Specialist, Quality Systems

Avid Bioservices; Tustin (CA); On-site; USD 90,632,000 - 120,806,000; Full time

Job summary

Avid Bioservices is seeking a Specialist, Quality Systems to support the Quality Management System, focusing on discrepancy processing and CAPA records. You will collaborate with cross-functional teams, maintain inspection readiness, and ensure regulatory compliance while delivering high-quality responses to internal and external stakeholders.

The role emphasizes data verification, deviation tracking, and ongoing improvement within a fast-paced biopharma environment onsite in California.

Qualifications

• 2–4 years of experience in Quality Assurance is required.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Skills to independently evaluate situations and propose potential solutions.

Responsibilities

• Update channels for tracking Quality Event deviation reports and CAPAs.
• Coordinate with cross-functional teams to meet due dates.
• Interact with interdepartmental contacts on discrepancy reports and CAPA records; represent Quality on teams.
• Perform data verification to ensure accuracy in Quality Events.

Skills

Quality Assurance

cGMPs

Data Verification

CAPA Management

Documentation

Cross-functional Collaboration

Education

Bachelor’s degree in Life Sciences

Tools

Quality Management Systems (QMS)

Electronic Document Management Systems

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:

Join our team as a Specialist, Quality Systems, where you will play a vital role in ensuring the integrity and compliance of our Quality Management System. Provide support within Quality Systems for the processing of Discrepancy reports and CAPA records, ensuring adherence to procedural and regulatory requirements. Collaborate with cross-functional teams, maintain inspection readiness, and provide exceptional support to internal and external customers. If you thrive in a fast-paced environment and are dedicated to delivering top-notch quality.

Key Responsibilities:

• Update existing channels for tracking Quality Event deviation reports and CAPAs.
• Work with cross-functional teams to maintain adherence to task due dates.
• Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams.
• Perform data verification to ensure accuracy of information presented in Quality Events.
• Gather supporting documentation for the investigation of Quality Events.
• Monitor CAPAs to maintain adherence to due dates.
• Perform Effectiveness Checks for existing CAPAs.
• Monitor Continuous Improvement pending items and workflows to ensure closure.
• Update trackers and pull information from Veeva QMS as necessary to ensure Quality Systems team is meeting necessary targets.
• Collaborate with Lead Specialist and Management to establish and meet targets and timelines.
• Ability to manage competing priorities with guidance from leadership
• Follow company policies and procedures.

Minimum Qualifications:

• Bachelor’s degree (preferably in Life Sciences field) or equivalent industry experience
• 2-4 years of experience in Quality Assurance is required
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Skills to independently evaluate situations and propose potential solutions.

Preferred Qualifications:

• Leverage critical thinking and strong attention to detail
• Experience in technical writing and editing skills
• 2+ years of experience in the biopharmaceutical industry (preferably with biologics).
• Experience in deviation records or CAPA management
• Ability to work independently
• Experience in use of quality systems software (quality management systems and/or electronic document management systems).

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also 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 $31.63 - $42.16 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

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 25 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.