Quality Technician II, Aseptic Control (Night Shift)
About The Position
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
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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
