Production Specialist - 2nd Shift - Stillwater, United States - USA 2019-003

Job Title

Production Specialist - 2nd Shift

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Stillwater
Home/Office based
Office based

Professional Family: 

  • Operations
Reporting To
Production Supervisor

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2019-003

Job Scope

Your Mission

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.

Main Responsibilities

Your Contributions

• 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

You
Education
High School Certificate
Specialization
Related field
Experience

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.

Technical Competencies
  • 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
Skills

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.

Languages
Fluent spoken and written English
Travel Availability
Not required
Relocation Availability
Domestic USA candidates only eligible to work in the U.S.
Training Required

N/A

Benefits

We Offer You

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).