Quality Assurance Records Specialist

2 weeks ago

San Diego, California, United States Werfen Full time

Overview:

Werfen

Werfen is a dynamic, family-owned enterprise established in 1966 in Barcelona, Spain. We are a global frontrunner in specialized diagnostics across various fields including Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplantation. Through our Original Equipment Manufacturing (OEM) division, we engage in the research, development, and production of tailored assays and biomaterials. Our operations span 30 countries and over 100 territories through distribution partnerships. Our Headquarters and Technology Centers are strategically located in the US and Europe, supported by a workforce exceeding 7,000 professionals.

Our achievements stem from a concentrated focus on these swiftly advancing diagnostic sectors, unwavering commitment to our clients, and a steadfast dedication to innovation and quality. We are passionate about equipping healthcare professionals with the most effective and comprehensive solutions to enhance hospital efficiency and improve patient outcomes.

Position Summary:

The Quality Assurance Records Specialist is tasked with the evaluation and auditing of Manufacturing and Quality Control (QC) documentation related to the release of finished products, primarily focusing on Device History Records (DHRs). This role involves overseeing the archives of DHRs, Device Master Records (DMRs), and other quality documentation, ensuring the accuracy, clarity, traceability, and accessibility of these records. Furthermore, the Specialist is responsible for verifying that quality documentation associated with product packaging and distribution is complete and precise.

Key Responsibilities:

  • Conduct thorough reviews of DHRs for designated products; as appropriate, authorize product release via the Enterprise Resource Planning (ERP) system.
  • Consistently strive to meet assigned review timelines; address unanticipated workload fluctuations to guarantee prompt product release.
  • Facilitate the resolution of discrepancies in DHR quality documentation; collaborate with document preparers to clarify questions, inconsistencies, or missing data.
  • Stay informed about all specifications and requirements relevant to quality documentation. Remain updated on current Good Manufacturing Practices (cGMP) and the manufacturing material/product process flow.
  • Provide data and metrics regarding the accuracy, completeness, and cycle times of reviewed records. Identify areas requiring enhancement, particularly concerning the accuracy, completeness, and cycle times of the quality record process.
  • Prioritize urgent matters. Identify issues and implement corrective actions. Offer additional administrative support as needed.
  • Participate in regulatory audits as required.
  • Engage in assigned special projects as directed.
  • Ensure compliance with the company's quality system requirements through training and adherence to established policies, procedures, and processes.
  • Perform other duties as assigned.

Qualifications:

Minimum Knowledge & Experience Required:

  • High school diploma or equivalent experience preferred; a Bachelor's degree in Life Sciences is advantageous.
  • Three (3) to five (5) years of relevant experience in Quality Records/Quality Assurance; experience in a regulated medical device manufacturing or pharmaceutical environment is preferred.
  • Familiarity with cGMP, GDP, FDA, and ISO standards is preferred.
  • Proficient in Microsoft Office applications.
  • Experience with large enterprise resource planning (ERP) systems and accounting software is a plus.
  • Prior experience with regulatory audits is beneficial.
  • Technical writing experience is an advantage.
  • Must be self-driven and capable of working independently; must also thrive in a team environment.
  • Strong communication, organizational, and time management skills; attention to detail is essential.
  • Able to identify and resolve issues effectively.

If you are eager to learn continuously and face new challenges regularly, we encourage you to consider this opportunity.

Werfen is an Equal Opportunity employer committed to fostering a diverse workplace. We strictly prohibit unlawful discrimination, harassment, or retaliation based on any protected characteristic as defined by applicable state or federal law.

Our operations extend across over 30 countries, with annual revenue approximating $2 billion and a global workforce of more than 7,000 individuals comprising the Werfen team.

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