POSITION OBJECTIVE: The Metrology Technician is responsible for ensuring the reliability, accuracy, and precision of quality attribute measuring devices for manufacturing processes, environmental monitoring devices, analytical instrumentation and utilities monitoring devices in a GMP regulated environment.
ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES:
- Completes new and routine scheduled calibrations, performance verifications, and periodic re-validation of facility equipment, devices, and analytical instrumentation to ensure reliable operation and accurate measurement data.
- Ensures timely completion of the required activities and documentation to optimize availability of instrumentation and equipment for use.
- Coordinates third party testing of facilities devices and analytical instrumentation; includes, but not limited to: calibration and/or performance verification services performed on site or off site, new installations, repairs, and resolution of issues in documentation and during testing.
- Records data accurately and completely on required documentation and electronic systems, where applicable.
- Interfaces with electronic calibration and maintenance management system on daily basis to ensure timely completion of scheduled tasks.
- Identification and resolution of out of limit investigations following procedure requirements.
- Assists project teams in obtaining and preparing equipment and instrumentation for execution of company and customer directed analytical and/or manufacturing efforts.
- Supports execution of work related to Equipment/Facility/Utility Qualification documents where calibrations and/or performance verifications and related procedures are required.
- Authors new and revises existing procedures directing the calibration and/or performance verification of devices and analytical instrumentation, where required.
- Assist in the creation of new instrument and equipment documentation and procedures.
- Responsible for promoting and maintaining safe and healthy working conditions in their assigned work area.
- Ensures employees and contractors receive appropriate training and information necessary to conduct their activities in a safe and healthy manner when on-site.
- Provides support for regulatory, internal, and external audits.
- Reads and complies with all company policies, standard operating procedures, and Current Good Manufacturing Practices.
- Contribute to continuous improvement initiatives and projects.
- Assist in other daily activities required of the area as assigned.
- Work will be performed at the manufacturing and laboratory sites located in Dunkirk, NY.
REQUIRED EDUCATION AND QUALIFICATIONS
- Minimum two-year technical degree; equivalent experience will also be considered.
- Minimum of three years of experience in a quality assurance, quality control or pharmaceutical environment with understanding of GMPs, documentation practices, and devices/instruments commonly used in pharmaceutical manufacturing and/or testing processes.
- Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.
- Effective written and verbal communication skills is required across organization levels, with the ability to author documentation utilized by a broad range of disciplines, read and comprehend SOPs, vendor documentation, and other written documentation, and basic understanding of statistical mathematics.
- Ability to write reports with excellent attention to detail and planning.
- Ability to manage multiple tasks, prepare metrics and meet deadlines.
- Proficiency with current software applications, such as, Office (e.g., Word, Excel, etc.) is required and proficiency in statistical software applications is preferred.
- Knowledge and experience with electronic quality management and computerized calibration and maintenance management systems preferred.
- Must be available for off hour and weekend hours for special projects, pre-planned as needed.
- Able to lift up to 25 lbs.
- Must have a valid drivers license.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.