Quality Assurance Associate

1. Junior-level candidate with 1 years of experience.
2. Strong interest in Quality Assurance and compliance-related work.
3. Document control experience is required and considered a dealbreaker.

1. Prior experience in a regulated environment and Exposure to regulatory and compliance requirements, including:

1. Support QA and document control processes for the project.
2. Ensure documentation is maintained accurately and in compliance with regulatory requirements.
3. Contribute to quality and compliance initiatives supporting business-critical deliverables.

1. Maintain periodic review compliance by communicating and following up with document owners.
2. Maintain quality document lifecycle through scanning, storing, and archiving in accordance with the Client QMS.
3. Responsible for working and interacting cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.
4. Ensure that records are kept under CLIA, CAP, NYS, and CA requirements such as attributable, legible, original, contemporaneous, and accurate.
5. Review all Quality documents for clarity and alignment within operations.
6. Ensure that equipment standards are tested, calibrated, and standardized before patient testing.
7. Assist with Lot-to-Lot validations of new reagents.
8. May assist with nonconformance investigation and root cause analysis.
9. May assist with incoming material review.
10. May assist teams on internal audits.
11. Other duties as assigned.
12. Bachelor's degree or equivalent related experience within a quality assurance, compliance, document control or similar function of a biotechnology, clinical, or diagnostic laboratory;
13. An advanced degree without experience

1. 1 years of QA experience
2. ASCP or AMT clinical laboratory scientist certification
3. Excellent attention to detail and multitasking skills
4. Familiarity with MA & NYS regulations, CAP, and CLIA
5. Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem-solving with departments and colleagues
6. Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow
7. Demonstrated ability to consistently meet or exceed project deadlines
8. Understanding of HIPAA and the importance of privacy of patient data
9. Ability to work well under pressure while maintaining a professional demeanor.

Salary : $37