Job ID : 34699
Location : New York, NY
Company Name : Matal
Job Type : Full-Time, Part-Time, Contract, Training
Industry : Information Technology
Salary : $106200 - $107700 per hour
No. of Positions : I have ongoing need to fill this role
Required Skills : Good Coaching, Verbal Communication, Good Written Communication..
Benefits : Medical Insurance, Dental Insurance, Vision Insurance, 401K, Life Insurance
Job Description :
- 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.
- Meticulous Attention To Detail.
- Good Coaching And Verbal Communication.
- Good Written Communication.
- Empathetic And Emotionally Intelligent.
- Ability To Work As Part Of A Team.