Batch Documentation & Quality Review Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Paid vacation days

11 observed holidays

401(k) plan with company match

Health & wellness plans

FSA and HSA programs

Dental & vision care

Job summary

INCOG BioPharma Services is seeking an Operations Batch Review Specialist in Fishers, IN to review batch records post-execution ensuring cGMP and SOP compliance. You will coach operators, support deviations investigations, and collaborate with the Quality Systems team to improve on-the-floor documentation.

The role requires strong written and verbal communication, the ability to influence improvements without direct reporting authority, and prior GMP experience in a parenteral manufacturing

Qualifications

• . 4 years minimum experience working in a GMP environment.
• . Excellent written and verbal communication skills.
• . Knowledge of process control and quality engineering.
• . Familiarity with cGMP and regulatory requirements.
• . Experience with data analysis software such as Word, Excel, Visio, JMP, Minitab.

Responsibilities

• Full batch documentation review of parenteral manufacturing Batch Records for Media Fills and Drug Product.
• Identify corrections, deviations and elevate issues to Operations and Quality Supervisors.
• Provide training and feedback to Operators and Supervisors to improve on-the-floor Batch Record reviews.
• Support Quality Systems with timely completion of batch impacting deviations for on time batch release.
• Initiate deviations and participate in investigations for root cause and mitigation.
• Assist in authoring, reviewing and approving SOPs & Work Instructions.
• Prioritize and coordinate record reviews within production timelines.
• Utilize systems (eDMS, SCADA, BMS, CMMS, LIMS, lab software) to ensure data integrity.

Skills

GMP experience

Quality systems

Communication skills

Data integrity

Tools

SCADA

eDMS

BMS

CMMS

LIMS

Lab software

Job description

INCOG BioPharma Services is seeking an Operations Batch Review Specialist in Fishers, IN to review batch records post-execution ensuring cGMP and SOP compliance. You will coach operators, support deviations investigations, and collaborate with the Quality Systems team to improve on-the-floor documentation.

The role requires strong written and verbal communication, the ability to influence improvements without direct reporting authority, and prior GMP experience in a parenteral manufacturing