Document Coordinator I

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. 

The Impact You Will Make

In this role, you will be responsible for managing and maintaining controlled GMP documents, ensuring compliance with regulatory and company standards. You will collaborate with cross-functional teams, format and finalize documents, and manage document databases. Success in this role requires strong attention to detail, advanced Microsoft Word skills, and effective communication.

Responsibilities

· Create, audit, and maintain GMP documents, including SOPs, Master Batch Records, Design History File Documents, Test Reports, and Material Specifications.

· Create electronic logbooks and electronic batch records.

· Collaborate across cross-functional teams to track and manage document revisions, approvals, and distribution.

· Oversee controlled document and logbook creation, issuance, reconciliation, and archival.

· Develop, maintain, and distribute KPIs to indicate health of document management system.

· Support internal and external Audits.

Qualifications

· Bachelor’s degree or Associate degree in technical or science discipline or equivalent combination of education and experience.

· Experience in the pharmaceutical/combination product/medical devices/Quality Assurance environment.

· Strong proficiency in Microsoft Word and Excel.

Preferred Skills & Competencies:

· Detail-oriented with excellent organizational and time management skills.

· Ability to follow procedures, manage multiple tasks, and prioritize effectively.

· Strong analytical and problem-solving skills.

· Effective verbal and written communication abilities, and ability to collaborate with cross-functional teams and maintain confidentiality.

· Adaptability to changing priorities and regulatory requirements.

Additional Skills:

· Strong interpersonal skills with a customer-service mindset.

· Commitment to quality, safety, and compliance standards.

#LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!