Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house Product Development and R&D team create the best-tasting and most cutting-edge formulations of supplements. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of supplement categories. Lief collaborates with entrepreneurial firms to help them build premier brands. Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth. Lief Labs is located in the Santa Clarita Valley (Valencia, CA.) All roles are on-site Monday – Friday.

SUMMARY

As a Quality Assurance Document Control Specialist, you will play a critical role in ensuring the accuracy, completeness, and compliance of all quality-related documentation. You will collaborate with cross-functional teams to maintain a robust document control system, supporting the company’s commitment to producing high-quality products.

EDUCATION:

High School Diploma or GED Equivalent; Bachelor’s degree in a relevant scientific discipline or equivalent experience in the pharmaceutical or biotechnology industry is preferred.

KNOWLEDGE

• Minimum of 3 years of industry experience required.
• Strong understanding of document control principles, quality assurance practices, and regulatory requirements (e.g., FDA, GMP).
• Prior experience in document control, quality assurance, or regulatory affairs within a pharmaceutical or similar regulated industry

SKILLS/ ABILITIES

• Excellent attention to detail and strong organizational skills.
• Proficiency with document management systems and software.
• Effective communication skills, both written and verbal.
• Ability to collaborate with cross-functional teams and manage multiple tasks simultaneously.
• Strong problem-solving skills and a proactive attitude toward process improvement.
• Familiarity with electronic document management systems (EDMS) is a plus.
• Planning & organizing
• Team player attitude that is a highly disciplined, problem-solver with a strong work ethic.
• Flexibility/ adaptability/ multi-tasking

RESPONSIBILITIES

• Manage the document control process, including creating, revising, reviewing, approving, and archiving quality-related documents such as Standard Operating Procedures (SOPs), batch records, protocols, and reports.
• Ensure that all quality-related documents are consistent, accurate, and compliant with regulatory requirements and internal standards.
• Monitor and track document change requests, ensuring proper routing, approval, and implementation according to established procedures.
• Collaborate with subject matter experts, quality teams, and regulatory affairs to ensure that documents accurately reflect current processes and requirements.
• Perform regular audits of the document control system to identify gaps, inconsistencies, or areas for improvement.
• Train employees on document control procedures and processes to ensure understanding and adherence.
• Assist in the preparation of documentation for internal and external audits, as well as regulatory inspections.
• Maintain a secure and organized document repository, both electronically and in hard copy format, ensuring efficient retrieval and storage of documents.
• Stay updated on industry trends, regulations, and guidelines related to document control and quality assurance.
• Additional duties as assigned.