Analyst, Quality Control

Posted 13 Days Ago
Be an Early Applicant
West Chester, OH
In-Office
24-35 Hourly
Junior
Healthtech • Pharmaceutical • Manufacturing
The Role
The Analyst, QC Aseptic Control reviews sampling data and performs tasks for environmental monitoring in a sterile manufacturing site, ensuring cGMP compliance.
Summary Generated by Built In

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 Analyst, QC Aseptic Control 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 Monday - Friday Day shift position.

Position Responsibilities:

  • Supports coordination of workflow for Environmental Monitoring team.

  • Verifies QC data, while monitoring for trends and abnormalities.

  • 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.

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

Sponsorship or support for work authorization, including visas, is not available for this position.

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 characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local 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 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. Our target base pay hiring range for this position is $24.00 - $34.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Top Skills

Cgmp
Environmental Monitoring
Gdp
Gmp
Mathematical Calculations
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The Company
Boston, Massachusetts
1,597 Employees
Year Founded: 2020

What We Do

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale

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