Analyst (ELISA), Quality Control

United States·Tustinmid

OtherQuality Control

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Quick Summary

Overview

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.

Key Responsibilities

Excited about leveraging your expertise in ELISA/cell-based immunoassays and electrophoresis in a dynamic GMP setting? We are on the lookout for a dedicated Quality Control Analyst to be part of our innovative team!

Requirements Summary

Prior experience in a cGMP lab setting. You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.

Technical Tools

OtherQuality Control

Your Role:

Excited about leveraging your expertise in ELISA/cell-based immunoassays and electrophoresis in a dynamic GMP setting? We are on the lookout for a dedicated Quality Control Analyst to be part of our innovative team! In this role, you will engage in essential testing and sampling activities supporting manufacturing, validation, process development, and stability studies. You'll also have a chance to contribute to continuous improvement initiatives, ensuring our processes and procedures continually meet the pinnacle of quality standards. If you thrive in a multitasking environment, possess a keen eye for detail, and are self-motivated with a strong affinity for quality, we are eager to connect with you!

Conduct and review routine assays for ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF), adhering closely to written analytical test procedures and good documentation practices following the ALCOA system.
Undertake aseptic sampling, visual inspection, gowning, and uphold clean room standards.
Review, amend, and draft test methods and standard operating procedures; may also engage in trending analysis. Alongside regular QC testing, you may be entrusted as a study Lead for certain validation projects, investigations, and method development endeavors.
Additional duties encompass writing study protocols and reports, training fellow analysts, liaising with other departments to refine and implement QC procedures and policies, and managing the ordering of supplies and reagents for tests.
Stay adept with company cGMPs and relevant industry regulations pertaining to all job functions.
Participate in regulatory inspections and support continuous improvement initiatives.
Execute other assigned tasks as needed.

Minimum Qualifications:

B.S. in Chemistry, Biology, or a related field.
2+ years of industry experience in a QC or analytical lab, or an equivalent blend of education and experience.
Proficient in analytical testing and equipment, drafting reports/procedures/specifications, understanding of GMPs, and experience with regulatory audits.
Strong background in ELISA, along with a good grasp of Analytical Biochemistry and Chemistry principles.
Familiarity with several of the following is advantageous: protein characterization, electrophoresis, chromatography (normal phase, reverse phase, size exclusion, ion exchange, etc.), aseptic techniques, assay, and validation/qualification.

Preferred Qualifications:

Prior experience in a cGMP lab setting.

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.

Work Environment:

Regular requirement to sit, talk or hear, use hands to finger, handle or feel, or reach with hands and arms.
Frequent requirement to stand and walk.
Occasional requirement to climb or balance, stoop, kneel, crouch, or crawl.
Regularly lift up to 10 pounds.
Occasionally lift up to 20 pounds.
Specific vision abilities required include close vision, distance vision, and color vision.

Compensation:

We offer competitive compensation packages for this role, including a base salary, equity grants, 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 $26.73 to $35.63 per hour, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.