Quality Assurance Document Control Specialist (On-site)

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.

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.
  
  

Supervisory Responsibilities

None

Education

Minimum Qualifications

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
  
  

Physical Demands

While performing the duties of this job, the employee may regularly require talking, hear and grasp items. This position is active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day.

Regularly exposed to moving mechanical parts, strong fumes, loud noises, and occasionally extreme temperatures.

The employee must frequently grasp, lift and/or move items 20 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Additional Information

The Salary Range for this position at Lief Labs is $22.00 - $30.00 hour (USD). Starting pay for the successful applicant depends on a variety of job-related factors, including but not limited to market demands, experience, training, skills, and education. The benefits available for this position include medical, dental, vision, 401(k) plan, life insurance coverage, wellness benefits, education reimbursement program, and PTO. This position is bonus eligible.

Lief is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request accommodation, contact the Lief Human Resources department.

Lief will consider employment-qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.

Lief uses E-Verify to confirm work eligibility in the United States. E-Verify compares the information on your Form I-9, Employment Eligibility Verification, to official government records.