Job Summary: The Manufacturing & Warehouse Associate is responsible for producing various media products, including sterile cell culture media, reagents, and other solutions. This role involves performing aseptic operations and ensuring the proper filling and packaging of finished products within a clean room environment. Key Responsibilities:
- Conduct aseptic operations both inside and outside of clean room environments.
- Execute clean room sterile operations, including washing and sterilizing equipment and materials in accordance with Standard Operating Procedures (SOPs).
- Utilize autoclaves and dry heat ovens for the sterilization of production items.
- Assist with the changeover of manufacturing equipment as specified.
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validations as required.
- Rotate through various pre and post-filling positions (e.g., prepping materials, packing, labeling, rework, bagging) based on production needs.
- Perform torque and fill checks as specified for bottle runs.
- Maintain cleanliness and housekeeping standards in all manufacturing areas.
- Achieve qualification in one or more designated processes and operations per the current Training Matrix.
- Document all activities within batch records following current Good Documentation Practices (cGMP).
- Assist in training new employees on manufacturing operations and tasks.
- Perform basic PeopleSoft functions as required.
- Contribute to continuous improvement initiatives (iKaizen, Safety, Lean, etc.).
Working Conditions:
- May work in clean room and other regulated areas.
- Regular exposure to automated equipment lines, including associated noise and vibration.
- Required to stand for extended periods and frequently lift/move items (up to 25 lbs).
- Personal Protective Equipment (PPE) must be worn as required, including gowning, safety glasses, nitrile gloves, and masks.
Required Qualifications:
- High School Diploma or GED.
Preferred Qualifications:
- Experience in a manufacturing or warehouse environment is a plus.
Certifications:
- Relevant certifications in manufacturing or aseptic processing are beneficial but not required.
Education: High School