Quality Assurance (QA) Compliance Specialist II

Job Description

Company Description

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities:

Coordinate and execute electronic document change-control activities in compliance with internal procedures.

Work directly with the DST Team Lead for training and task guidance, taking on increased responsibility over time.

Ensure accuracy in document processing tasks including assessment, execution, verification, and administration.

Communicate proactively with team members and leadership, escalating issues or questions as needed.

Utilize tools such as Microsoft Excel (pivot tables, data exports), Outlook, TEAMS, SharePoint, and electronic DMS platforms.

Support collaborative efforts across scientific and compliance teams in a fast-paced environment.

Requirements:

Associate’s degree required; high school diploma with relevant certifications may be considered.

Bachelor's degree in a scientific or technical field.

Prior experience with scientific document management in an electronic document management system (EDMS).

Business communication skills and proficiency with Microsoft Office, especially Excel.

Document Management Systems (e.g., Viva Vault/One Vault).

Microsoft 365 tools (Excel, Outlook, TEAMS, SharePoint).

Familiarity with scientific terminology (e.g., chemistry, biology, analytical testing, clinical studies).

Excellent keyboarding and attention to detail in document/data entry and change-control management.

Proficient in standard office applications, particularly Excel data tools and pivot tables.

Proactive and clear communicator; able to work independently and escalate when needed.

Strong organizational and self-checking skills; dependable and accountable without requiring extensive direction.

Focused on precision and consistency in process and procedural documentation.Additional Information

All your information will be kept confidential according to EEO guidelines.

Full-time