Analyst (In Process) Quality Control
About The Position
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 Quality Control In-Process Analyst will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment for the Quality Control In-Process team. Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results. Formulate buffers and reagents for the purpose of performing test methods. Write and revise test methods and procedures. Perform aseptic sampling, endotoxin, pH, conductivity, osmolality, A280 and endotoxin by LAL. Perform water testing and raw material sampling and testing. Perform QC testing for lot release, stability, development/validation projects, and investigations. Other functions include writing study protocols and reports. Work with other departments in developing, revising and implementing QC procedures and policies. Should be aware of company cGMPs as well as industry regulations that apply to all job functions. Perform sample pick up and sample locating without supervision and with strict adherence to written protocols. Other duties as assigned.
Requirements
- BS degree in Biochemistry, Chemistry, Biology or a related field
- 2 years of biotech industry experience working in a QC or analytical lab
- Must have experience with analytical testing, writing reports, GMPs, and regulatory audits
- Experience with most, if not all the methodologies listed above
Nice To Haves
- Experience with basic maintenance and troubleshooting of analytical instrumentation is highly desirable
Responsibilities
- Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment
- Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results
- Formulate buffers and reagents for the purpose of performing test methods
- Write and revise test methods and procedures
- Perform aseptic sampling, endotoxin, pH, conductivity, osmolality, A280 and endotoxin by LAL
- Perform water testing and raw material sampling and testing
- Perform QC testing for lot release, stability, development/validation projects, and investigations
- Writing study protocols and reports
- Work with other departments in developing, revising and implementing QC procedures and policies
- Be aware of company cGMPs as well as industry regulations that apply to all job functions
- Perform sample pick up and sample locating without supervision and with strict adherence to written protocols
- Other duties as assigned
Benefits
- 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.
- Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
251-500 employees
