Senior Quality Assurance Specialist

5 days ago

Hopkins, Minnesota, United States Manpower Engineering Full time

Manpower Engineering is seeking a highly skilled Senior Quality Control Technician to join their team. As a key member of the quality assurance department, you will be responsible for ensuring that all products meet the highest standards of quality and safety.

Job Description:

We are looking for a professional with a strong background in quality control who can work effectively in a laboratory environment. The ideal candidate will have experience working with ISO and GMP systems and requirements, as well as excellent communication skills.

Responsibilities:

  • Perform lot release testing, recording data on data sheets, and providing basic statistical analysis on results
  • Perform receiving inspection activities on incoming materials, confirming specifications, performing visual examination, and taking variable measurements
  • 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 as a contributor
  • Work inside a laboratory environment, ensuring cleanliness of QC areas, and properly handling materials
  • Think critically and proactively suggest activities for continuous improvement as opportunities arise during the course of daily work
  • Propose procedure modifications as appropriate and submit for approval
  • Collaborate with engineers on developing new and modifying existing lab procedures/methods for inspecting and evaluating product
  • Support internal and external audit activities as assigned by manager
  • Support Internal Manufacturing activities
  • Comply with all applicable company policies and procedures and maintain current training on these records
  • Other activities as assigned by departmental management

Requirements:

  • 4-6 years of experience working in a quality control role with ISO and GMP systems and requirements
  • 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

Estimated Salary: $35 per hour, based on the job description and location

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