Job Summary
We are seeking a highly detail-oriented and organized individual to join our team as a Quality Assurance Specialist. The ideal candidate will have experience in the pharmaceutical industry, quality control/quality assurance, or a related scientific field.
Key Responsibilities
* Review executed batch records and create certificates of packaging.
* Support QA Pre-Approval by reviewing and approving pre-executed batch documentation, finished products, and change orders.
* Liaise with project managers to ensure documents meet customer and regulatory requirements.
* Coordinate internal communication regarding documentation reviews and approvals.
* Supply information internally to support project planning.
* Provide support to improve documentation right first time metrics.
* Document deviations or quality issues.
* Analyze data for quality metrics.
* Inform supervisors of quality issues.
* Maintain accurate records for all work activities.
* Train new team members and other FCS departments.
* Organize and document GMP archival.
* Support the larger Quality department on tasks such as Practical Process Improvement projects.
* Review and disposition transport deviations and temperature excursions.
* Support Pharma Unit Trackwise problem reports.
* Act as a customer quality contact answering client questions.
Requirements
* Bachelor's degree in science or equivalent.
* GxP training or experience.
* Demonstrated ability to perform detail-oriented tasks.
* Excellent communication and organizational skills.
* High level of accuracy and efficiency.
* Ability to express detail in simple terminology.
* Proficiency in English and German at professional level.