The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the 74/76 NYA Manufacturing Facility. The department performs analytical testing on intermediate, in-process and final product materials using a variety of equipment to include GC, FTIR, UV VIS, and physical property instrumentation.
Position Summary
Supports Biosurgery Business by performing in-process, stability, and release testing for
Biosurgery Product lines.
Core Responsibilities
Perform Assays in accordance with SOPs for release, stability, and in-process samples.
Review peer data including data transcription, data calculation, and log entries.
Lab general duties include cleaning, glassware, washing, etc.
Initiate DCR when assigned.
Train on all documents assigned to a training plan and complete training as assigned.
Receive, verify and log incoming samples.
Perform or participate in Equipment Qualifications.
Perform or participate in Method Validations.
Participate in audits.
Complete training as assigned.
Author technical reports.
Bring in new equipment (spec, URS, etc.)
Perform PM or calibration on lab equipment.
Conduct safety and weekly compliance walkthroughs.
Responsible for adherence to policies, procedures, and SOPs.
Participate in Lab Investigations.
Perform OOS investigations as an Analyst.
Adhere to Site Quality and Safety Policies.
Work toward the accomplishment of Site Goals.
Initiate and help investigate deviations through Trackwise.
QC testing of in-process, stability, and release samples in a GMP lab.
Troubleshooting of assay/equipment issues.
Coordinator Roles that may be assigned:
Metrology
Purchasing
Documentation
CSO
Safety
Assay occasion tracking
Logs
Reserves
Product Point of Contact
Data Back-Up
BASIC QUALIFICATIONS
Bachelor's degree in Life Sciences or equivalent (Chem, Bio, Microbio, etc)
3-6 years of lab experience.
PREFERRED QUALIFICATIONS
Experience in laboratory techniques such as pH, GC, UV/VIS, and FTIR.
Experience in GMP laboratory as well as technical writing.
Strong attention to detail and ability to multitask.