QC Specialist I

Full Time
Irving, TX 75063
Posted
Job description

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 conduct investigations, deviations, change controls and CAPA’s as required. Additionally, they will participate in both internal and external audits and support other Quality operations as needed.

Your key responsibilities:

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, GC, ICP-MS, etc.
  • Generate Certificates of Analysis for completed routine QC testing and Stability testing.

Stability

  • Assist in the review of all stability documentation provided by the customer prior to the initiation of a new study.
  • Generate interim reports for all studies.
  • Monitor alarms and notify management of any excursion.

Quality Operation

  • Assist with internal facility and system audits on a regular basis
  • Participate in external audits involving customers and regulatory agencies.
  • Support the lab and other quality operations as needed.

Skills, knowledge and abilities

  • Bachelors 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.

What’s In It For You …

We invest time and resources into making sure Medisca is as good as the people we hire.

  • Work/Life Balance – PTO, vacation policy and paid statutory holidays
  • Invest in your health – Group Benefit plan and health savings account
  • Your Future is Bright – Opportunities to learn and grow within Medisca
  • Save for your Future – Medisca contributes to a 401k plan when you invest in the pla
  • Help us grow – Employee Referral Program
  • We like to have fun – company events throughout the year
  • Full time positions - 40 hour work week
  • Your safety is important – Medisca provides an allocation to purchase safety shoes

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.

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