Specialist (OTF), Quality Assurance
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 Avid as a Quality Assurance Specialist (OTF) and be a critical part of ensuring top-notch quality for our products and services. As the QA Specialist within the Quality Assurance On-the-Floor (OTF) team, you will be responsible for providing quality oversight for clinical and commercial cell therapy operations, ensuring adherence to current Good Manufacturing Practices (CGMP), Good Documentation Practice (GDP), and Data Integrity/ALCOA+ principles, supporting right-first-time execution on the production floor.
Collaborate with manufacturing departments, enforce GMP requirements and QA policies, maintain a state of inspection readiness, and participate in designing and implementing department and cross-functional initiatives. You'll be part of a dynamic team committed to delivering high-quality products and services to our customers, in a fast-paced and innovative environment. If you're detail-oriented, highly organized, and looking for a challenging opportunity to grow and develop your skills, apply now to be a part of our team.
- Provide quality oversight of production floor to ensure manufacturing operations adhere to GMP and GDP requirements, including data integrity.
- Observe manufacturing operations and identify departures from clean room behaviors, aseptic techniques, and applicable procedures through process observations.
- Perform real-time review of executed batch records and manufacturing test forms to ensure compliance with procedures.
- Collaborate with Manufacturing teams to resolve discrepancies on-the-floor.
- Ensure timely escalation of any discrepancies to management.
- Provide support during regulatory inspections and other audits; maintain a state of inspection readiness.
- Perform other duties as assigned by Quality Assurance management.
Minimum Qualifications:
- Bachelor’s degree (preferably in the Life Sciences).
- 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.
Position Type/Expected Hours of Work:
This role is a full-time position operating on a Wednesday to Saturday or Sunday through Wednesday shift on a 4x10 (4 days x 10 hours) schedule, with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday, 8:00am to 5:00pm.
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 $27.00 to $36.77 hourly annually 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.