Purpose:
Under direct supervision, performs the filling, packaging, and support in aseptic and non-aseptic clean room environment (Class 100 to 100,000) in accordance with cGMP's (current Good Manufacturing Practices) and other applicable regulatory requirements, such as ISO and OSHA.
Duties & Responsibilities:
- Follow written SOP’s, batch records and work instructions to perform the key silicone forming processes that include:
- Dipping – forming parts from manually dipping a mold core into silicone
- Stripping parts – pulling silicone parts from mold cores without tearing parts
- Texturing – applying texture to silicone parts
- Patching – visually aligning and sealing silicone shells
- Filling – using syringe to precisely fill silicone shells
- Preparation of cleaning solutions for sanitization of facility, equipment, and materials for aseptic and non-aseptic for production use
- Labeling, packaging, inspection of parts and monitoring curing and sterilization processes
- Legibly and accurately record the completion of tasks on routers (and potentially computer or touch screens) or other forms
- Apply attention to detail while performing all assigned tasks - for example: manually forming parts
- Be willing to be trained to perform other duties as needed by production, such as mixing silicone
- Adhere to strict clean room standards: hairnets, no make-up, gloves, gowning, GMP
- Be willing to be trained to use instruments for measurement
- Understand and follow the instructions per applicable routers and guidance documents (QOP, SOP, MOP, etc)
- Maintain hazardous waste according to EH&S procedures
- Other duties as assigned
- Starting job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
Skills & Abilities:
- High school diploma or general education degree required
- Experience in Biotech/Pharmaceutical and cGMP experience and/or training; or equivalent combination of education and experience is preferred
- Prior experience with aseptic processing, and FDA interactions is highly desirable
- Experience with assembly, sanitization, and clean room practices is a must
- Experience in an aseptic clean room class 100 environment a plus
- Able to convert units of measurement, add, subtract multiply and divide
- Ability to multi-task and interact well with others
- Strong interpersonal and communication skills with the ability to communicate effectively at all levels
- Team player with good communication skills and customer focus
- Accuracy and attention to detail
Ability to secure and maintain a favorable background investigation and clearance
Education & Experience:
- High school Diploma or GED equivalent