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Analyst, Quality Control (Night Shift)

Analyst, Quality Control (Night Shift)

ResilienceWest Chester, OH, United States
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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 Ni ght 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 (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 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 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.

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Quality Control Analyst • West Chester, OH, United States

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