The Quality Assurance Document Control & Training Associate plays a central role in maintaining compliance and operational efficiency across both GxP and research and development environments. This position manages documentation workflows and training records within an Electronic Document Management System, ensuring accuracy, traceability, and adherence to established standards in a fast-paced, science-driven setting.
Key Responsibilities
- Manage document lifecycle activities in the EDMS, including issuance, formatting, version control, and archival
- Assign and verify unique identifiers such as lot numbers and labels for controlled materials
- Format and revise controlled documents using approved templates and procedures
- Digitize, scan, and track physical records, including coordination of off-site storage requests
- Support inspection readiness by retrieving documents, fulfilling auditor requests, and generating official copies
- Maintain employee training records and ensure job-specific documentation is current
- Assist with onboarding new personnel and contribute to continuous improvement of orientation processes
- Support training operations through report generation, verifications, approvals, and system updates
- Monitor document expiration and review cycles to ensure timely updates
- Provide guidance and training to staff on EDMS usage as needed
- Collaborate on the development and revision of document control procedures aligned with quality standards
- Perform additional duties in support of quality and compliance objectives as required
Qualifications
Applicants must hold a bachelor’s degree and have prior experience in a GxP-regulated environment. Demonstrated ability in document review, procedural writing, and record management is essential. Proficiency in Microsoft Word, Excel, Outlook, and Adobe Acrobat is required. Strong attention to detail, organizational capability, and communication skills are critical. Candidates should be self-motivated, capable of managing time effectively, and willing to work overtime when necessary. A criminal background check is required for employment.
Preferred candidates will have 1–2 years of experience in document control or a related function and hands-on experience with Veeva or similar systems.
Work Environment
This is an onsite role with locations in Fishers, Indiana or Lexington, Massachusetts. The schedule may shift based on business demands, requiring flexibility and responsiveness. The work supports a culture grounded in scientific rigor, operational resilience, and a commitment to patient impact.
Compensation & Benefits
- Competitive compensation package including Share Appreciation Rights
- Immediate vesting 401(k) match up to 6% of salary
- Multiple healthcare plan options with FSA and HSA availability
- Dental and vision coverage
- Employer-paid basic life and personal accident insurance
- Voluntary disability, universal life, and AD&D coverage options
- Generous time-off policy: paid vacation (based on tenure), sick time, 10 observed holidays, 2 floating holidays, and 1 volunteer day
Equal Opportunity Employer
This organization participates in E-Verify and is committed to equal employment opportunity. All qualified applicants will be considered without regard to race, color, religion, national origin, sex, age, citizenship, disability, or any other protected status.
