Specialist, Quality Assurance

Specialist, Quality Assurance Avid Bioservices - 2.7 Tustin, CA Job Details Full-time $31.63 - $38.00 an hour 1 hour ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications Vendor relationship building Regulatory inspections Document review (document control) Pharmaceutical regulatory compliance GMP Mid-level Administrative experience Bachelor's degree Quality control documentation E-learning platforms LMS Training & development Quality assurance within manufacturing Cross-functional collaboration 2 years Stakeholder relationship building Training delivery Full 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:

The Quality Assurance Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

Key Responsibilities:

Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs). Perform administrative tasks associated with Avid's electronic Learning Management System. Review controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Track quality system records; send reminders to authors and approvers. Review change requests and assist with discrepancy investigations. Provide Quality oversight to internal and external customers. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Provide support during regulatory and other inspections; maintain a state of inspection readiness.

Minimum Qualifications:

Bachelor's degree (preferably in Life Science). 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 solution

Position Type/Expected Hours of Work:

This role is a full-time onsite position operating Monday through Friday. The employee must also, if instructed, be able to work overtime and/or weekends when needed.

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 $31.63-$38.00 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 ($31.63-$38.00 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.