Quality Analyst

Responsibilities:

• Performs reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinates and tracks CAPA, NCR and Deviation records, ensuring tasks are completed on time.
• Coordinates and tracks the site environmental monitoring (EM) testing program.
• Assists teams in coordination of problem solving and root cause analysis for associated quality events.
• Ensures the development, review, and release of quarterly EM trending reports; Assures significant trends are immediately brought to management attention.
• Provides input based on knowledge and experience with batch release requirements.
• Provides QMS Operations related support to all CGMP departments.
• Performs Quality Control activities at AxoGen's processing or distribution sites. The Quality Analyst will be
• responsible for incoming material inspections, in-process inspections and finished product inspections.
• Products include Medical Devices, sterile processed Human Tissue-Based Products, unprocessed human tissue, components supplies and labeling materials.
• The Quality Analyst will maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Provides support related to gowning qualification and training.
• Ensures timely issuance, review, and approval of Microbiology and EM testing results.
• Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
• Assists in the review and approval of equipment qualifications.
• Assists in the review of Calibration and Preventative Maintenance reviews.
• Assists in hosing of onsite regulatory audits and inspections.
• Knowledge of current Good Manufacturing Practices  and relevant regulatory standards, guidelines and regulations, both in the US and OUS for tissue, Medical Devices and/or Biologics
• Knowledge of statistical sampling and analysis.
• Knowledge of Root Cause Analysis  methodologies.
• Knowledge of current global initiatives, including Quality by Design, Process Validation, and Data Integrity.
• Knowledge of biologics or pharmaceutical batch review & release.
• Skill in oral and written communication.
• Skill in organizational techniques and practices.
• Skill in interpersonal and team building techniques.
• Ability to proficiently use MS Office Suite, including Microsoft Visio and Project.
• Ability to exercise creativity and demonstrate good judgment.
• Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.

Key Skills:

• Meticulous Attention To Detail. 
• Analytical. 
• Good Coaching And Verbal Communication. 
• Good Written Communication. 
• Empathetic And Emotionally Intelligent. 
• Ability To Work As Part Of A Team. 
• Goal-Oriented.