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Mogi I/O : OTT/Podcast/Short Video Apps for you · 22 hours ago

IPQA Specialist – Inhalation Products

New Brunswick, NJ

Full-time

Onsite

Mid, Senior Level

$43K/yr - $62K/yr

3+ years exp

Mogi I/O is a company focused on OTT, podcast, and short video applications, and they are seeking an IPQA Specialist for Inhalation Products. The role involves ensuring product quality throughout pharmaceutical manufacturing and packaging operations, with a focus on compliance with cGMP and FDA regulations, particularly for Dry Powder Inhaler (DPI) products.

ContentInternetSoftwareSoftware EngineeringVideo

Growth Opportunities

Responsibilities

Ensure proper cleaning, line clearance, and readiness of manufacturing and packaging equipment

Perform SAP (ERP) transactions, including posting dispensed materials and sample records

Support investigations related to Deviations, OVerify raw materials during the dispensing process to ensure accuracy and compliance

Dispense printed packaging materials to packaging operations as per approved procedures

Perform in-process quality checks during manufacturing and packaging in accordance with batch records

Collect in-process, finished product, and validation samples per approved protocols

Perform Blend Uniformity (BU) sampling, including cleaning and maintenance of sampling tools

Conduct IPQA testing on the manufacturing floor, including:

Loss on Drying (LOD)

Bulk Density

Tapped Density

Leak Testing

Weight Variation testing

OS, OOT, and non-conformances

Review batch records, equipment and area logbooks, calibration records, and PMP documentation

Ensure proper identification, segregation, and documentation of rejected materials

Review engineering and environmental records, including temperature and humidity data

Conduct daily quality rounds on the manufacturing floor to ensure GMP compliance

Report and escalate shop floor issues and discrepancies to the QA Manager

Complete all required training assignments and adhere to company policies, safety standards, SOPs, and cGMP requirements

Perform additional QA support activities as assigned by management

Qualification

CGMP knowledgeFDA regulationsIPQA activitiesSAP ERP systemsPharmaceutical experienceMicrosoft Office proficiencyAttention to detailProblem-solving skillsOrganizational skillsCommunication skills

Required

Bachelor's degree in Science (minimum requirement)

Minimum 3–5 years of pharmaceutical industry experience

Strong knowledge of cGMP and FDA regulations (21 CFR Part 820)

Experience with IPQA activities and shop floor quality oversight

Familiarity with SAP ERP systems

Ability to read, write, and communicate effectively

Strong attention to detail and documentation accuracy

Self-motivated with the ability to manage multiple priorities in a fast-paced environment

Proficiency in Microsoft Word, Excel, and PowerPoint

Strong organizational and problem-solving skills

Preferred

3–15 years (Pharmaceutical manufacturing experience required; DPI preferred)

Experience with DPI, MDI, or Injectable products preferred

Company

Mogi I/O : OTT/Podcast/Short Video Apps for you

Mogi I/O is next generation, scalable and cost-effective delivery solution that enables online video providers (image optimization) to profit from their content by a superior video/image experience to billions

Founded in 2018

New Delhi, Delhi, IND

11-50 employees