Process Specialist

Process Specialist

The Process Specialist is responsible for working directly with the operations team and is to work closely with the quality systems team to provide information and/or feedback for manufacturing deviation investigations and CAPA implementation.

Additionally, the Process Specialist will possess aseptic manufacturing knowledge to serve as subject matter expert and demonstrate ability to influence positive outcomes without direct reporting authority. The Process Specialist is expected to champion cross-functional process improvement projects that address process gaps and process efficiency while maintaining quality results.

The Process 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. Authoring comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.

Process Specialist – (I / Associate)

To work closely with MFG and QA systems to investigate deviations related to MFG activities. This specialist will be assigned straightforward CAPA related to SOP/WI revisions.

Process Specialist – (II / Base)

To work closely with MFG and QA systems to provide support for deviation investigation and CAPA implementation. This specialist is expected to champion cross-functional process improvement projects that address process gaps and process efficiency. Support client and regulatory audits for MFG department.

Process Specialist – (III / Senior)

To work closely with MFG and QA systems to serve as an SME during client or regulatory audits. This specialist is expected to champion major site/multi-departmental or client process improvement projects that address process gaps and process efficiency. Serve as a management delegate for process update decisions and meetings.

Essential Job Functions:

• Support authoring, reviewing, and approving various SOPs & Work Instructions and if needed create news to improve efficiency.
• Directs or conducts studies to ascertain the best sequence of operations or workflow.
• Experience with time studies, work measurement, engineering standards and data collections.
• Review employees and department productivity and partner with operations to develop action plans to improve performance.
• Maintain effective communication with other departments and employees.
• SME for processes related to preparation, formulation, and filling
• Strong change management skills to challenge the status quo and drive improvements.
• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills
• Lead root cause analysis activities for complex operational challenges, utilizing tools such as fishbone diagrams, 5 Whys, and statistical analysis
• Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients.
• Ability to work well autonomously managing multiple projects and within a team in a fast-paced and deadline-oriented environment.
• Ability to work with and influence peers and senior management.
• Self-motivated with critical attention to detail, deadlines and reporting
• Participate and support equipment/process FMEAs to understand process and product risks.
• Participate and report to a cross-functional team to advance project activities.
• Work flexible hours for the coverage of project demand.
• Other duties as assigned
• Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity in batch records.
• 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.
• Batch record and associated manufacturing report review experience.
• Deviation and technical writing experience.
• Client and Regulatory Agency audit experience.
• 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:

• 1-2 years demonstrated working knowledge of aseptic manufacturing operations.
• 1-2 years in a people leadership role

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:

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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