CEL - Quality Control
Quality Control Technician
Job Number: 21-05391
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Control Technician for our client in Warren, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The QC Technician is responsible for supporting Quality Control testing for release of clinical products.
- This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.
- Additionally, this position will participate in supporting document management, projects, CAPAs and investigations in accordance with the organizations policies, procedures and state, federal and local laws and compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times.
- Performs routine laboratory activities.
- Utilize scientific principles to assist in laboratory testing methods and the proper use of laboratory equipment.
- Understands regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
- Work and communicate effectively within the team to ensure timelines are met.
- Review data in accordance with applicable procedures and cGMP requirements.
- Perform assigned tasks and track timelines within a CAPA, deviation, or project.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
- Performs other tasks as assigned.
- Assists with developing best practices in the laboratory.
- Use technical expertise to troubleshoot and solve problems that may come up in the day to day operation of the department.
- Capable of handling complex issues and solving problems with minimal guidance.
- Hands on experience with various laboratory techniques and environmental monitoring.
- Ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Problem solving ability/mentality, technically adept and logical.
- Ability to work with management locally and globally.
- Follow directions well; work cooperatively as a team leader, an individual contributor and as a team member.
- Advanced written and verbal communication skills.
- Ability to work under limited supervision.
- Communicates effectively with peers, management and cross-functionally across the site.
- Critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments.
- Ability to deal appropriately with regulatory agencies and act as a Subject Matter Expert (SME) for the department during regulatory and non-regulatory inspections
- Bachelor's degree, particularly in a Science related field, required.
- 0-3 years relevant work experience required, preferably in a manufacturing environment with cGMP requirement.
- An equivalent combination of education / experience may substitute.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.