Operations Batch Review Specialist-IDAP

Overview

Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) while maintaining high quality standards. This role works directly with the operations team, providing coaching and feedback for corrections and documentation improvements. It also collaborates with the quality systems team to provide information and feedback for manufacturing deviation investigations and CAPA implementation.

The Operations Batch Review Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of audiences. They thrive in a team environment but can also work autonomously with strong self-management and organizational skills. They value process owners and subject matter experts and can influence positive outcomes without direct reporting authority.

• Full batch documentation review of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
• Identify corrections, deviations and escalate 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 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 to safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.

• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMPs.
• 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.).

• Experience as performer or reviewer in Quality Management Systems.
• Experience with assessment and review of Quality Control testing, CoA, and results management preferred.
• Knowledge of regulations and quality processes involving product disposition.

• Paid vacation days, amount based on tenure, and paid sick time
• 11 observed holidays
• 401(k) plan with company match up to 3.5% of salary, vested immediately.
• Choice of health & wellness plans.
• FSA and HSA programs.
• Dental & vision care.

INCOG Bio Pharma is committed to a service-culture mindset, technical excellence, and a collaborative, team-centered approach to doing business. We seek individuals who want to build systems from scratch and contribute to delivering quality outcomes that accelerate our customers’ route to market.

Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG Bio Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by law. We will not tolerate discrimination or harassment based on any of these characteristics.

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