QC Specialist II
Medisca•Irving, TX
•Onsite
About The Position
The QC Specialist II coordinates and executes CED Analytical Labs’ Stability program and supports routine quality control operations. Responsibilities span the stability process, from placing samples and maintaining records to arranging laboratory testing, reviewing data, and preparing Certificates of Analysis (CoAs) and trend reports for customers. The role also supports investigations and quality-system activities, participates in internal and external audits, and assists with other quality projects as needed. The position is located in Irving, Texas.
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 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.
- Fluent English communication skills, both oral and written.
- Ability to work independently with minimal supervision.
- Strong organizational skills and ability to prioritize multiple projects.
- Detail-oriented.
Responsibilities
- Maintain documentation for stability samples, 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 stability samples.
- Generate CoAs and trend reports for completed stability testing.
- Initiate and complete deviations, CAPAs, investigations, out-of-specification (OOS) events, 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.
- Assist with regular internal facility and system audits.
- Participate in external audits involving customers and regulatory agencies.
- Support the laboratory and other quality operations as needed.
- Support other Quality projects.
Benefits
- 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
