Job Title: Quality Control Technologist III
Job Type: Permanent Full-Time
Location: New Jersey
We are searching for a full-time permanent Quality Control (QC) Technologist with previous experience in Medical Devices and/or the Pharmaceutical industry to join a progressive and innovative team! This successful candidate will act as Team Lead in the QC Lab to assist the Director and Supervisor on daily operations of the Quality Control laboratory and provide guidance to the QC staff. If you're looking for a chance to advance your career, this is the role for you!
WHAT YOU GET TO DO:
Responsibilities include, but are not limited to:
- Performs and schedules stability, method validations, equipment validations, threshold analysis process and other special testing.
- Act as OJT trainer to train new employees and current employees on new test methods
- Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions
- Provides direction and guidance to Quality Control staff on daily tasks.
- Writes/Revises/Approves SOPs, WI, QCS documents.
- Performs and schedules incoming raw material, in-process, final testing and inspection of Bio Array products according to approved Standard Operating Procedures (SOP’s) and other applicable documents within defined time-frames.
- Reports and escalates out-of-specification results and deviations to the department supervisor and/or manager.
- Assists and leads with investigations, root cause analyses, and reports for out-of-specification results and deviations.
- Monitors stability testing time points, ensures samples are pulled and tested at the correct intervals, and performs data analysis to support QA/QC management
- Coordinates and delegates the maintenance of lab supply inventory, and guides the maintaining, final reviewing, approving and compiling Device History Records; maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP’s).
- Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
WHAT YOU HAVE:
- Bachelor’s degree (BS/BA) in Biology, Chemistry or Science
- Minimum of 2-3 years experience in Quality Control
- Previous medical device and/or IVD experience required
- Working knowledge of 21 CFR820, ISO 13485, and IVDR is required
- Must have experience working on Out-Of-Spec (OOS) projects
- 2-3 years of FDA/GMP experience a plus
- Proficient in MS Office and strong problem-solving abilities
** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.
SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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