This role is on a fixed (non rotational) morning shift pattern from 7:00am to 3:30pm, Monday to Friday.
It is primarily lab-based and involves working in a controlled environment in line with established procedures and quality standards.
Responsibilities
Performs in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GDP) for commercial product in a timely manner.
Perform in-process product inspection and testing for commercial products as conforming to specified requirements in accordance with product specification and quality assurance standards; prepares, records, and updates inspection report form.
Execute transactions related to Lot Release in a defined system.
Collaborate with Quality Engineers, Manufacturing, Process Engineers and other functions on any issues that arise in relation to the Lot Release process.
Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.
Monitor equipment and instrumentation to ensure there are no issues and equipment is clean and safe to use.
Ensure all documentation and labelling is legible, complete, and correct per current Good Manufacturing Practices.
Assist in setting up the Lot Release Department and associated Lot Release Lab.
Assist in carrying out Technical Method Validation (TMV) and troubleshooting test methods.
Initiate and assist with the Nonconforming Material Review (NCMR) process during manufacturing of commercial products.
Perform functional tests in a lab environment, with familiarity using microscope and similar equipment.
Adhere to all GMP, safety guidelines and company standards at all times.
Assume and perform other duties as assigned.
Qualifications
Minimum Level 6 in Quality, Engineering or a related discipline.
4–6years of experience within the medical device industry.
Strong interpersonal and teamwork skills; excellent written and verbal communication skills.
Ability to flex to work in different shifts to meet demand.
Proficiency with statistical analysis (e.g., Minitab) and Microsoft Office Products (Word, Excel, Outlook) is desirable.
Benefits
Front-row seat to life-changing CGM technology.
Full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
Exciting and innovative, industry-leading organization committed to employees, customers and the communities served.
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