Responsibilities

Job Description Summary:

The Scientist, Quality-Document Control supports document control and records management activities within the Quality Team as part of an End-to-End (E2E) Laboratory Modernization Program. This role is responsible for maintaining controlled documents and ensuring laboratory records are managed in accordance with established quality requirements and regulatory expectations.

Job Responsibilities

• Maintain controlled documents including SOPs, work instructions, forms, and quality records.
• Coordinate document revisions, approvals, archival activities, and retention requirements.
• Ensure document control processes comply with quality system requirements.
• Support document retrieval and records management activities.
• Review documentation for accuracy, completeness, and traceability.
• Collaborate with laboratory personnel to support effective documentation practices.
• Support audits and inspection readiness activities.
• Identify opportunities to improve document control processes and systems.
• Maintain training and compliance in health, safety, environmental, and operational requirements.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:

• Strong technical writing and documentation review capabilities.
• Knowledge of document control principles and records management requirements.
• Excellent organizational skills and attention to detail.
• Familiarity with electronic document management systems.
• Understanding of ISO 17025 and regulated laboratory environments.

Basic Qualifications:

• Bachelor’s degree in chemistry, biology, or related scientific discipline.
• OR Associate degree with 2+ years of relevant quality or laboratory experience.
• Relevant quality-related laboratory experience commensurate with level (entry-level candidates through experienced scientists will be considered).
• Demonstrated ability to work both independently and collaboratively in a regulated laboratory environment.
• Adaptable, self-motivated, and capable of managing tasks with strong attention to detail.

Preferred Qualifications:

• Experience supporting document control systems and quality records management.
• Familiarity with electronic document management systems and LIMS.
• Experience supporting regulated laboratory environments.
• Experience with ISO 17025, GLP, GMP, or FDA quality systems.

Working Environment:

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time.
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite. Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.