QC Specialist II
Medisca•Irving, TX
•Onsite
About The Position
The QC Specialist II coordinates and executes the CED Stability program and manages the stability process from sample placement through testing, data review, and customer reporting. The role maintains stability documentation and records, coordinates testing with the laboratory and Stability Lead Chemist, reviews analytical data, and prepares Certificates of Analysis (CoAs) and trend reports in a timely manner. It also supports quality operations, audits, and other quality projects.
Requirements
- Bachelor of Science in Chemistry or a science-related field.
- At least three years of experience in a pharmaceutical environment or cGMP laboratory.
- Two to five years of experience in Quality Control.
- Experience reviewing all forms of analytical chemistry data.
- Working knowledge of cGMP/GLP, USP/NF, ICH, and FDA regulations.
- Knowledge of working with a Laboratory Information Management System (LIMS).
- Knowledge of Microsoft Office, including Word, Outlook, Teams, and Excel.
- Excellent communication skills and fluency in spoken and written English.
- Ability to work independently with minimal supervision.
- Strong organizational skills, ability to prioritize multiple projects, and attention to detail.
Responsibilities
- Maintain stability-sample documentation, including testing records, protocols, and trend reports.
- Place new samples on stability and pull samples for laboratory testing.
- Coordinate with the Stability Lead Chemist to ensure timely testing of samples.
- Generate CoAs and trend reports for completed stability testing.
- Initiate and complete deviations, CAPAs, investigations, out-of-specification (OOS) records, and change controls related to the stability program under management direction.
- Review data from analytical testing performed in the laboratory, including identification testing, wet bench testing, titration, HPLC, GC, and ICP-MS.
- Generate CoAs for completed routine QC and stability testing.
- Generate trend reports for stability studies.
- Assist with regular internal facility and system audits.
- Participate in external audits involving customers and regulatory agencies.
- Support laboratory and other quality operations as needed.
- Support other quality projects.
Benefits
- Paid time off (PTO), vacation policy, and paid statutory holidays.
- Group benefit plan and health savings account.
- Opportunities to learn and grow within CED.
- 401(k) retirement plan.
- Employee referral program.
- Company events throughout the year.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
