Quality Assurance Inspector - Osmotica Pharmaceuticals

Position Overview

The Quality Inspector is primarily responsible for supporting activities on the production floor. This includes room release, line clearance, in-process batch record review or post-executed review to ensure proper good documentation practices are followed. Provide quality oversight to all production areas to ensure product quality and compliance to cGMPs. This person works closely with operations personnel ensuring cGMP concerns are identified and resolved appropriately. Must be available/flexible to work second or third shift and weekends.

Duties and Responsibilities

• Required to be on-the-floor and present to provide quality oversight for all critical manufacturing and packaging processes.
• Perform QA release and line clearance inspections, AQL checks on product.
• Perform Label Control functions (issuance and reconciliation).
• Perform testing of incoming printed labeling materials
• Conduct review of batch records.
• Perform sampling of the Purified Water System
• Identify deviations and ensure investigations are initiated by the appropriate personnel.
• Clearly communicate complex issues to Management personnel.
• Support creation / revision of SOPs to reflect current practices.
• Assist with FDA and other regulatory inspections.
• Perform all activities in compliance with Osmotica Quality System, site environmental, health and safety rules; and applicable FDA and international regulations.
• Maintain knowledge of current regulatory requirements pertaining to drug product manufacture.
• Perform additional duties and responsibilities as assigned.

Core Competencies

• Position requires the ability to work independently and effectively in all areas of communication, collaboration, and decision-making.
• Great attention to detail with ability to work on multiple projects.
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency.
• Collaborate with Production, Warehouse and other QA team members as partners.
• Computer experience required; Proficiency in Microsoft Office (Word, Excel).

Experience and Qualifications

• High School Diploma or equivalent or technical school certificate.
• Two years of experience in, or support of, pharmaceutical or biotech GMP manufacturing.
• Proficient knowledge of a GMP production facility, manufacturing processes, and/or inspection processes.
• Demonstrated understanding and application of cGMP, current industries practices and relevant guidance.
• Excellent written and verbal communication skills.
• Ability to multi-task effectively.
• Quality Assurance experience a plus.