Quality Engineer

Incorporated in 1998, CutisPharma's FIRST® Unit-of-Use Kits franchise has grown in its 17 years of operation from two product offerings to 24 different products with extensive usage across all national pharmacy chains, independent pharmacies, and hospital inpatient/outpatient pharmacies. In 2014, we significantly expanded our operating infrastructure and capabilities with a move into a new state-of-the-art corporate headquarters that includes facilities for warehousing, distribution and manufact

The Quality Engineer will primarily be responsible for evaluating and assist in developing, as necessary, all quality characteristics of the plant facilities, validation and qualification activities, and equipment quality system (critical systems). The Quality Engineer will execute and/or coordinate risk and gap assessment analysis to ensure that the plant critical systems and equipment are in a state of control. The experience candidate will proactively participate in facilities and equipment quality system enhancement projects to decrease the likelihood of action(s) resulting from a regulatory inspection; and will work in partnership with manufacturing operations, research and development, engineering, maintenance and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.

* Evaluate facilities and equipment quality system. Quality evaluation of the plant critical systems. * Approve engineering change control for validated critical equipment and controlled areas which includes preapproving and approving of change controls. * Provides quality oversight for process equipment qualification and commissioning, and facility commissioning and validation. Approves protocols/validations/qualifications. * Analyzes data and assist in implementation of both corrective and preventative actions to enhance processes for critical systems and equipment (water, HVAC, powder filling equipment, capper, labeler, etc.). * Leads and/or coordinates investigations related to critical systems and equipment. CAPA management and root cause analysis. * Assist in gap analysis, FMEA and/or risk assessments to ensure evaluation of critical systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc. * Interacts with the regulatory officials to convey the compliance level of the facilities and equipment quality system during regulatory inspections. * Participates in quality projects and teams to implement improvements to the facilities and equipment quality system infrastructure to meet regulatory requirements. * Provides training to appropriate personnel related to facilities and equipment quality system * Trends and tracks critical system data as appropriate. * Provides support to the plant during maintenance activities. * Perform other tasks on projects as needed/assigned.

* B.S. Degree in engineering or technical science degree. * Minimum 5 years QA experience in pharmaceutical or other highly regulated industry. * Working knowledge of cGMP practices. * Working knowledge of 21 CFR Part 210, 211 and USP, ISPE trends and guidelines. * Must have experience in qualification and validation practices. * Requires approximately 10% travel. * Ability to work in a team environment. * We recognize hard work and dedication with benefit offerings that address individual needs. **Our comprehensive package of benefits for eligible employees includes the following:** * Competitive compensation package as well as bonus incentives for excellent performance * Competitive medical, dental and vision insurance * Paid time-off program, Vacation * Tax-advantaged savings plans [401(k) with match and deferred savings plans] * Company-paid life insurance * Anniversary Service Award program