What are the responsibilities and job description for the Quality Assurance Specialist position at Caligor Coghlan?
Company Description :
Caligor Coghlan (CalCog) is a vertically integrated clinical supply services company that provides sourcing, packaging, labeling, storage, and distribution services for early to late phase global clinical trials. We pride ourselves in making it our business to find a better way to deliver for our clients and the patients they serve. Our dedicated people care - about their work, their team, and the results we strive to deliver every day.
If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.
Job Summary :
The Quality Assurance (QA) Specialist, Level III, will be responsible for the daily execution of tasks associated with internal / external audit and non-conformance administration (Incident / Deviation / Complaint / CAPA). Additionally, this position will be responsible in assisting of receiving / inspection / release of labels, receiving / inspection / release of clinical trial materials and its ancillary supplies, review of batch records, review of distribution material review of maintenance logs, and other functions and / or cross-functional tasks essential to the daily operations of the Quality Assurance department.
Key Responsibilities :
- Working with the QA Director to maintain and improve the daily QA operations.
- Ensures compliance to GxP and SOPs for assigned tasks and responsibilities.
- Identifies operational quality problems, issues, obstacles, and barriers across production and shipping related activities and communicates observations, patterns and trends to QA Director, as appropriate; participates in and supports efforts to develop and implement quality process improvements.
- Provides and / or organizes Quality system training for new and existing personnel to improve compliance. Supports the development and presentation of quality systems training material.
- Leads and assists in the preparation, coordination, and execution of internal / external audits.
- Maintains and monitors quality metrics. Compiles Monthly / Quarterly / Annual quality metrics reports. Assists in the preparation of Quality metrics for Management Review meetings.
- Assists in the communication with prospective vendors, qualification of new vendors, and re-qualification of previously qualified vendors.
- Provides assistance in reviewing / releasing Receiving records, Distribution records, Pre-production / Post-production Batch Records (as needed).
- Provides assistance in reviewing / releasing of labels for production, including review of label text per client approved label proof and randomization files.
- Provides in-process QA inspections for all outbound shipments (as needed).
- Assists management with planning and facilitating Regulatory or client audits.
- Assists with the organizing, planning, and drafting of audit responses.
- Works directly with clients and project management as needed to provide Quality solutions and feedback.
- Leads Quality projects as assigned by QA Director.
- Provides mentorship to junior level Quality team members.
- Other duties or tasks as assigned by QA Director.
Competencies, Traits and Skills :
Qualifications :