Kind of contract
Set up & operates production equipment in clean room & non-clean room environments to produce work in process & finished components. Execute production or production-support processes according to standard operating procedures, with a working knowledge of cGMP requirements, to ensure adherence to company policies & procedures.
• 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 including filling, sealing, labeling, lyophilizing, capping.
• 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). Inspect product for defects and conformance to quality standards.
• Clean work area and production equipment. Decontaminates work surfaces in accordance with defined procedures.
• Use of SAP system for performing material transactions, work order completion, quantity reconciliation, and cycle counts.
• Assist in troubleshooting of routine production equipment and processes and notifies engineering and supervisor or issue.
• Actively participates in process improvement projects. Complete ECO, NCR, Deviations, and Risk Assessments.
• Ensure compliance with the Quality Management System, the Company Policies and the Corporate Procedures.
Qualifications Experience Personal Strengths Mobility
Minimum 1 year manufacturing experience in related field.
Minimum of 2-4 years in experience in a cGMP manufacturing field is preferred, but not required.
- Mechanical aptitude & troubleshooting skills
- Experience working with Microsoft Office (MS Word, MS Excel), Google products, & other web based systems
- Good written communication skills are highly desirable
- Attention to detail
- Demonstrates competence in reading & completing charts, forms, & other documents
Manufacturing experience, preferably with liquid filling, in IVD (In Vitro Diagnostics) / Device / Pharmaceutical industry and/or highly regulated FDA environments & biotechnology / medical device fields.
Experience in using basic laboratory equipment to complete production & filling activities including mixers, pipettes & scales. Experience with automated filling equipment & lyophilization equipment preferred.
Ability to read, write & speak English. Add, subtract, multiply & divide in all units of measure, using whole numbers, common fractions, & decimals.
Why people join DiaSorin
- We are known for quality, excellence in customer care and innovative diagnostic products and instrumentation
- We have energy, passion, drive and focus on delivering results because what we do impacts patients each and every day
- We have dedicated and talented employees on our team with an excellent reputation within our industry
- We are active in the communities in which we operate
- We are guided by our strong ethical values
- We are a global company headquartered in Saluggia, Italy with a large presence in North America
- We offer a competitive total rewards package
Others Information as per Local Legal Requirements
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future. It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit https://www.uscis.gov/e-verify EEO is the law. http://bit.ly/2NLB2RJ EEO Supplement http://bit.ly/2CNcC9C (2018).