Responsible for the inspection of completed and packaged BioProcess Containers in a cleanroom environment. QC Inspection personnel are required to follow Standard Operating Procedures, Work Instruction Documents and technical drawings and specifications as they relate to assembled and packaged BioProcess Containers.
This position requires following cGMP (Current Good Manufacturing Practices) and working in a fast paced team environment.
- First Piece Inspection of BPC Assemblies during job set up
- Inspection of BPC Assemblies to drawings, specifications and procedures.
- Enter inspection results in first time quality trending charts.
- Assist production personnel during quality investigations.
- Mentor and train new inspectors as needed.
- Correctly and accurately document inspections in process control documents and inspection forms.
- Two years BPC assembly experience (Preferred)
- Technical expertise of all BPC Assembly Processes (BPC Assembly and LCAM)
- Skilled in reading BPC production drawings
- Accurately follow procedures
- Participate in continuous improvement teams through PPI
- Pass eye test to Purdue Job standards for Group #2 (Inspection and Close Machine Work)
- Ability to identify safety hazards
Non-Negotiable Hiring Criteria:
- HS Diploma or equivalent
- One year BPC assembly experience
Physical and Environmental Requirements:
- Ability to work in a fast paced controlled cleanroom environment up to 8 hours a day with additional overtime as required.
- The Clean-room is controlled a greater than 30% humidity with a temperature between 60⁰ and 70⁰ F.
- The Clean-room has some ambient noise.
- Specific gowning is required including: gloves, hair and beard net and face cover, safety glasses with no makeup / jewelry or piercings.
- Position requires forceful gripping/grasping and repetitive motion including pushing and pulling.
- Ability to use PPE (Personal Protective Equipment) and understand chemical hygiene including labels and SDS 9Safety Data Sheets), common chemicals are disinfectant, solvents and IPA (Isopropyl Alcohol 70% and 99%).
- Must have the ability to inspect containers on a light table for entire shift.
- Must have the ability to stand and move about including reaching, bending, stooping, grasping.
- Must have the ability to use hand tools and equipment including forceful gripping, grasping, pushing, pulling and repetitive motion.
- Must have the ability to frequently lift and manipulate up to 40 pounds unassisted.
This position has not been approved for Relocation Assistance.