AlloSource

Quality Control Analyst II - Essent Biologics

Job ID
2413
# of Openings
1
Work Schedule
Monday-Friday; 8am-5pm
Job Category
Quality Assurance

Overview

As a strategic venture from AlloSource, Essent Biologics is setting a new standard in human-derived biomaterials and 3D biology data for research. The nonprofit biotechnology company provides low passaged primary cells, origin tissue and scaffolds, as well as comprehensive donor and product data to advance regenerative medicine research from benchtop to bedside. Essent Biologics supplies products in small or large volumes and serves as a manufacturing partner by creating master cell banks and an inventory of custom products within a tailored specification. In order to ensure reliable product quality, safety and efficacy, all Essent Biologics products are developed using robust design control processes and produced under current Good Manufacturing Practices (cGMP). For more information, please visit essentbiologics.org.

 

Summary:

As a strategic venture from AlloSource, Essent Biologics realized we had a unique opportunity to recover biological materials from a human source to meet a growing need for the research community. Our decision to develop high quality tissues, cells and scaffolds for research helps fulfill our mission to empower their work. 

 

The Quality Control Analyst II works under general supervision and performs various scientific analyses to evaluate in-process and finished goods, ensuring product compliance with established standards/specifications.  This position conducts and validates various biological and chemical quality control (QC) assays, including but not limited to; flow cytometry, mycoplasma testing, immunomodulation testing, trilineage differentiation testing, microbiological identification and analysis of cell surface markers.  As new products are developed, this position will aid in the development and validation of QC assays for determination of product quality, purity, potency, identity, and safety.

 

Pay:  $59,850 - $72,960/yr based on relevant years of experience.

Bonus:  10% target Bonus Program based on individual and company metrics.

Shift:  Monday-Friday; 8:00am – 5:00pm

Benefits:  Generous Time Off Policy, Paid Sick Leave, 9 paid Holidays, Retirement Plan, onsite Health Care clinic, Wellness Program, Life Insurance, AD&D, Short & Long Term Disability, and more!

Location:  6278 S. Troy Circle, Centennial, CO 80111

 

Essential Duties and Responsibilities:

  • Write and execute analytical/test method validation protocols.
  • Perform the following scientific techniques as needed, but not limited to mammalian cell culture, cell harvest, histology, immunohistochemistry, ELISA, Gram staining, and various biochemical assays such as Pico Green, Metabolic assays, GAG, collagen, or elastin analysis for cellular and matrix content.
  • Ownership, review, and approval of controlled documents pertaining to areas of responsibility.
  • Assist in writing test methods to support transfer to manufacturing.
  • Strong aseptic technique in cleanroom environment and biological safety cabinet.
  • Work with external vendors to maintain lab equipment.
  • Interface and collaborate with R&D and Operations on product Design Control activities and Transfer & Scale Out of processes to manufacturing.
  • Assist area management with Nonconformance/OOS investigations, making comprehensive assessments of risk and product impact.
  • Accurately record QC data and information in accordance with cGxP guidelines.
  • Perform basic data analysis and interpretation of QC results.
  • Interface and collaborate with Engineering to track and trend relevant process data pertaining to areas of responsibility.
  • Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
  • May perform other related duties and responsibilities as assigned.

 

Requirements:

  • Bachelor’s Degree in Science or technical area
  • 3-7 years’ laboratory experience
  • Proficiency in Microsoft Office applications

 

Preferred Experience:

  • Master’s degree in Science or technical area
  • Previous experience at tissue bank, medical device or other FDA regulated industry

 

It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. 

 

For consideration you must apply online, submit a current resume and meet the minimum requirements.  All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position.  AlloSource is a Fair Chance Employer.  Candidates within a 50 mile radius of the hiring zip code may receive first consideration.

 

Equal Opportunity Employer/Veterans/Disability

 

 

AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

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