API Manufacturing Associate I
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance - effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
- Work in a safe & environmentally responsible manner
- Follow instructions listed in GMP documentation & product quality
- Review SOP's & other documents, as required
- Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
- Manage individual training plan
- Participate in qualification & validation activities as required
- Setup, operate, monitor, & control highly automated processes & systems
- Load & unload product from trucks, tankers & ISO containers, as required
- Execute production schedule to achieve production goals
- Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
- Maintain clean room areas & perform environmental monitoring, as required
- Other accountabilities, as assigned
- High school graduate or equivalent required
- Associate's Degree or higher in Tech, Science, or Engineering preferred
- BioWork or equivalent industrial, military or vocational training combined with experience preferred
- Minimum two (2) years of manufacturing experience in FDA regulated environment preferred
- Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred
- Experience following SOPs to perform tasks & raising issues if errors are found preferred
- Experience following established safety guidelines when performing tasks preferred
- Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required
- Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
- Ability to perform basic material handling tasks, safely & effectively use material handling equipment required
- Ensure compliance with corporate/local SOPs, regulations & ISO standards required
- General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required
- Basic knowledge of biology/chemistry preferred
- Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
- Experience working with work permits/Lock Out Tag Out systems preferred
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