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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.

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.

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All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. is not a Consulting Company/Training Company/H1B Sponsor.

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