Operator I, Non-Aseptic Production
Indivior
16 days ago
On-site
Raleigh, NC
Operations
Operator I, Non-Aseptic Production
Position Overview
- Operate processing and test equipment in environmentally controlled areas per SOPs (e.g., steam sterilizers, formulation tanks, analytical balances, pumps, filter test equipment). Monitor cycles, review data, and complete documentation.
Responsibilities
- Comply with cGMP by following SOPs and Master Batch Record instructions; ensure training is complete for the role/tasks.
- Ensure equipment and work areas are cleaned/maintained; sanitize and clear production lines before/after operations.
- Review raw process data to ensure process standards are met; assess compliance to cycle standards.
- Use sound judgment and attention to detail to prevent issues affecting equipment/product.
- Communicate with Production, QA/QC, Maintenance, and Engineering on manufacturing status and potential quality/compliance concerns.
- Monitor and document production activities (manual and computerized: batch records, logbooks, etc.).
- Maintain a safe work environment; report hazardous conditions.
- Set up/adjust equipment; disassemble/install parts as needed; operate production equipment.
- Receive, check, store, handle, and deliver bulk/finished drug products using proper material handling.
General Duties
- Follow SOPs and documentation procedures; perform additional assigned duties.
Requirements/Qualifications
- High School Diploma required.
- Minimum 1 year experience in a regulated environment OR BioWorks Certificate required.
- Gowning experience in a classified area required.
- Knowledge of cGMPs; basic math/science; computer use.
- Ability to read/interpret/apply technical writing and instruction.
- Good vision; strong verbal/written communication; attention to detail.
- Experience with batch records and pharmaceutical production.
- Mechanical aptitude preferred.
Physical
- Continuous standing/walking; frequent bending/lifting/carrying up to 50 lbs; wear required PPE.
Benefits (as listed)
- Competitive PTO; bonus program eligibility; 401(k) + Profit-Sharing (company match); stock purchase discount; comprehensive medical/dental/vision/life/disability; flex/HSA; tuition reimbursement; adoption assistance; wellness programs and other discounts/perks.
Position Overview
- Operate processing and test equipment in environmentally controlled areas per SOPs (e.g., steam sterilizers, formulation tanks, analytical balances, pumps, filter test equipment). Monitor cycles, review data, and complete documentation.
Responsibilities
- Comply with cGMP by following SOPs and Master Batch Record instructions; ensure training is complete for the role/tasks.
- Ensure equipment and work areas are cleaned/maintained; sanitize and clear production lines before/after operations.
- Review raw process data to ensure process standards are met; assess compliance to cycle standards.
- Use sound judgment and attention to detail to prevent issues affecting equipment/product.
- Communicate with Production, QA/QC, Maintenance, and Engineering on manufacturing status and potential quality/compliance concerns.
- Monitor and document production activities (manual and computerized: batch records, logbooks, etc.).
- Maintain a safe work environment; report hazardous conditions.
- Set up/adjust equipment; disassemble/install parts as needed; operate production equipment.
- Receive, check, store, handle, and deliver bulk/finished drug products using proper material handling.
General Duties
- Follow SOPs and documentation procedures; perform additional assigned duties.
Requirements/Qualifications
- High School Diploma required.
- Minimum 1 year experience in a regulated environment OR BioWorks Certificate required.
- Gowning experience in a classified area required.
- Knowledge of cGMPs; basic math/science; computer use.
- Ability to read/interpret/apply technical writing and instruction.
- Good vision; strong verbal/written communication; attention to detail.
- Experience with batch records and pharmaceutical production.
- Mechanical aptitude preferred.
Physical
- Continuous standing/walking; frequent bending/lifting/carrying up to 50 lbs; wear required PPE.
Benefits (as listed)
- Competitive PTO; bonus program eligibility; 401(k) + Profit-Sharing (company match); stock purchase discount; comprehensive medical/dental/vision/life/disability; flex/HSA; tuition reimbursement; adoption assistance; wellness programs and other discounts/perks.