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Document Assurance Technician

Kindeva Drug Delivery Company

Los Angeles (CA)

On-site

USD 45,000 - 75,000

Full time

30+ days ago

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Job summary

An established industry player is seeking a meticulous Quality Assurance Analyst to enhance their document management processes. In this pivotal role, you will be responsible for organizing and coordinating critical manufacturing and quality control documents, ensuring accuracy and compliance with regulatory standards. The ideal candidate will thrive in a fast-paced environment, demonstrating exceptional attention to detail and strong organizational skills. This role emphasizes collaboration with various stakeholders to improve documentation workflows. Join a dynamic team dedicated to excellence in pharmaceutical manufacturing and make a significant impact on quality assurance practices.

Qualifications

  • 2+ years of experience in document control or quality assurance roles.
  • Strong attention to detail and organizational skills are essential.

Responsibilities

  • Organize and manage manufacturing and quality control documents.
  • Conduct quality assurance checks and ensure compliance with regulations.

Skills

Detail-oriented
Organizational skills
Communication skills
Time management
Problem-solving

Education

High school diploma or GED

Tools

Microsoft Office Suite
Document management systems

Job description

19901 Nordhoff St, Northridge, CA 91324, USA

Job Description

Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturing (CDMO) business. This position is for a Quality Assurance Analyst for our Northridge operations. Our Northridge site manufactures and packages pharmaceutical products.

Summary of Position

The Document Administrator is responsible for organizing and coordinating manufacturing and quality control documents to ensure organizational effectiveness and efficiency. This includes document filing, storing, retrieving and issuing paperwork. The ideal candidate will have a keen eye for detail, strong organizational skills, and the ability to work collaboratively with internal stakeholders to resolve discrepancies and improve documentation processes.

This position is 100% on site and does not offer hybrid or remote opportunities.

Role Responsibilities:

  • Sorts paper records and files them according to content.
  • Make copies of paper records and distributes as needed.
  • Scans paper records and stores in secure digital locations.
  • Keeps a log of paper records that are taken out.
  • Provides support to internal/external audits as needed.
  • Reviews documents, as needed, for completeness and accuracy.
  • Conduct quality assurance checks on manufacturing documents to ensure accuracy, completeness, and adherence to company policies and regulatory requirements.
  • Compliance Monitoring: Verify that all documentation aligns with company procedures and regulatory requirements.
  • Error Identification & Resolution: Identify inconsistencies, missing information or errors in reports and work with document owners to correct them.
  • Process Improvement: Provide feedback and recommendations to improve documentation processes and templates.
  • Document Management: Maintain organized records of reviewed documents and ensure proper version control, archiving, and retrieval.
  • Collaboration & Communication: Work closely with Supply Chain and Production personnel, to ensure documentation is submitted accurately and on time.
  • Interacts with cross-functional departments to provide guidance on documents, file naming, training and eQMS.
  • Ensuring compliance with regulatory requirements and company policies regarding document management.
  • Coordinate timely completion of document requests.
  • Perform other duties as required.

Requirements:

  • The ideal candidate will have a minimum of 2+ years of experience in document control, quality assurance, or compliance-related roles, preferably in a field operations or industrial setting. In addition, you will have / be:
  • High school diploma or GED.
  • Experience in fast-paced operational environments is a plus.
  • Strong attention to detail and ability to identify errors or inconsistencies.
  • Excellent organizational and time management skills.
  • Strong interpersonal, verbal and written communication skills.
  • Must be able to interface with a variety of people with different technical levels and educational backgrounds; must be detail-oriented and highly organized; and must be able to produce accurate and timely results while maintaining a customer-service attitude.
  • Proficiency in Microsoft Office Suite (Excel, Word, Outlook) and document management systems.
  • Ability to work independently and collaboratively in a high-paced environment.
  • Familiarity with compliance requirements related to field operations, safety, and regulatory documentation is a plus.

Equal Opportunity Employer:

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!

19901 Nordhoff St, Northridge, CA 91324, USA

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