Associate Specialist, Quality Assurance

avidbio; Tustin (CA); On-site; USD 52,800 - 66,000; Full time

Job summary

Avid Bioservices is seeking an Associate Specialist in Quality Assurance to manage electronic document and training systems, issue and reconcile equipment logs, and train staff on quality processes and GMPs.

The role emphasizes QA policy enforcement, GDP adherence, and supporting inspections, ensuring readiness and collaboration across departments.

Qualifications

• Bachelor's degree in Life Science or equivalent required.
• Minimum of 1+ years of experience in the biopharmaceutical industry.
• Knowledge of CGMPs or equivalent regulations.

Responsibilities

• Admin tasks for electronic document management system.
• Admin tasks for electronic training system; assign curricula, generate reports, revise curricula.
• Issue and reconcile equipment logbooks and laboratory notebooks; manage controlled documents.
• File documents in QA archive and retrieve on request.
• Provide formal and informal training on quality systems, training and GMPs.

Skills

CGMPs knowledge

Quality standards interpretation

Communication

Multitasking

Relationship building

Education

Bachelor's degree in Life Science

Job description

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 $25.38 - $31.73 hourly depending on experience and qualifications.

We understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($52,800 - $66,000) 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.