Quality Compliance Technician 2nd Shift 2:30pm-11:00pm
Associate Director, QA
The QA technician ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.
- Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
- Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
- Archive and maintain hardcopy and electronic copies of batch records files, audit files, vendor files, product, label files and change history files.
- Provide guidance and training to employees on document control systems and document management procedures.
- Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
- Collaborate with team members and site customers to ensure timely deliverables for documentation.
- Any other activity as assigned by the Supervisor.
Qualifications and Experience
- At least three to three (3) years of experience in a quality assurance role in a cGMP-regulated environment. A college Degree preferably in sciences (i.e., Biology, Chemistry etc.)t three to three (3) years of experience in a quality assurance role in a cGMP-regulated environment.