Summary: The Quality Engineer II is responsible for supporting Engineering Technical Services, Manufacturing, Quality Control and Information Technology teams by ensuring compliance with all applicable laws, regulations, standards and internal procedures across the organization.
Essential Position Responsibilities
- Monitor and continuously improve the Quality System by evaluating supporting documentation to ensure compliance to CGMP, industry standards and other applicable regulations.
- Ability to manage multiple projects and changes in priorities in a fast-paced environment.
- Provide quality engineering oversight on project teams and any necessary support to meet required project deadlines while ensuring compliance to internal SOPs and applicable regulatory guidelines.
- Provide oversight to the Validation Life Cycle through collaboration, review and approval of Commissioning, Qualification and Validation (CQV) efforts for Facilities, Utilities, Computerized Systems and Equipment in biotechnology facilities.
- Review, Approve, and Maintain documentation such as SOPs, Design Documentation, protocols, Periodic Reviews and reports for CQV activities.
- Act as QE lead subject matter expert on cross functional teams to provide input and oversite to validation activities. Lead process improvement initiatives for internal projects related to quality engineering.
- Analyze data from Facilities, Utilities, Systems, Equipment from all areas with emphasis on prioritizing the troubleshooting equipment systems impacting Manufacturing runs.
- Review, provide input and approve Quality Management System records such as Change Control, Deviations, CAPA, support root cause investigations and corrective actions implementation.
- Use theoretical and applied knowledge of utilities, instrumentation, validation and GMP regulations applicable to automated equipment and utility systems.
- Perform quality related data collection/entry/analysis and tracking/trending in support of Quality Engineering and other internal departments.
- Clearly and timely communicate cross functionally within the department and organization and with a high level of professionalism and customer service.
- Other responsibilities, as required by management.
- Motivated, self-starter, excellent problem solver, outstanding communication skills.
- Full time position, which may include after hours and weekend effort as needed.
BS degree required, preferably in a technical field.
5+ years of hands-on experience in Quality Systems.
Direct experience in quality assurance is preferred.
Experience in software, process, cleaning, and equipment validation programs is preferred.
Working knowledge of FDA 21 CFR Part 11 ERES, ALCOA+, and GAMP-5.
Good communication and organization skills.
Must have excellent attention to detail.
- Proficient in Microsoft Office with the ability to input and assess data in other software programs.
|Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender,sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.|
|Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.|
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer