Analyst (In-Process), Quality Control
About The Position
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
- Bachelor’s degree or 2-4+ years of biotech industry experience working in a QC or analytical lab.
- Experience with analytical testing, writing reports, GMPs, and regulatory audits.
- Experience with most, if not all the methodologies listed above (aseptic sampling, endotoxin, pH, conductivity, osmolality, A280 and endotoxin by LAL, water testing, raw material sampling and testing).
- Must have experience with analytical testing, writing reports, GMPs, and regulatory audits.
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.
- Write 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.
Benefits
- health, dental, and vision insurance
- 401(k) matching
- paid time off
- opportunities for career growth and development
- supportive and inclusive work environment
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
