Analyst, Quality Control

avidbio; Costa Mesa (CA); On-site; USD 34,000 - 44,000; Full time

Job summary

Avid Bioservices is seeking an Analyst, Quality Control to join its onsite team in a GMP environment. You will perform testing and sampling to support manufacturing, validation, process development, and stability studies.

The role requires a Bachelor's degree in a scientific field or 2+ years of QC lab experience, with proficiency in ELISA and analytical methods. The position offers traditional M-F hours and potential overtime.

Qualifications

• Bachelor’s degree in biology, biochemistry, chemistry or equivalent scientific field or a minimum of 2 years of relevant, hands-on experience working in a QC or analytical lab or equivalent combination of education/experience.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.
• Must be proficient with ELISA, Analytical Biochemistry or chemistry.

Responsibilities

• Perform and review routine assays for HPLC, ELISA/cell-based immunoassays, and/or electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures.
• Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
• Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support 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.
• Participate in regulatory inspections.
• Support continuous improvement initiatives.
• Other duties as assigned.

Skills

ELISA proficiency

GMP knowledge

Regulatory awareness

Documentation writing

Education

Bachelor’s degree in biology/biochemistry/chemistry

2+ years QC/analytical lab experience

Tools

HPLC

SDS-PAGE/IEF

ELISA instruments

Spectrophotometry

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:

TheAnalyst, Quality Controlwill perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment.

Key Responsibilities:

• Perform and review routine assays for HPLC, ELISA/cell-based immunoassays, and/or electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures.
• Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
• Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support 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.
• Participate in regulatory inspections.
• Support continuous improvement initiatives.
• Other duties as assigned.

Minimum Qualifications:

• Bachelor’s degree in biology, biochemistry, chemistry or equivalent scientific field or a minimum of 2 years of relevant, hands-on experience working in a QC or analytical lab or equivalent combination of education/experience.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.
• Must be proficient with ELISA, Analytical Biochemistry or chemistry.

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday, 8:00a.m. to 5:00p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, 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 $25.76 - $32.21 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 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.