Operations Batch 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

The 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 the highest possible quality standards. This position will work directly with the operations team and provide coaching and feedback for corrections and documentation improvements. This position will also work closely with the quality systems team to provide information and/or 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 target audiences. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. Additionally they will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

Essential Job Functions

• 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.

Special Job Requirements

• 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.).

Additional Preferences

• 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.

INCOG's Benefits

• 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.

Additional info about INCOG BioPharma Services

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma 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 the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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