Sr. Analyst, Quality Control

Avid Bioservices; Tustin (CA); On-site; USD 67,000 - 84,000; Full time

Job summary

Avid Bioservices in California is seeking a Sr. Analyst, Quality Control to support manufacturing, validation, process development and stability studies in a GMP environment.

The role requires strong experience with ELISA and cell-based immunoassays, as well as electrophoresis (SDS-PAGE/IEF). You may lead validation projects and write study protocols, while collaborating across departments to improve QC procedures.

Qualifications

• Bachelor's degree in biology, biochemistry, chemistry or equivalent scientific field.
• Minimum 4 years of hands-on experience in a GMP environment.
• Experience with analytical testing, writing reports/procedures/specifications, GMPs and regulatory audits.
• Strong cell-based assay, qPCR, ELISA, analytical biochemistry and/or chemistry experience.

Responsibilities

• Perform and review routine assays for ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) per written test procedures.
• Perform aseptic sampling, visual inspection, gowning and clean room work.
• Review, revise and write test methods, SOPs; may lead validation projects, investigations and method development.
• Write study protocols and reports; train other analysts; collaborate on QC procedures.
• Understand and apply company cGMPs and regulatory requirements.
• Participate in regulatory inspections.
• Support continuous improvement initiatives.

Skills

ELISA

Cell-based immunoassays

SDS-PAGE/IEF

qPCR

Analytical biochemistry

Chemistry

Education

Bachelor's degree in biology/biochemistry/chemistry or equivalent

Tools

ELISA equipment

SDS-PAGE

qPCR instruments

Chromatography

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 Sr. Analyst, Quality Control will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. This position requires a strong background in ELISA/cell-based immunoassays and electrophoresis (SDS-PAGE/IEF) and supports/leads continuous improvement initiatives.

Key Responsibilities:

• Perform and review routine assays for ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures.
• Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
• Review, revise and write test methods, standard operating procedures and may perform trending analysis. In addition to performing QC testing, the Analyst may be designated as study Lead for validation projects, investigations and method development projects.
• Other functions include but are not limited to: writing study protocols and reports; training other analysts; working with other departments in developing, revising and implementing QC procedures and policies.
• Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.
• Participates in regulatory inspections.
• Support continuous improvement initiatives.

Minimum Qualifications:

• Bachelor's degree in biology, biochemistry, chemistry, or equivalent scientific field.
• Minimum 4 years of relevant hands‑on experience working in a GMP environment.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
• Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience.

Preferred Qualifications:

• Experience with cell-based assays, qPCR, electrophoresis, chromatography, aseptic techniques, and assay validation/qualification.

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 $32.30 - $40.38 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.