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Summary of Position
This role is responsible for supporting the Quality Systems organization through conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.
Essential Functions
- Support and serve as investigator for Out of Specifications results.
- Identify and implement Corrective Actions.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
- Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc.
- Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.
- Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives.
- Generate, execute and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials.
- Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s.
- Maintain current knowledge of US and international regulations regarding Microbiology, Chemistry and cGMP’s.
- Provide support for regulatory agency (i.e. FDA, HC, EU, TGA, etc.) on-site audits.
Requirements
- Bachelor of Science degree in Life Sciences or Engineering required, or equivalent experience.
- Three or more years of relevant experience in a pharmaceutical/medical device manufacturing environment with strong understanding of and exposure to applicable quality systems required.
- Working knowledge of cGMP guidelines and their application in a controlled aseptic environment preferred.
- Must have awareness of quality systems including Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management.
- Must have experience with statistical tools.
- Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
- Must be proficient in use of Microsoft suite office products; Good computer skills, including utilizing personal computers and data entry programs.
- Good hands on, analytical, and problem solving and decision-making skills.
- Excellent writing and verbal communications skills.
- Ability to work independently and with others to accomplish goals and priorities.
- High level of energy and regular, consistent attendance.
LSNJN1451445AJ_1783450025