Job Description
Sr. Quality Control Technician needed!
Position Summary:
The Senior Quality Control Technician will provide an independent review of materials and documentation, supplied by both internal manufacturing and external suppliers, to determine material acceptability. The Senior Quality Control Technician will also assist Quality Engineers with data gathering/analysis and QMS maintenance.
Essential Duties and Responsibilities:
- Work inside a laboratory environment. Ensure cleanliness of QC areas and properly handle materials.
- Perform lot release testing, record data on data sheets and able to summarize, analyze, and perform basic statistical analysis on results when required.
- Perform receiving inspection activities on incoming materials which can include: confirming specifications, performing visual examination and taking variable measurements, and rejecting and returning unacceptable materials.
- Provide independent, secondary review of fellow Technician’s work.
- Assemble sample product as needed for testing purposes.
- Document inspection results by completing reports, logs, and inputting data into databases.
- Monitor incoming product quality and report observations upward to Quality Engineering and/or Quality Management.
- Maintain measurement equipment in an operable state by following setup procedure and monitoring calibration status.
- Generate NCR/Deviation Reports.
- Participate in Quality System Improvements through the CAPA process, either as a CAPA owner or contributor.
- Think critically and proactively suggest activities for continuous improvement as opportunities arise during the course of daily work. Propose procedures modifications as appropriate and submit for approval.
- Interface with suppliers regarding lot release and related issues.
- Collaborate with engineers on developing new and modifying existing lab procedures/methods for inspecting and evaluating product.
- Facilitate data and information collection for use in monthly/quarterly/annual performance metrics.
- Develop and lead training exercises commensurate with area(s) of functional expertise.
- Support internal and external audit activities as assigned by manager.
- Support Internal Manufacturing activities.
- Provide leadership/mentorship to other members of the QC team, including training of new team members during onboarding.
- Comply with all applicable company policies and procedures and maintain current training on these records.
- Other activities as assigned by departmental management.
Educational Requirements:
- Minimum high school education.
- Two years vocational technical training or eight years applicable experience and knowledge preferred.
Years of Experience:
- Eight years of experience working in a quality control role with ISO and GMP systems and requirements.
Other Skills and Abilities:
- Problem-solver with the ability to exercise sound judgment under challenging circumstances.
- Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.
- Ability to interface with technical services, R&D, manufacturing, and regulatory affairs to accomplish required tasks.
- Ability to communicate with co-workers and all levels of management in a professional manner.
- Familiarity with Microsoft Excel and Minitab and/or other spreadsheet/database software for compilation/trending of data.
- Knowledge of GXP, 21CFR, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance
- Possess strong character with self-confidence and integrity necessary to ensure that the patient safety and customer satisfaction are always of utmost importance.
- Strong background in a manufacturing and operations environment
- Sound technical background and the ability to educate stakeholders, management and customers pertaining to quality assurance/control principles and techniques.
- Ability to interface with internal customers at all levels and 3rd-party partners.
- Light mechanical duties: intermittent stress due to changing priorities and a variety of tasks that need to be completed in a timely manner.
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