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 Job Summary The Quality Technician II, Aseptic Control (Night Shift) is responsible for autonomously performing tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. This a Night Shift position working 6pm - 6:30am. 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over again.
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, 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 and/or work instructions
- Perform routine sampling activities and associated data entry
- Wearing 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 issues on a timely basis
Benefits
- Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
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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
