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Quality Assurance Specialist, IQC Summary

Working closely with the QA Operations Supervisor and IQC Supervisor. QA Specialist will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Specialist, IQC will need to provide support with identifying operational and quality gaps.

The Quality Assurance Specialist, IQC will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Specialist, IQC will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Specialist, IQC 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:

• Maintain a Quality Assurance presence and provide verification of incoming pharmaceutical shipments and contents against purchase orders, materials specifications and receiving in line with INCOG SOP's. Review and approve documentation, including but not limited to logbooks, material packets, material specifications, packing lists, work orders, procedures, etc.
• Collaborate with Supply Chain, IQC, and Operations team and lead or provide support with investigations to resolve inventory and material, consumables, and component related deviations.
• Support other QA personnel from Operations as necessary with batch record reviews, corrections, floor operations, etc.
• Inspect products for damage, discrepancies, or expired items and report any issues to the Warehouse Manager.
• Prioritize and coordinate his/her time in balancing timelines with product quality assurances.
• Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
• Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
• Provide Quality Assurance oversight into the picking of product Bill of Materials (BOM).
• Assist Supply Chain Management with Critical Alarm reporting with freezer farm or incubator alarms.
• Perform both provisional and full release of materials.
• Dispose of Filled Inspected Product (FIP) rejects following batch disposition.
• 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.
• Assist Operations with incoming and outgoing Material Transfer counts.
• Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
• Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
• Provide Quality Assurance oversight with Supply Chain inventory cycle counts and investigate any discrepancy.
• Ability to manage multiple projects in a fast-paced environment.
• Assist in maintaining records for regulatory inspections and audits.

Special Job Requirements:

• This position will support primarily first shift (7:00 am - 3:30 pm) with occasional weekend support, dependent on operations' needs.
• Bachelor's Degree required or equivalent; degree preferred to be in Logistics, Supply Chain, Management, Biology or Chemistry
• Minimum of 4 years with experience working as Quality in a GMP Manufacturing environment, Raw Material/ Component/Consumable release and/or as an Operator within a Pharmaceutical Supply Chain/Warehouse environment.
• Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..
• Understanding of Good Documentation Practices (GDPs) and its criticality.
• Ability to obtain Powered Industrial Lift Certification.
• Excellent written and verbal communication skills.
• Ability to lift 50 lbs.
• General computer skills evidenced by hands-on work with inventory management systems; and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Additional Preferences:

• Hands-on experience with aseptic manufacturing, inspecting finished products, and supply chain or warehousing.
• Experience with Continuous improvement, Six Sigma, and/or Lean principles.

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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