Quality Control In-Process Analyst

BioTalent; California (MO); On-site; USD 35,500 - 44,372; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

BioTalent is seeking a Quality Control In-Process Analyst to perform testing and sampling in a GMP environment, supporting manufacturing, validation, and stability studies.

You will execute compendial tests, prepare buffers, conduct aseptic sampling, and ensure compliance with cGMPs, collaborating with multiple departments. This full-time role offers competitive pay and benefits.

Qualifications

• Bachelor’s degree or 2-4+ years biotech QC/analytical lab experience.
• Experience with analytical testing, GMPs, and regulatory audits.
• Familiarity with analytical instrumentation maintenance and troubleshooting.

Responsibilities

• Perform compendial test methods, analyze data, and report results.
• Formulate buffers and reagents for testing.
• Write and revise test methods and procedures.
• Conduct aseptic sampling, endotoxin testing, and pH/conductivity/osmolarity checks.
• Perform water testing and raw material sampling/testing.
• Execute QC testing for lot release, stability, and development/validation projects.
• Write study protocols and reports.
• Collaborate with other departments to develop QC procedures and policies.
• Ensure compliance with cGMPs and industry regulations.
• Perform sample pickup and locating.
• Other duties as assigned.

Skills

Biotech QC experience

Analytical testing

GMP compliance

Regulatory audits

Instrumentation troubleshooting

Data analysis and reporting

Education

Bachelor’s degree in a life sciences field

Job description

Join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals. We are seeking a Quality Control In-Process Analyst to perform testing and sampling to support manufacturing, validation, process development, and stability studies in a GMP environment.

Key Responsibilities:

• Perform compendial test methods, analyze data, and report results.
• Formulate buffers and reagents for testing.
• Write and revise test methods and procedures.
• Conduct aseptic sampling, endotoxin, pH, conductivity, osmolality, A280, and endotoxin by LAL.
• Perform water testing and raw material sampling/testing.
• Execute QC testing for lot release, stability, development/validation projects, and investigations.
• Write study protocols and reports.
• Collaborate with other departments to develop and implement QC procedures and policies.
• Ensure compliance with cGMPs and industry regulations.
• Perform sample pick up and locating.
• Other duties as assigned.

Minimum Qualifications:

• Bachelor’s degree or 2-4+ years of biotech industry experience in a QC or analytical lab.
• Experience with analytical testing, report writing, GMPs, and regulatory audits.
• Familiarity with the methodologies listed above.
• Experience with maintenance and troubleshooting of analytical instrumentation is highly desirable.

Schedule:

• Full-time, Sunday through Wednesday (4x10 schedule).
• Adaptable schedule to meet operational demands.
• Overtime and weekend availability as needed.
• Hourly rate: $25.77 to $32.21, depending on experience and qualifications.
• Competitive compensation package including base salary, performance-based bonuses, health, dental, and vision insurance, 401(k) matching, and paid time off.
• Opportunities for career growth and a supportive, inclusive work environment.

Who You Are:

• Team player with a positive attitude.
• Strong written and verbal communication skills.
• Exceptional multitasking and attention to detail.
• Skilled at building relationships with team members, clients, vendors, and suppliers.

Applicants must be legally authorized to work in the United States for any employer. Sponsorship is not available for this position now or in the future.