QC Specialist I

Medisca•Irving, TX

5d•Onsite

About The Position

A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people. The QC Specialist I will be responsible for the daily review of both routine testing data as well as stability data. They will ensure Certificates of Analysis are submitted to the customer in a timely manner. They have the ability to participate in investigations, deviations, change controls and CAPAs as required. Additionally, they will participate in both internal and external audits and support other Quality operations as needed. The opportunity: Sample Login Preparation and Verification Review sample paperwork to ensure appropriate testing is requested. Verify assignment of Sample Identification Number to each sample for testing. Confirm accuracy of bottle label and customer-provided paperwork. Analytical Data Review and Release Perform data review on all types of analytical testing performed in the lab, including but not limited to, Identification testing, Wet Bench testing, Titration, HPLC, and GC Generate Certificates of Analysis for completed routine QC testing Stability Assist in monthly pull and log-in of stability samples. Ensure required testing documents are available to analysts. Quality Operation Assist with internal facility and system audits on a regular basis Participate in external audits involving customers and regulatory agencies. Assist the sample retention program to ensure adequate capacity and routine disposal of all completed samples. Support the lab and other quality operations as needed.

Requirements

Bachelor of Science in Chemistry or a science-related field
Minimum of three (3) years of experience in a pharmaceutical environment/cGMP laboratory
Experience with reviewing all forms of Analytical Chemistry Data
Working knowledge of cGMP/GLP, USP/NF, ICH and FDA regulations
Knowledge of working with a Laboratory management system (LIMS)
Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel) required
Excellent communication skills; fluent English (oral & written) required.
Able to work independently and with minimal supervision.
Strong organizational skills, ability to prioritize multiple projects, detail oriented.

Responsibilities

Sample Login Preparation and Verification Review sample paperwork to ensure appropriate testing is requested.
Verify assignment of Sample Identification Number to each sample for testing.
Confirm accuracy of bottle label and customer-provided paperwork.
Analytical Data Review and Release Perform data review on all types of analytical testing performed in the lab, including but not limited to, Identification testing, Wet Bench testing, Titration, HPLC, and GC Generate Certificates of Analysis for completed routine QC testing
Stability Assist in monthly pull and log-in of stability samples.
Ensure required testing documents are available to analysts.
Quality Operation Assist with internal facility and system audits on a regular basis Participate in external audits involving customers and regulatory agencies.
Assist the sample retention program to ensure adequate capacity and routine disposal of all completed samples.
Support the lab and other quality operations as needed.