QA Specialist/ Senior QA Specialist

Mar 11, 2024

Join the revolution in cancer early detection at Mercy Bio! We’re a pre-commercial biotechnology company on a mission to transform the future of healthcare by uncovering cancer’s hidden biology. With a commitment to accessibility and equity, we’re dedicated to making high performing blood-based cancer screening solutions that are available to all who need them. Be part of a fast-paced team with a focus on collaboration on our quest to conquer cancer care – join us in making a meaningful difference!

We are looking for an experienced and motivated candidate to join our Quality Assurance (QA) team. This individual will be tasked with supporting the quality department in the maintenance, management, and development of Mercy BioAnalytics Quality Management System.  In addition, the QA Specialist will interact with cross-functional teams to promote quality culture.

 

Responsibilities:

  • Conduct thorough QA review and approval of Standard Operating Procedures (SOPs) and associated documents in accordance with 21 CFR 820 regulatory standards and ISO 13485, collaborating with cross-functional teams to author, review, revise, and maintain SOPs
  • Champion the implementation and continuous maintenance of Design Control processes, meticulously ensuring compliance and an unwavering adherence to high quality standards across all stages of the product development lifecycle
  • Play a pivotal role in developing, refining, and sustaining the Quality Management System (QMS) to uphold regulatory compliance and elevate quality standards
  • Serve as a Quality representative in cross-functional teams to ensure quality objectives are met across departments, including the monitoring of key quality metrics to track performance and drive continuous improvement initiatives
  • Conduct risk assessments related to product design and development. Work closely with program teams to identify and mitigate risks associated with design changes
  • Facilitate and coordinate training of employees on new procedures related to Quality Management System, fostering a culture of continuous improvement and compliance
  • Perform investigations and lead the timely completion and documentation of deviations, NCRs, and CAPAs

Requirements:

  • Minimum BS degree, Science or Engineering preferred
  • 2-5 years of experience in a Quality or Manufacturing role in a regulated environment
  • Solid understanding of FDA QSR and ISO 13485
  • Ability to manage multiple priorities and meet deadlines
  • Excellent verbal and written communication skills
  • Demonstrated experience with Design Control processes
  • Proficient in Microsoft Office Suite and eQMS, showcasing adeptness in computer skills essential for modern quality assurance roles

Candidates for this position must enjoy working for a fast-paced, cutting-edge company and demonstrate exemplary team capabilities and a passion for contributing to our life-saving mission.

Hiring Manager: Quality Assurance Manager

Location: Flexible (on-site, hybrid or remote)

Status: Full Time

Job ID: QA002

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