Kelly Services
Location
Irving, TX | United States
Job description
Kelly Science & Clinical is actively recruiting for a Quality Control Specialist II for a Direct Hire opportunity in Dallas, TX.
As a Quality Control (QC) Specialist II you will be responsible for the coordination and overall management of the Client 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.
Responsibilities & Duties
Review all Stability documentation provided by customer prior to the initiation of a new studyMaintain 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 excursionsInitiate and complete deviations, CAPA’s, Investigations, OOS’ and change controls related to the stability program under the direction of management.
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
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 * * * * Qualifications
Bachelors of Science in Chemistry or a Science related field
Minimum of three (3) years of experience in a pharmaceutical environment/cGMP laboratoryTwo (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. This is a direct opportunity with a Monday through Friday, 8:00am-5:00pm work schedule. Salary is commensurate upon level of education and applicable experience.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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