QC Associate Scientist
QC Associate Scientist
Job Number: 21-12588
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QC Associate Scientist for our client in Summit, 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!
- Responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products for QC Flow Cytometry Department.
- This department is responsible for Flow Cytometry based testing of in process samples, final drug product testing, stability testing, Validation and requalification support, critical reagent testing and qualification, training and other critical support as needed.
- This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.
- Additionally, when needed, this position will be able to assist with training and assay transfer.
- Advanced hands-on experience with various analytical techniques primarily flow cytometry and scientific knowledge in the characterization and transfer of pharmaceutical products.
- Advanced ability to accurately and completely understand, follow, interpret and apply Global
- Regulatory and cGMP requirements.
- Advanced technical writing skills.
- Advanced problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Ability to work with management locally and globally.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers.
- Bachelor's degree required, preferably in Science.
- Advanced Degree preferred.
- 0-3 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Experience working with polychromatic flow cytometry panels and flow cytometry data analysis preferred.
- Perform testing of the in-process, final product, and stability samples.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Capable of handling complex issues and solving problems with only general guidance.
- Prepare and present continuous improvement projects to management.
- Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
- Complete all work in a timely manner.
- Perform peer review of testing data.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Complete all reviews in accordance with required release timelines.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
- Train new analysts to general job duties.
- Complete necessary training to become a qualified trainer.
- Perform training effectively.
- Document training per procedural and cGMP requirements.
- Support document revision, project, CAPA, and investigation/deviation tasks.
- Perform assigned tasks within a CAPA, deviation, or project
- Participate in complex projects and continuous improvement efforts.
- Take a leadership role, as required, for projects.
- Draft and review technical documents, such as SOPs and protocols/reports
- 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.
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:
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.