Manufacturing Associate Level 1

Job Title: Manufacturing Associate Level 1
Job id : # 26-05255
Location: Walkersville, MD , 21793
Duration: 06 Months

Shift begins at 7:30AM for a daily meeting, and will end at 4PM, Monday through Friday.

Summary

• Responsible for participating in upstream and/or downstream aseptic manufacturing of LAL products in a ISO 5 environment according to company and departmental SOPs. Performs set-up and operate production equipment in the LAL Filling and Finishing areas. Performs product inspections and final kit packaging of finished goods.

• Operating in a safe work culture (safety chats, safety and EPS observations, 6S)
• Completion of LAL Cleanroom General Training
• Aseptic processing/gowning
• Cleanroom Equipment Set-Up and Usage
• Environmental Monitoring
• Qualification of SAP Transactions (COR3, COR6, MIGO, LS26)
• Completion of LAL Finishing General Training
• Finishing Equipment Set-Up and Usage
• Qualification of SAP Transactions (COR2, COR6, MIGO, MB1A, LB01, LS26)
• GMP Documentation practices
• Product Sample Submission
• Inspection Proficiency Testing
• Inspection Process
• Component Kitting Process
• Continuous Improvement Projects
• Perform job functions with minimal operator related PRs
• Perform aseptic processing with minimal operator related personnel excursions (EM)
• Understand basic level of LAL process flow
• Achieve yearly personnel utilization target
• Maintain training compliance to meet yearly target
• Must be able to demonstrate GMP documentation practices (minimal document errors)
• Must be able to follow standard operating procedures and complete production records
• Understand compliance in the execution of GMPs in a manufacturing environment
• Comply with all safety policies and general regulations
• Perform other duties as assigned.

• Degree (preferred) : Associates, Field of Study Science

• Quality : Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
• Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.

The hourly rate for this position is between $25.00 and $26 per hour.

Compensation:
Factors that may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate].

Benefits:
Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com