QC Specialist II
Medisca
Summary
The QC Specialist II will be responsible for the coordination and execution 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 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.
Job description
Responsibilities & Duties
Stability
- Maintain documentation for stability samples, including testing records, protocols, 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 CoAs/trend reports for completed testing.
- Initiate and complete deviations, CAPAs, Investigations, out-of-specification (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
Requirements
- 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
Benefits
- Paid time off
- Vacation policy
- Paid statutory holidays
- Group benefit plan
- Health savings account
- 401(k) retirement plan
- Employee referral program
- Company events
Company overview
Medisca is a global leader in personalized medicine and pharmaceutical compounding solutions, founded in 1989 in Montreal, Quebec. With over 35 years of experience, the company has grown from a small team of three to an international corporation with operations across North America, Europe, and Australia, serving tens of thousands of healthcare clients worldwide. Medisca specializes in providing comprehensive pharmaceutical compounding solutions, including high-quality ingredients, precision equipment, proprietary technologies, analytical testing services, IP licensing, and accredited education programs. The company maintains a vast portfolio of over 2,000 product solutions complemented by a library of 10,000+ proprietary and customized medication formulas. Operating under cGMP-compliant practices with just-in-time logistics, Medisca ensures consistency, quality, and compliance throughout the pharmaceutical supply chain. As "Partners in Wellness," the company empowers healthcare providers to deliver safe, customized therapies that improve patient outcomes, bridging gaps in healthcare through innovative pharmaceutical solutions and strong international partnerships.