Job Scope
Execute production, production support processes, and in-process quality control checks according to standard operation procedures. Maintain working knowledge of cGMP requirements to ensure adherence to company policies and procedures. Set up and operates production equipment in clean room and non-clean room environments to produce work in process and finished components.
Key Duties and Responsibilities
* Perform work in a safe manner consistent with DiaSorin's health, safety, and environmental policies and assume responsibility for personal safety and that of co-workers to result in a safe work environment for all employees and the protection of the environment and the community at large.
* Follow DiaSorin's established procedures for the safe handling and disposal of hazardous, radioactive, and infectious material.
* Participate in DiaSorin's safety training programs and demonstrate competency in the use of Material Safety Data Sheets, Chemical labeling, corporate emergency response procedures, and DiaSorin's Health, Safety, and Environmental policies.
* Be aware of and understand the hazards specific to your area and follow appropriate safety precautions necessary to control them.
* Accurately and neatly complete filling documentation in batch records, forms, and other cGMP documents.
* Clean, prepare, set-up, and operate production equipment for processing operations.
* Operate production equipment in clean room and non-clean room environment.
* Perform in-process quality checks for specific quality attributes (fill check, torque check and label check, etc.). Inspect product for defects and conformance to quality standards.
* Clean work area and production equipment. Decontaminate work surfaces in accordance with defined procedures.
Education, Experience and Qualifications
* A minimum of a High School diploma or equivalent is required.
* Associates degree in related field is desired.
* Minimum 1 year manufacturing experience in related field.
* Manufacturing experience, preferably with liquid filing, in IVD (In Vitro Diagnostics) / Device / Pharmaceutical industry and/or highly regulated FDA environments and biotechnology / medical device fields.
* Experience using basic laboratory equipment to complete production and filling activities including mixers, pipettes, and scales.
* Experience with automated filling equipment and lyophilization equipment preferred.
* Ability to add, subtract, multiply and divide all units of measure, using whole numbers, common fractions, and decimals
* Mechanical aptitude and troubleshooting skills
* Experience working with Microsoft Office (MS Word, MS Excel), Google Products, and other web based systems
* Good written communication skills, analytical capability, and ability to grasp complex concepts.
* Attention to detail
* Demonstrated competence in reading and completing charts, forms, and other documents
Whatweoffer
Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.