QA Specialist, Document Control

As a QA Specialist in Document Control at Ossium Health, you'll manage and maintain controlled documents, oversee QA reviews, and ensure the QMS is ready for internal and external audits. Your role will also involve digitizing documents, collaborating with cross-functional teams, and suggesting improvements to existing workflows.

To qualify for the QA Specialist in Document Control role at Ossium Health, candidates should possess an Associate’s Degree along with 2+ years of relevant experience in a document control role. Alternatively, 4+ years of experience without a degree is acceptable. Additionally, proficiency in document management software and strong communication skills are essential.

Ossium Health ensures a supportive and engaging work environment for a QA Specialist in Document Control. With a strong commitment to operational excellence and the health of our patients, employees can expect competitive salaries, options for hybrid work, and a comprehensive benefits package that includes 401(k) matching and generous PTO.

The QA Specialist in Document Control plays a vital role in ensuring compliance at Ossium Health by managing the document lifecycle, ensuring proper documentation practices, and maintaining readiness for audits. This helps uphold CGTP, CGMP, AATB, and CLIA standards, crucial for our operations.

Preferred candidates for the QA Specialist role at Ossium Health should have experience working in a startup or high-growth biotech environment, familiarity with eQMS systems like MasterControl, and a working knowledge of relevant FDA and ISO regulatory requirements related to the tissue, cell, or biologics industries.

To effectively manage document control processes in a fast-paced environment, it's important to prioritize tasks, implement a streamlined system for tracking documents, and maintain open communication with team members to ensure everyone is on the same page regarding document status.

In discussing my experience with quality management systems, I would detail my hands-on involvement with managing documents in previous roles, how I complied with regulatory standards, and the specific QMS tools I've utilized to enhance documentation processes.

To ensure compliance during audits, I focus on maintaining thorough documentation practices, regularly reviewing documents for accuracy, and conducting internal audits to identify and rectify any potential compliance issues before they escalate.

When faced with conflicting priorities, I assess the urgency and importance of each task, prioritize accordingly, and communicate clearly with my team to manage expectations and maintain workflow without compromising quality.

I find document management software like MasterControl and collaboration tools such as Microsoft Office and G Suite to be very effective in maintaining organization, ensuring version control, and facilitating collaboration across teams.

I would approach training team members on document control practices by creating structured training sessions, providing hands-on demonstrations, and ensuring that there are clear resources available for ongoing reference to support their understanding and compliance.

One challenge I've faced was encountering inconsistent formatting in documents. I overcame this by developing a standardized template and conducting a one-time cleanup process, communicating the importance of consistent formatting to ensure accuracy moving forward.

I keep up with industry standards in document control by regularly attending webinars, reading industry publications, and participating in professional organizations focused on quality management and compliance to stay informed on best practices.

My process for digitizing physical documents involves evaluating the need for digitization, ensuring you capture all necessary data, using quality scanning equipment, and implementing a secure electronic document management system for organized storage.

I measure the effectiveness of document control processes by tracking metrics like document turnaround time, the number of audit findings related to documentation, and gathering feedback from team members to continuously improve workflows.