Danielle Jones

Quality Control Associate/ Specialist- Compliance at Osiris Therapeutics

Location
Baltimore, Maryland Area
Industry
Biotechnology

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Danielle Jones's Overview

Past
  • Quality Control Associate/ Specialist- Compliance at Osiris Therapeutics
  • Quality Control Associate/ Specialist at Osiris Therapeutics, Inc
  • Quality Control Technologist at ITC
  • Quality Control Technologist at ITC
  • Research Associate at Screening Compounds and Logistics Center
  • Early Drug Discovery Associate at Johnson Research and Development
Education
  • Trident University
Connections

62 connections

Danielle Jones' Experience

Quality Control Associate/ Specialist- Compliance

Osiris Therapeutics

Public Company; 51-200 employees; OSIR; Biotechnology industry

June 2008April 2009 (11 months)

Quality Control Associate/ Specialist

Osiris Therapeutics, Inc

Public Company; 51-200 employees; OSIR; Biotechnology industry

June 2008April 2009 (11 months)

Responsible for implementing systems that made quality control department run more efficiently for instance,
monitored with tracking logs and cleared backlog of paperwork for lot release.
Changed with day to day Quality Control Analytic tests per quality standards, this is included but not limited to cell counts, viability and osteogenic differentiation
Responsible for thawing viability and osteogenic samples for cell culture.
Reviewed Batch Production Records which included documentation compiled by Manufacturing, Quality Assurance, and Donor Eligibility groups for purpose of lot release.
Reviewed, organized, directed and approved of all environmental collection records completed by manufacturing during process monitoring.
Responsible for investigating all environmental and out of specification reports associated with product release.
Managed and controlled all incoming Quality Control data from external laboratories.
Responsible for the review and submission of Quality Control Assay Packets to Quality Assurance in a timely matter.
Member of Materials Review Board which made decisions for deviations, corrective actions and preventive actions and investigations to release product.
Preparation and review of all Quality Control testing data trending and reports for senior management used for quarterly and yearly management review.
Reviewed and tested of all incoming raw materials documentation.
Aided in multidosing tissue samples which was cost effective for company’s profit.
Played a role in the technical transition of quality control analytic tests and protocols Allosource and Nuvasive.

Quality Control Technologist

ITC

April 2006August 2007 (1 year 5 months)

Played an essential role for quality control and raw material testing, order product in a timely matter and assisted
In reviewing for lot release.
The HEMOCHRON cuvette testing which is a low blood volume microcoaglulation testing cuvettes. The test array is very broad and includes the fresh whole blood tests for ACT+, ACT-LR (low range), PT and APTT, as well as PT and APTT tests for citrated whole blood.
Finished product testing of ProTime microcoagulation System for prothrombin time testing is designed to safely monitor warfarin therapy.
Quality control instrument testing of microcoagulation systems such as Protime, HEMOCHRON Jr. Signature, signature plus and elite, HEMOCHRON Response, 401, and 801.
Phlebotomy skills.
Understanding of GLP, GMP and quality control principles and practice.
Bioburden.
Reviewing and Releasing of instruments and finished products such as Protime Cuvettes.
People soft experience.

Quality Control Technologist

ITC

20062007 (1 year)

Research Associate

Screening Compounds and Logistics Center

August 2004April 2006 (1 year 9 months)

Operating and validating robotic equipment, Mulitprobe I and II Packard, Tecan, EP3, RTS Thurnall System and Tomtec, pulling compounds from various storage titans, weighing compounds for requestors, sealing and unsealing plates, and manual pipetting.
Solubilization and transferring of compounds for research using the robotic instruments in the drug discovery department.
Preparing and revising SOP’s when necessary in addition to decision making strategies that include recognizing results that may affect quality and accuracy.
Dry down compounds using the Genevac machine then enter compound’s data into the database using Excel2000 Accord program, and then doing submissions of vials.

Early Drug Discovery Associate

Johnson Research and Development

Privately Held; 11-50 employees; Consumer Goods industry

20042006 (2 years)

Danielle Jones' Education

Trident University International

Clinical Research Administration, Master of Science in Health Sciences (MSHS)

20112012

Saint Peter's University

BS, Biology

20002004

Saint Peter’s College

Bachelor of Science, Biology

Trident University

Masters, Clinical Research Administration

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