GMP Batch Review & Quality Compliance Specialist

incog; Fishers (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Paid vacation

Holidays

401(k) match

Health plan

FSA/HSA

Dental & Vision

Job summary

INCOG BioPharma Services in Fishers, IN seeks an Operations Batch Review Specialist to ensure batch documentation meets cGMP/SOP requirements and quality standards. You will coach operators, support deviation investigations, and drive timely batch release activities.

Candidates should have 4+ years GMP experience, strong communication skills, and proficiency with SCADA and data analysis tools. The role emphasizes collaboration with Operations and Quality Systems to improve processes and

Qualifications

• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• 4 years minimum experience working in a GMP environment.
• Excellent written and verbal communication skills.
• General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Responsibilities

• Full batch documentation review of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
• Identify correction, deviations and elevate found issues to Operations and Quality Supervisors.
• Provide training and feedback to Operators and Supervisors to improve on-the-floor Batch Record reviews during execution.
• Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.
• Initiate deviations and participate in operations investigations for determining root cause and assessing mitigation for deviating events.
• Support authoring, reviewing and approving of various SOPs & Work Instructions.
• Prioritize and coordinate their record reviews within production timelines.
• Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity in batch records.
• Ability to manage multiple projects in a fast-paced environment.
• Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.

Skills

GMP Compliance

Batch Documentation Review

Quality Assurance

Process Improvement

Tools

SCADA

MS Office (Word/Excel/Visio)

JMP

Minitab

Job description

INCOG BioPharma Services in Fishers, IN seeks an Operations Batch Review Specialist to ensure batch documentation meets cGMP/SOP requirements and quality standards. You will coach operators, support deviation investigations, and drive timely batch release activities.

Candidates should have 4+ years GMP experience, strong communication skills, and proficiency with SCADA and data analysis tools. The role emphasizes collaboration with Operations and Quality Systems to improve processes and