Quality Specialist - Urgent Hire

Job Description:
Exact Schedule - 8am -5pm M-F
fully onsite

Position Summary:
The Quality Specialist will maintain quality assurance programs, procedures and controls, ensuring that finished devices are inspected and/or reviewed to ensure they meet medical device requirements and are of the highest quality standards prior to release for sale. This role will also be responsible to ensure that sophisticated device history records (DHR) are maintained in an organized manner and able to be assembled quickly for audit purposes.
At the West Hills site, we are committed to improving the quality of life of transplant patients and their families by developing and producing innovative, high quality HLA products for the clinical and research segments of the transplant community!

Key Responsibilities:

• Perform product inspections as required to ensure conformance to specifications
• Review label submissions as required and produce labels to ensure conformance to specifications
• Review of production, packaging/labeling and laboratory documents for final product release
• Assemble device history records
• Systematically release finished and semi-finished product based on conformance to established standards
• Scan and/or prepare DHRs for Archive and offsite scanning and ensure legibility and accuracy of electronic storage
• Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems
• Maintain ownership of SOPs and train colleagues on SOPs as needed
• Generate, identify, and suggest quality/process improvements
• Assist writing as well as assist others in writing new or updated operating procedures and/or work instructions
• Assist in document preparation/presentation for regulatory agency visits and
• Corporate/internal audits.
• Provide real-time support to Product Packaging to prevent backorder, non-conforming materials release and adherence to the production schedule.
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, The
• Product Release Specialist (Engineer I, QA) will ensure quality and compliance and safety in all their actions.
• Complete all required trainings in a timely manner. Attend GMP training as appropriate for the role. Adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed.
• In a timely and prompt manner, identifies, reports, and seeks correction for deviations noted in the workplace. Practice all behaviors in a safe and environmentally responsible manner.

Minimum Requirements:

• A minimum of a High School Diploma is required; Bachelor's Degree in Life Sciences is preferred.
• A minimum of 3+ year's related QA or QC experience required, experience in a GMP regulated environment is preferred.
• Previous experience reviewing and releasing batch records is also preferred.
• Excellent analytical, prioritization, multi-tasking and communication is required.
• Strong leadership skills and the ability to work independently without supervision are required.
• This candidate is required to work effectively on cross functional teams.
• The ability to prepare and present written and verbal reports is also preferred