Quality Assurance Specialist - Weekend Shifts

INCOG BioPharma Services; Fishers (IN); On-site; USD 60,000 - 85,000; Full time

Job summary

INCOG BioPharma Services is seeking a Quality Assurance Associate to ensure site compliance with regulations and ISO standards. You will support deviations investigations, batch record reviews, and material release while maintaining data integrity across systems (LIMS, CMMS, SCADA, etc.).

Weekend coverage is required with Friday–Sunday shifts. Ideal candidate has a Bachelor’s in science and 2+ years in GMP manufacturing QA, with strong written and verbal communication and knowledge of GDPs.

Qualifications

• Bachelor's Degree in Science or related field.
• Minimum of 2 years in GMP manufacturing QA or related pharmaceutical QA/Operator experience.
• Excellent written and verbal communication skills.
• Knowledge of GDPs and regulatory systems.

Responsibilities

• Maintain QA presence and confirm processes on the manufacturing floor.
• Review and approve quality documentation (batch records, logbooks, work orders, procedures).
• Lead or support investigations into deviations with root-cause analysis.
• Support batch record reviews and material release activities.
• Balance production timelines with product quality assurances.

Skills

Quality Assurance

Documentation

Regulatory compliance

Communication

Education

Bachelor's Degree in science or related field

Tools

JMP

Minitab

SCADA

LIMS

CMMS

Job description

INCOG BioPharma Services is seeking a Quality Assurance Associate to ensure site compliance with regulations and ISO standards. You will support deviations investigations, batch record reviews, and material release while maintaining data integrity across systems (LIMS, CMMS, SCADA, etc.).

Weekend coverage is required with Friday–Sunday shifts. Ideal candidate has a Bachelor’s in science and 2+ years in GMP manufacturing QA, with strong written and verbal communication and knowledge of GDPs.