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Quality Operations Associate II

The Quality Operations Associate II is a critical role on the Quality Leadership Team. This role is responsible for providing tactical and strategic leadership for Quality activities including a strong focus on Manufacturing Quality. Day-to-day activities include coordination with manufacturing, to support the product evaluation and release of Merz North America product. Perform and/or assist with tasks required to oversee the proper operation and monitoring of the manufacturing clean room facility. Oversee and/or assist with tasks related to the activities associated with operation of Merz Quality System and as directed by Quality Operations Management. Works closely with the manufacturing department to investigate issues, identity and implement process improvements to drive quality and cost improvements.
Major duties
Quality Operations
Act as a liaison between the quality and manufacturing departments.
Quality Testing
Support laboratory investigations and implement corrective and preventive actions.
Reduce finished product average cycle time.
Reduce laboratory related errors through method improvements, and effective training.
Support Manufacturing
Support manufacturing needs by ensuring testing for raw materials, finished goods, validation, in-process material and final products is completed accurately, timely and documented correctly.
Quality System Support
Support other Quality System functions as assigned by Quality Management that are related to documentation review
Equipment calibration
Nonconformance review
Out of Specification (OOS)
Corrective and Preventative Actions
Product complaint investigations (if applicable)
Audits
Other tasks as directed.
Quality Operations
Initiate and/or support the development of protocols and final reports for sterilization
Evaluation of new materials or other quality control projects.
Audit Support
Participate with federal, state, and local regulatory officials during regulatory inspections.
Support internal and vendor quality system audits.
Quality System Support
Participate in/support new-hire training and orientation, and on-going training and development of Quality Team.
Education
Bachelor's Degree - Required
BS in Physical Science or Engineering, or Bachelor's Degree in other discipline with equivalent industry experience - Required
Professional experience
GLP/GMP experience - Required
Pharmaceutical/medical Device experience (3 years) - Required
Knowledge, skills and abilities (incl. languages)
Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines - Required
Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, or Validation. Preferred
Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Preferred
Management Systems (LIMS) and Quality Management software is highly preferred. Preferred
Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution. Preferred
Knowledge of methods
Knowledge of rot cause analysis tools, CAPA , NCR investigations - Required
Familiarity with validation requirements Preferred
Familiarity with ISO 8 clean room requirements Preferred
Personal skills
Computer skills including those associated with the word processing, spread sheet programs, databases and statistical analysis.
Ability to prepare testing protocols and reports, operating documents and procedures.
Ability to work with little or no supervision, and make effective decisions.
Other
Some clean room work may be required; no make-up or excessive amounts of jewelry allowed. Lifting of light to moderately heavy (less than 25 pounds) objects. Manual Dexterity.



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