QC Specialist II

1 month ago

Irving, United States Medisca Full time
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 II will be responsible for the coordination and overall management of the CED Stability program. This position is responsible for all aspects of the stability process, including placing new samples on stability, recording information in the LIMS database, pulling samples, working with the lab to schedule testing, reviewing laboratory data and generating Certificates of Analysis to send to the customer in a timely manner. The ability to conduct investigations, deviations, change controls and CAPA's is required. The successful candidate will also participate in both internal and external audits, review routine QC testing data, and support other QC operations as needed.

Your key responsibilities

Stability

  • Review all Stability documentation provided by customer prior to the initiation of a new study.
  • Maintain documentation for stability samples including testing records, protocols, excursion logs and trend reports.
  • Responsible for placing new samples on stability, pulling samples to be submitted to the lab for testing, working with the Stability Lead Chemist to ensure timely testing of samples, and generating CoA's/trend reports for completed testing.
  • Monitor alarms and notify management of excursions.
  • Initiate and complete deviations, CAPA's, Investigations, OOS' and change controls related to the stability program under the direction of management.

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.
  • Generate Trend Reports for Stability studies.

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.

Support other Quality Projects

Skills, knowledge and abilities

  • Bachelor of Science in Chemistry or a Science related field.
  • Minimum of three (3) years of experience in a pharmaceutical environment/cGMP laboratory.
  • Two (2) - five (5) years in Quality Control.
  • 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 ...

  • Balance Your Life - 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 CED
  • Save for your Future - 401k plan retirement
  • Help us grow - Employee Referral Program
  • We like to have fun - company events throughout the year

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

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

#LI-Onsite

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