Description

The Quality Control Analyst will be essential in reviewing GMP data across In-Process, Lot Release, and Stability studies. Your focus will be on delivering timely, high-quality results that meet the demands of our Manufacturing team. Additionally, you may take on responsibilities such as writing Quality Records, including Deviations, CAPA, and Change Control, as well as developing Forms and Test Methods.

Company Culture and Environment

We foster a collaborative and dynamic work environment that values precision, quality, and teamwork. Our culture encourages individual accountability while promoting a team-oriented atmosphere, ensuring that each team member can thrive and contribute effectively.

Career Growth and Development Opportunities

This position offers opportunities for personal growth and skill enhancement, especially for individuals looking to deepen their expertise in quality control processes in the biopharmaceutical industry.

Detailed Benefits and Perks

• Competitive salary based on experience
• Comprehensive health benefits
• Opportunities for overtime
• Access to professional development resources

Compensation and Benefits

• Competitive salary
• Health and wellness benefits
• Opportunities for overtime
• Professional development resources available

Why you should apply for this position today

Joining our team offers a unique opportunity to contribute to high-quality manufacturing processes while enhancing your skills in a fast-paced environment. If you are passionate about quality assurance in the biopharmaceutical industry and seek to make a meaningful impact, apply today!

Skills

• Proficiency in running and reviewing assays such as ELISA, HPLC, Gas Chromatography, qPCR, Western Blot, FTIR, A280s, CESDS, icIEF, Bioburden, and Wet Chemistry Assays
• Familiarity with Laboratory computer systems and Microsoft Office Suite (Word, Excel, PowerPoint)
• Knowledge of GMP Quality Systems like TrackWise, LIMS, and Empower3
• Strong written and verbal communication skills
• Ability to work independently and collaboratively within a team
• Skilled in process-related tasks, data interpretation, and problem-solving

Responsibilities

• Review GMP data for In-Process, Lot Release, and Stability studies
• Provide high-quality results to meet Manufacturing demands
• Write Quality Records, including Deviations, CAPA, and Change Control
• Develop and maintain Forms and Test Methods
• Work independently and as part of a team to achieve goals
• May require working overtime as needed

Qualifications

• Bachelor or Associate’s Degree in Biochemistry, Chemistry, Microbiology, or a related Science field
• 3-5 years of relevant experience in a cGMP environment preferred
• Proven experience in laboratory assays and quality control processes
• Strong communication skills, both written and verbal

Education Requirements

• Bachelor’s or Associate’s Degree in a related field

Education Requirements Credential Category

• Biochemistry, Chemistry, Microbiology, or Related Science field

Experience Requirements

• 3-5 years of experience in quality control and laboratory testing, preferably in a cGMP environment
• Experience running and reviewing various laboratory assays

Why work in Hayward, CA

Hayward, CA offers a vibrant community with a perfect blend of suburban comfort and urban convenience. With a rich variety of dining, shopping, and outdoor recreation options, Hayward provides an excellent quality of life. The location is within proximity to major tech hubs and beautiful landscapes, making it an ideal place to work and live.