1. JOB SUMMARY

The Quality Engineer provides functional and strategic support to in-house and CMO teams to ensure consistent implementation of quality concepts especially those associated with drug developmental programs and ensures the successful and timely release of GMP process development products/supplies and GMP clinical supplies by providing quality direction on manufacturing options, capabilities, and providing quality oversight of the overall manufacturing and testing process.

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Maintain relationships with vendors, contractors, and consultants to ensure effective execution of assigned drag development tasks per phase appropriate guide.
• Liaise with suppliers in addressing nonconformities through thorough investigations.  Assess and determine appropriateness of corrective/preventive actions to avoid recurrence
• Contribute to risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Product User Risk Analysis, Risk Benefit Analysis and Risk Management Report
• Promote a GxP and Quality mindset at all levels within the aspects of a development organization
• Partner with the project teams charged with the delivery of the pipeline projects ensuring that combination product (drug and device) and broader quality considerations are an intrinsic part of project delivery
• Act as a company authority for the interpretation of GxP regulations and guidance documents
• Support both process and equipment IQ/OQ/PQ validation activities.
• Support Internal/external Audit. Able to record Audit observations and prepare and/or review written QA reports for audits and inspections.
• Develop and maintain tracking reports, scorecards, and other tools to monitor quality
• Manage and oversee responses and CAPAs in response to audits.
• Assists in the investigation and writing of non-conformances such as deviations, complaints, OOS, OOT, deviations, etc.
• Perform statistical analysis using statistical software like Minitab
• Responsible for identifying defects and have the authority to report device defects at any time

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Minimum of 3-5 years of Quality Engineering, product development and/or process engineering experience
• BS degree preferred in Science or engineering
• 1-3 years minimal of GMP experience working within ISO 13485 and/or FDA 21CFR Part 820 and FDA 21 CFR Part 210 and 211 environments
• 1-2 years of equipment and process validation (IQ/OQ/PQ) experience
• Knowledge of ICH guidelines preferred
• Ability to interpret equipment specifications (ex: URS, CAD Drawings) and Piping/Instrumentation Diagrams (PID) preferred
• Experience in working in a project team environment
• Be able to handle multiple projects

4.  PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.