The Quality Engineering Support Specialist provides quality engineering support to raw material and supplier qualification activities and serves as a key quality resource for manufacturing and packaging operations. This position works closely with the ARx Planner and Supervisor, Packaging Operations, Quality Assurance, and other cross-functional teams to support the investigation, planning, implementation, and continuous improvement of processes, products, and packaging operations.

The Quality Engineering Support Specialist is responsible for identifying and addressing opportunities that directly impact product safety, quality, regulatory compliance, operational efficiency, and productivity. The position applies quality engineering principles, risk-based approaches, data analysis, and problem-solving methodologies to support robust and compliant pharmaceutical manufacturing processes.

Essential Functions:
• Assists in developing modified and new processes for quality systems related to producing specialized drug delivery therapeutic products. Works in close collaboration on cross functional teams with Packaging, Operations, Engineering and Clients to accomplish successful outcomes.
• Performs a variety of engineering tasks, which include but are not limited to the review of developmental and validation protocols and leads the execution thereof in the packaging areas in compliance with 21CFR 211 Regulatory standards. Supports cleaning verification, validation, and re-validation efforts.
• Provides quality engineering support for the raw material qualification and supplier qualification processes, including evaluation of supplier documentation and questionnaires, material requirements, specifications, and quality related documentation.
• Perform internal and external audits, as applicable.
• Collaborates with Supply Chain, Purchasing, Quality Assurance, Manufacturing to support the qualification and ongoing monitoring of raw materials and suppliers.
• Maintains frequent and effective communication with the ARx Planner and Supervisors to support daily manufacturing activities, resolve quality related issues and ensure timely completion of raw material and component releases.
• Supports the development, revision, and implementation of SOP's, specifications, forms, and other controlled documents related to quality engineering activities.
• Coordinates and supports packaging operations including planning and execution of quality sampling, in-process quality inspection during developmental, GMP and commercial packaging production.
• Completes Acceptable Quality Limit (AQL) inspection and evaluates samples for defects and classify findings in accordance with established critical, major, and minor defect criteria, as applicable.
• Investigates product, raw material and packaging issues and non-conformances using appropriate root cause analysis and problem-solving methodologies.
• Participates in and/or lead change control activities, including assessment of proposed changes, determination of quality and regulatory impacts, and development of implementation requirements.
• Possesses strong technical writing skills and engages in deviation investigations for commercial production.
• Provides quality engineering support for the receipt, inspection, sampling, testing, review, and release of raw materials intended for GMP manufacturing and packaging operations.
• Coordinate and/or perform activities associated with the receipt of raw materials, including verification of material identity, quantity, labeling, container integrity, supplier documentation, and applicable receiving requirements.
• Participates in completion of supplier scorecards by providing supplier performance input, working closely with purchasing functions and developing continuous improvement objectives for suppliers.
• Assists and/or executes Supplier Corrective Action Requests (SCAR's) and follows up through completion.
• Ensures all quality engineering activities are conducted in a safe, responsible and professional manner consistent with all accordance with applicable GMP requirements, Company Policies, Quality Systems Requirements and Relevant Regulatory Standards (e.g. 21CFR211).
• Promote a culture of continuous improvement, quality ownership, regulatory compliance, and proactive risk management.
• Proficiently employs current software tools for communications, presentations, engineering, project tracking and statistical analysis (e-mail; spreadsheets; PowerPoint, Project Management, Experimental Design, Statistical tools, etc.).
• Maintains awareness of business strategies and plans; aligns day-to-day program support activities with same.
• Provide technical oversight and direction to Operation's associates during production of developmental, scale up and validation trials for packaging operations. Monitor production floor processes for conformance to GMP's, established SOP's, batch records and regulatory requirements per 21CFR 210 and 211.
• Champion a right-first-time approach by promoting quality at every stage of the process and supporting continuous quality improvement initiatives.

Additional Responsibilities:
• Networks across functions to meet business objectives. Proactively shares technology inside the company and shares information responsibly with external contacts.
• Provide technical support to internal and external customers on process and equipment capabilities and quality issues. Conducts deviation investigations as assigned; develops and implements preventative actions.
• Participates in training and assists with training, where applicable.
• Performs other duties and responsibilities as assigned.

Job Specifications:
• Requires Bachelor's degree in an Engineering (Chemical preferred), Pharmaceutical Sciencesor other Technical discipline coupled with relevant expertise.
• Two (2) years minimum experience in pharmaceutical manufacturing, quality, engineering, or regulated cGMP manufacturing environment.
• Training and/or experience in cGMP and FDA protocols, cleaning validation and process validation; preferably also have experience design control, statistically based experimental design (DOE), statistical analysis, Quality-By-Design (QBD), Process Analytical Technology

(PAT), Risk Analysis and LEAN manufacturing.
• Strong attention to detail and ability to make sound, risk-based quality decisions.
• Excel, Word, PowerPoint, Outlook, Statistical software package proficiency.
• Ability to effectively organize thoughts, information and data; can articulate and convey them (oral and written) concisely and clearly to others.
• Ability to effectively prioritize workload and effectively leads multiple tasks and projects simultaneously.
• Time flexibility to occasionally work extended hours and/or different shifts as programs and business demands. Must be able to travel as needed to support the business (<25%).
• Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, chemical irritants; may be required to use personal protective equipment such as masks, uniforms, blues, hairnets, gloves, safety glasses/goggles, shields, etc.
• Ability to work both independently and function effectively in a team environment setting.