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BioSpace

BioSpace is hiring: Analyst, Quality Control (Night Shift) in Olde West Chester

BioSpace, Olde West Chester, OH, United States

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Overview

Join to apply for the Analyst, Quality Control (Night Shift) role at BioSpace.

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.

Schedule

  • This is a Night Shift position - 12-hour rotating schedule from 6pm - 6:30am (2 days on /2 days off /3 days on)

Position 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 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.

Minimum Qualifications

  • 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

Preferred Qualifications

  • Bachelor’s degree, scientific discipline
  • Significant experience in a sterile or cGXP environment
  • Lab experience is a plus

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or other non-job-related characteristics or grounds specified in applicable laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

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 designed to support our employees with healthcare, family building benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement and caregiving support. Base pay range for this position is $24.00 - $34.50 per hour, dependent on location and experience. Excited about Resilience and the biomanufacturing revolution? Apply and start a conversation with a recruiter.

Location & Job Type

  • Location: West Chester, OH
  • Employment type: Full-time

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