Quality Technician II, Aseptic Control
RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit www.resilience.com
Autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.
- Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
- Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
- Complete required training.
- Perform visual inspections.
- Use MODA to collect and analyze samples.
- Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.
- Ensure that others carry out laboratory duties in a manner consistent with cGMP.
- Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
- Perform routine sampling activities and associated data entry.
- Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
- Read and interpret diagrams, drawings, and other schematics.
- Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
- Provide feedback on service and quality issues on a timely basis.
- Basic knowledge of sterile room techniques, chemical handling and usage
- Mechanical/technical aptitude
- Ability to work effectively in a team environment
- Candidate should possess the ability to work in a changing/demanding environment
- High school graduate, vocational school graduate or equivalent
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
- Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.
- Minimum two years of experience in a pharmaceutical production environment
- Working knowledge of MODA, Microsoft applications, SAP, KRONOS, and Trackwise
- Experience working in a LEAN manufacturing environment
- Knowledge of cGMPs and FDA policies/procedures