Job Description
Job Description
Description:
- Title: QC Stability Study Coordinator I
Summary
- With limited supervision, QC Stability Study Coordinator, is responsible for the oversight of stability program management in accordance with cGMP regulations.
- These duties include execution of trend analysis, documentation review, support of deviations (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Stability Study Coordinator works to meet departmental and organizational goals.
Job Responsibilities
- Review data and assess against established acceptance criteria
- Perform technical review of peer-generated data
- Evaluate data to identify trends and/or establish limits
- Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
- Identify and troubleshoot technical problems
- Identify gaps in systems and procedures
- Receive training
- Support the maintenance and compliance of operational areas
- Assure and apply GMP throughout operations
- Coordinate with customers to support multi-site operational activities
- Support internal and external audits and regulatory inspections
- Works to meet schedules, timelines, deadlines
- Participate in and/or lead group and project teamwork; project and process improvements
- Stability Protocol Creation
Stability deviation assessments - Routine Master Data Testing Creation
- Routine Master Data Testing Review
- Routine and non-routine Out Of Trend linear regression assessments.
- Annual Product Quality Reviews (APQRs) - Author assistance develop to authoring
- Time Point Approval assistance
Change control of various documents - Data / Data Table requests / annual report requests (non-routine requests) (e.g.,
Client monitor requests) - Actively participate in various stability related projects
- Data entry and review
- Assist with training coordination
- Assist with Perform other duties as requested by managers to support Quality activities
Job Requirements
- B.S. /B.A. degree and 1-3 years of experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.
Strong verbal and written communication skills, ability to organize and present information both formally and informally. - Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
- Routinely exercises sound judgment, reasoning and problem solving.
- Capable of working under limited supervision and determining own short term priorities.