Quality Control AnalystInsight Global • Malvern, PA, United States
Quality Control Analyst
Insight Global • Malvern, PA, United States
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Minimum two (2) years of relevant work experience Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratoryor equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs) Must have experience in the following : qPCR, cell culture, Flow Cytometry, and / or ELISA Ability to read / interpret technical documents such as SOPs, work instructions, test methods and protocols Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint) Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical and commercial drug product / drug substance samples Perform peer reviews and approvals of laboratory data Use electronic systems (LIMS, MES, Empower, etc.) for execution and documentation of laboratory data Support of New Product Initiatives (NPI) in groups of 3-6 analysts Perform Instrument Calibration and / or Preventative Maintenance, as needed Update CRS-owned documents using the Electronic Document Management System (EDMS) Order / receive supplies and manage inventory Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight Complete invalid assay and general laboratory investigation records Complete corrective and preventative actions (CAPA) as assigned Assist in the execution of internal audits
Compensation & Details :
- 2 Openings
- Fully onsite role in Malvern, PA - in the laboratory
- $35-39 / hr - exact rate is based on several factors, including skills, experience, and education.
- Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law
- 10 PTO Days & 6 Sick Days
- 12 month extending contract
Requirements :
Day to Day : The QC CRS Analyst is responsible for conducting biochemical and testing of drug substance, final product release and characterization samples, and critical reagent qualifications of cell and gene therapy products, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 10 – 15 other Analysts within a functional Clinical Release and Stability (CRS) Laboratory and report to one of two QC CRS Supervisors. Key Responsibilities :
[job_alerts.create_a_job]
Quality Control Analyst • Malvern, PA, United States
[internal_linking.similar_jobs]
Drug Plastics is a competitive, growing company that wants people who are eager to share their knowledge, talent, and experiences.
We are the premier manufacturer of bottles and closures for medicin...[show_more]
With Staff Management | SMX, you'll get a weekly paycheck, learn new skills, meet new people, and work with a great management team in a clean and safe environment.
Looking for a new opportunity? St...[show_more]
As a Field Technician at Lewis Environmental, you will play a critical role in delivering high-quality service across our four primary service lines : .
This position offers you the opportunity to wor...[show_more]
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.
We guarantee 15-25 hours per week with an hourly pay of bet...[show_more]
Laboratory Application Specialist-Large Molecule.CRO / Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China.
Our core competencies include dru...[show_more]
We are seeking a detail-oriented and experienced.Shift , 2nd Shift , or 3rd Shift QC Inspector.The ideal candidate will play a crucial role in ensuring that our products meet the highest quality st...[show_more]
Remote locations will be considered.Customer Service Business Analyst and Training Lead.The Customer Service Business Analyst & Training Lead plays a key role in strengthening operational excellenc...[show_more]
We are seeking a dedicated and detail-oriented.FSQA (Food Safety & Quality Assurance) Lead.This is a full-time, onsite position ideal for someone passionate about ensuring compliance with regul...[show_more]
Full-Time | On-site | Some Weekend Availability.Why Join the Acero Precision Team?.Acero Precision, located in West Chester, PA is an industry leading Medical Device contract manufacturer producing...[show_more]
Focuses on the administrative and reporting aspects of the company's quality assurance program, including managing records, analyzing data, and dispositioning quality issues under supervision.Is al...[show_more]
Join PAAL — where the community is our classroom.The PAAL Program is a dynamic, community-based organization serving individuals across the autism spectrum.
We blend clinical precision with co...[show_more]![Quality Control Specialist [Temp to Perm]](https://cdn-logos.talent.com/v1/logo/image?feedcode=ziprecruiter-test-p&company_name=Castle%20Creek%20Biosciences%20LLC)
Multiple positions available : ELISA, PCR.Perform testing in support of product manufacturing, employing manual and automated analytical equipment.
Provide direct support of Quality Control analytica...[show_more]
Laboratory profession with focus in Cytotechnologist (Laboratory) for a 13 week contract in the West Chester, PA area.Concentric is a premier staffing firm dedicated to matching outstanding talent ...[show_more]
Earn up to $16 USD / hourly and work remotely and flexibly.Outlier, a platform owned and operated by Scale AI, is looking for.
If you're passionate about improving models and excited by the future of ...[show_more]
At Cloudera, we empower people to transform complex data into clear and actionable insights.With as much data under management as the hyperscalers, we're the preferred data partner for the top comp...[show_more]
Submit your CV and any additional required information after you have read this description by clicking on the application button.
We are always looking for the best, most qualified people to join o...[show_more]
The Eastwood Company is seeking a Quality Control Engineering Technician to play a vital role in delivering Eastwood’s exceptional customer experience by testing and repairing products throug...[show_more]
Kinetic provides high-speed broadband Internet, phone service, and Digital TV packages to residential customers as well as products and services for small, medium, and large businesses, and governm...[show_more]
Quality Control Analyst
Drug Plastics and Glass Co. Inc. • Boyertown, PA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Entry Level Quality Tester
Staff Management | SMX • West Chester, PA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Environmental Laborer
LEWIS ENVIRONMENTAL GROUP • Royersford, PA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Test Products from Home – $25-$45 / hr + Freebies
OCPA • Amity township, Pennsylvania, us
[job_card.part_time] +1
[last_updated.last_updated_30] • [promoted]
Laboratory Application Specialist
Frontage Laboratories • Exton, PA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Control Inspector
Havpak Inc • Malvern, PA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
ZRL Customer Service Business Analyst and Training Lead
Zoetis, Inc • Malvern, PA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
FSQA Lead
LHH US • Malvern, PA, US
[job_card.full_time] +1
[last_updated.last_updated_variable_days] • [promoted]
Quality Control (QC) Roving Inspector
Acero Precision • West Chester, PA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Control Administrator
Applied Energy Systems, Inc. • Malvern, PA, USA
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Board Certified Behavior Analyst
PAAL Program • Downingtown, PA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Control Specialist [Temp to Perm]
Castle Creek Biosciences LLC • Exton, PA, US
[job_card.temporary]
[last_updated.last_updated_30] • [promoted]
Cyto Tech
Concentric • West Chester, PA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Remote Text Quality Evaluator
Outlier • Pottstown, PA, United States
[filters.remote]
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Workday Systems Analyst
Cloudera • Wilmington, DE, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Project Manager
The H&K Group • Douglassville, Pennsylvania, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Control Engineering Technician
The Eastwood Company • Pottstown, PA, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Kinetic Buried Drop Tech
Windstream • Birdsboro, PA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]