Sr. Analyst, Quality Control

Posted 13 Days Ago
Be an Early Applicant
Tustin, CA, USA
In-Office
32-40 Hourly
Senior level
Healthtech • Pharmaceutical
Transforming the CDMO experience: Unrivaled expertise. Worldclass facilities. Exceptional quality. Personalized process.
The Role
Performs and reviews GMP quality-control testing and sampling for biopharmaceutical manufacturing, validation, process development, and stability studies. Conducts ELISA, cell-based immunoassays, electrophoresis, and related analytical testing in cleanroom environments. Writes and reviews methods, SOPs, protocols, reports, and specifications; leads validation, investigations, and method-development projects; trains analysts; supports regulatory inspections and continuous improvement.
Summary Generated by Built In

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.

Skills Required

  • Bachelor's degree in biology, biochemistry, chemistry, or an equivalent scientific field
  • Minimum 4 years of relevant hands-on experience working in a GMP environment
  • Experience with analytical testing and equipment
  • Experience writing reports, procedures, and specifications
  • Knowledge of GMPs and regulatory audits
  • Strong cell-based assay, qPCR, ELISA, analytical biochemistry, and/or chemistry experience
  • Experience with cell-based assays, qPCR, electrophoresis, chromatography, aseptic techniques, and assay validation or qualification
  • Ability to work full-time onsite Monday through Friday, with overtime and/or weekends when necessary

Avid Bioservices Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Avid Bioservices and has not been reviewed or approved by Avid Bioservices.

  • Healthcare Strength Health coverage includes medical, dental, and vision alongside life and disability insurance. Plan breadth is presented as solid, with health benefits frequently highlighted as a strong element of the package.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discounted purchase feature and the availability of stock grants provide accessible ownership opportunities. These components add long-term value beyond base pay.
  • Fair & Transparent Compensation Pay ranges are posted for some roles, offering upfront clarity on expected compensation. This transparency supports clearer expectations during hiring.

Avid Bioservices Insights

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The Company
HQ: Tustin, California
343 Employees
Year Founded: 2002

What We Do

Avid Bioservices is transforming the CDMO experience, with more than 30 years of unrivaled experience manufacturing biologics, and world-class mammalian protein facilities. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. We do it right the first time, which saves money and time. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners.

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