QA Manager - Direct Hire

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is seeking a Quality Assurance Manager to administer and fulfill all the regulatory and standards requirements of the Quality Management System (QMS). This role is responsible for maintaining the QMS, keeping the document review cycle up to date, and addressing/updating the QMS open issues timely.

Primary Responsibilities

• Plan, conduct, and report internal or external quality audits, including the creation and tracking of related corrective actions.

• Update issues in the QMS and assist SMEs and other assignees to complete tasks following procedures and standards, including appropriate root cause analysis.

• Maintain the document review cycle and prioritization matrix ensuring updates by continuously communicating with assignees and senior managers to streamline the review process.

• Create, update, and conduct all the validation protocols for critical equipment and software, and plan in alignment with departmental managers to ensure validations are effectively completed in a timely fashion.

• Assists the QA Director and/or Senior Management with compliance activities, audits, documentation, and communications with external regulatory bodies and standards organizations (FDA, ISO, COLA/CLIA, and other regulatory bodies).

• Assists and ensures that Equipment Validation, Calibration, and Preventative Maintenance are up to date.

• Liaise between the QA Director, Staff, and other Managers to ensure Corrective Action and Preventive Action (CAPA) Investigations are effective and ensure continuous improvements.

• Liaise with Software developer leads, the QA Director, and/or Senior Management to assist with the implementation of 510k BECS systems and other provisions for regulatory compliance.

• Liaise with the QA Director and/or Senior Management to determine, measure, and report on Key Performance Indicators (KPIs) from the Quality Assurance department and/or for the organization in general.

• Performs other job functions defined by Management, as appropriate and required.

Qualifications

• 6 -10 years of experience in Quality Assurance, preferably in a related field to Blood Banking, IVD, or Pharmaceutical/R&D institutions.

• Knowledge of safety requirements and legal standards from FDA, CLIA/COLA, ISO 9001 preferred.

• Experience analyzing and navigating through regulatory requirements contained in the CFRs.

• Knowledge of standards and regulatory framework, especially regarding Biological products.

• A keen eye for detail, excellent communication, and planning skills.

• Working knowledge of Quality Management System requirements and maintenance practices.

• Experience with MS Word, Excel, Project Management, and Analytics software, as well as general Computer proficiency.

• Experience with database management.

• Must be able to read efficiently, write legibly, and speak English fluently. Spanish is a plus.

• Maintain open, effective, and professional communication with supervisors and cross-functional teams.

• Continuously assess needs, requirements, and project activities to allocate time and resources effectively.

• Be willing to learn, research, and develop new skills and knowledge of the organization, its processes, and innovations.

• Desire for growth and innovation, following instructions while also proposing solutions. Flexibility and adaptability are critical.

• Be punctual and work around critical projects and timeframes.

• Collaborate effectively with team members across the organization.

Education & Certification

• Bachelor's degree in Biology, Science, Quality Management, Engineering, Business Administration, or a related field.

Note: This is a Direct Hire position with the Client.

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