. Plan breadth is presented as solid, with health benefits frequently highlighted as a strong element of the package.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discounted purchase feature and the availability of stock grants provide accessible ownership opportunities. These components add long-term value beyond base pay.
  • Fair & Transparent Compensation Pay ranges are posted for some roles, offering upfront clarity on expected compensation. This transparency supports clearer expectations during hiring.

Avid Bioservices Insights

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The Company
HQ: Tustin, California
343 Employees
Year Founded: 2002

What We Do

Avid Bioservices is transforming the CDMO experience, with more than 30 years of unrivaled experience manufacturing biologics, and world-class mammalian protein facilities. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. We do it right the first time, which saves money and time. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners.

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