Analyst, Quality 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 Position Summary: The Analyst, QC Aseptic Control (Night Shift) is responsible for reviewing sampling and laboratory data and autonomously performing 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 Grade A aseptic environment and in a laboratory setting, and includes the maintaining of gowning qualification. This is a Night Shift position - 12-hour rotating schedule from 6pm - 6:30am (2 days on /2 days off /3 days on)
Requirements
- General experience in a pharmaceutical production or quality control environment (GMP/GDP)
- Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
- Good attention to detail is required. Must be capable of keeping accurate records and performing mathematical calculations
Nice To Haves
- Bachelor's degree, scientific discipline
- Significant experience in a sterile or cGXP environment
- Lab experience is a plus
Responsibilities
- Supports coordination of workflow for Environmental Monitoring team.
- Verifies QC data, while monitoring for trends and abnormalities.
- Performs project work and leads laboratory investigations.
- Trained and able to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed.
- Review completed production documentation (for example: logbooks) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance.
- Troubleshoots methods and processes.
- Train others on systems, software, equipment, machines, procedures, and/or processes.
- Answer compliance and process questions from others.
- Communicate policies and procedures to employees.
- Fill in for Analyst II/Team Lead when absent.
- Gather, organize, and communicate operational information to others.
- Lead and coordinate investigations and studies with little supervision.
- Lead process improvement activities and teams to meet strategic goals.
- Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned.
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
Industry
Professional, Scientific, and Technical Services
Number of Employees
501-1,000 employees
