This role focuses on supporting documentation activities for diagnostic product lines. The position does not involve laboratory work and is fully onsite. The individual will update and manage documentation related to diagnostic products, ensuring compliance with specific operating procedures and timelines.

Key Responsibilities
Review plans outlining required changes to documentation and execute these updates across various document types and systems.
Ensure compliance with operating procedures and regulatory standards for each document type.
Collaborate with cross-functional teams and management for project alignment and task support.
Work independently on assigned products to manage activities and timelines effectively.
Use systems and software to process document changes, troubleshoot formatting issues, and meet project deadlines.

Qualifications

Education:
Bachelor of Science in molecular biology, biochemistry, or related field preferred.
Open to candidates with other bachelor’s degrees and relevant experience.

Experience:
2-4 years of experience in a related field preferred.
Familiarity with GMP, ISO, FDA regulations, and audits is a plus.
Knowledge of process and test method validations is advantageous.

Skills:
Formalized document change control experience.
Strong computer aptitude with proficiency in Microsoft Word, Adobe Acrobat, and other documentation tools.
Project management skills, including the ability to track and manage multiple product activities.
Critical thinking and problem-solving skills.
Excellent communication skills with the ability to work independently and professionally address challenges.

Top Skills for Success:
Industry experience with documentation updates.
Strong work ethic and ability to meet deadlines.
Effective communication with minimal oversight.
Ability to analyze and follow detailed operating procedures.