Analyst II

Job Summary:

NKGen Biotech is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Responsibilities:

Execute molecular biology biochemical microbiological and physicochemical testing on raw materials n-process samples and final products to support GMP manufacturing.

Perform incoming material inspection and release testing to verify that raw materials meet established quality specifications prior to use.

Perform microbiological testing including environmental monitoring (ISO 5/7/8) sterility testing (FTM/TSB and automated BacT systems) plate reading colony counting and documentation of results.

Operate maintain and perform routine verification of laboratory instrumentation and computerized systems (e.g. LIMS) in accordance with GMP requirements.

Maintain laboratory and QC inventory including monitoring laboratory supplies reagents and consumables and coordinating replenishment as needed.

Follow aseptic techniques and gowning procedures required for work in classified cleanroom environments.

Review document and maintain laboratory records in compliance with company SOPs FDA regulations GLP cGMP and data integrity requirements.

Author revise and maintain SOPs test methods specifications and technical documentation to support GMP operations and continuous improvement.

Support batch release stability studies investigations deviations CAPAs and change controls as required.

Collaborate with QA Manufacturing and other cross-functional teams to resolve quality-related issues and support manufacturing operations.

May perform other duties as assigned.

*The company reserves the right to add or change duties at any time

Job Qualifications & Skills

Bachelors degree in a life science field such as Biology Chemistry or Biochemistry.

24 years of experience in a GMP-regulated QC laboratory within the biotechnology pharmaceutical or cell therapy industry.

Hands-on experience with microbiological techniques including aseptic technique environmental monitoring sterility testing and microbial culture.

Experience with analytical techniques such as flow cytometry (FACS) ELISA spectrophotometry or other laboratory instrumentation.

Experience working with LIMS or other laboratory data management systems is preferred.

Knowledge of FDA GLP cGMP ALCOA data integrity principles and laboratory documentation practices.

Demonstrated ability to independently perform routine laboratory testing identify basic technical issues and perform first-level troubleshooting.

Strong organizational skills with the ability to manage multiple priorities and meet established timelines.

Proficiency in Microsoft Office (Excel Word PowerPoint); experience with statistical software is a plus.

Excellent verbal and written communication skills with the ability to work effectively in cross-functional teams.

Ability to work in a fast-paced start-up environment with minimal supervision.

Flexibility to work weekends holidays overtime or off-shift hours as business needs require.

Candidates must be authorized to work in the United States and successfully complete a background check.

Benefits & Perks

Competitive compensation

Medical Dental and Vision Insurance

Business casual work attire

Compensation:

$33-$35 hourly rate dependent on experience

Classification: Full-time non-exempt