Quality Technician II, Aseptic Control (Night Shift)
About The Position
A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com This position 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. This position 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.
Requirements
- Prior experience in a pharmaceutical production environment
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
- Thorough attention to detail is required
- Must be capable of keeping accurate records and performing mathematical calculations
Nice To Haves
- High school graduate, vocational school graduate, or equivalent
- Working knowledge of MODA, Microsoft applications, SAP, KRONOS
- Experience working in a LEAN manufacturing environment
- Knowledge of cGMPs and FDA policies/procedures
Responsibilities
- 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 (i.e., laboratory notebooks, quality records, and sample receipts)
- Complete required training
- Perform visual inspections
- Use the Environmental Monitoring System 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 24/7 "on-call" support to others
- Provide feedback on service and quality issues on a timely basis
Benefits
- an annual cash bonus program
- a 401(k) plan with a generous company match
- great healthcare (including medical, dental and vision)
- family building benefits
- life and disability insurance
- paid vacation
- paid holidays
- other paid leaves of absence
- tuition reimbursement
- support for caregiving needs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
501-1,000 employees
