QC In-Process Analyst - Life-Saving Biologics Lab

Avid Bioservices; Tustin (CA); On-site; USD 26,000 - 44,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices, a leading biopharmaceutical CDMO, seeks a Quality Control In-Process Analyst to support manufacturing, validation, process development and stability studies in a GMP environment. You will perform testing, sampling and data analysis for in-process QC activities.

The role requires a bachelor’s degree or 2–4+ years in biotech QC, with experience in analytical testing, report writing, GMPs and audits. Willingness to work a 4x10 schedule and overtime as needed.

Qualifications

• Bachelor’s degree or 2–4+ years biotech industry experience in a QC/analytical lab.
• Experience with analytical testing, writing reports, GMPs, and regulatory audits.
• Experience with most, if not all the methodologies listed above.
• Experience with basic maintenance and troubleshooting of analytical instrumentation is highly desirable.

Responsibilities

• Perform basic compendial test methods without supervision and with strict adherence to written protocols; analyze data and report results.
• Formulate buffers and reagents for 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, development/validation projects, and investigations.
• Write study protocols and reports.
• Develop, revise and implement QC procedures and policies with other departments.
• Awareness of cGMPs and industry regulations applicable to all functions.
• Perform sample pick up and locating with strict adherence to protocols.
• Other duties as assigned.

Skills

Analytical testing

GMP knowledge

Regulatory audits

Instrument troubleshooting

Data analysis

Education

Bachelor's degree in biotech or related field

2–4+ years biotech QC experience

Tools

Analytical instruments

Job description

Avid Bioservices, a leading biopharmaceutical CDMO, seeks a Quality Control In-Process Analyst to support manufacturing, validation, process development and stability studies in a GMP environment. You will perform testing, sampling and data analysis for in-process QC activities.

The role requires a bachelor’s degree or 2–4+ years in biotech QC, with experience in analytical testing, report writing, GMPs and audits. Willingness to work a 4x10 schedule and overtime as needed.