Quality Assurance 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

The Quality Assurance Specialist is responsible for ensuring that all products meet the highest quality standards and comply with regulatory requirements. This role involves meticulous attention to detail, excellent analytical skills, and a strong commitment to maintaining product safety and efficacy and manufacturing support, document control and training systems to assure cGMP compliance for all relevant operations carried out within. Assists the Quality Manager with internal and external audits. Prepares and keeps auditing protocol. Verifies that new products meet quality standards. Performs root cause analysis and works to ensure a non-conforming product is addressed.

Responsibilities

• Quality Control: Perform routine inspections and tests on raw materials, in-process products, and finished goods to ensure compliance with quality standards. Ordering supplies for Quality Assurance and Regulatory Affairs. Creating, filing, and monitoring controlled logbooks in Operation
• Documentation: Maintain accurate records of inspections, tests, and corrective actions. Prepare detailed reports on quality assurance activities and findings. Generating Certificate of Analysis (COAs). Reviewing and approving Master Manufacturing Records (MMRs). Reviewing, scanning, and filing Batch Production Records (BPRs). Assist/support complaint investigation and data gathering. Maintain/Update KPIs, deviation tracking log, task tracker etc.
• Write and review Standard Operating Procedures, Work instructions, Process flows, Quality Standards, etc. (where required).
• Regulatory Compliance: Ensure that all products comply with FDA regulations, GMP (Good Manufacturing Practices), and other applicable standards. Approve/release finished products.
• Process Improvement: Identify areas for improvement in the production process and collaborate with the production team to implement effective solutions.
• Training: Conduct training sessions for staff on quality assurance procedures and regulatory compliance requirements.
• Audits: Participate in internal and external audits, ensuring that all quality systems are in place and functioning correctly. Support internal audits of departments involved in GMP activities. Supports client and regulatory audits as needed
• Problem-Solving: Investigate product quality issues and customer complaints, determine root causes, and implement corrective actions to prevent recurrence.
• Cross-Functional Collaboration: Work closely with R&D, production, and supply chain teams to ensure quality is maintained throughout the product lifecycle.
• Additional Duties as assigned.
  
  

Supervisory Responsibilities

None

Minimum Qualifications

Education

• Bachelor’s degree in Chemistry, Biology, Food Science, or a related field, preferred
  
  

Experience

• Minimum 1-2 years’ quality assurance within the pharmaceutical or nutraceutical industry with experience in a GMP regulated environment.
• Proficient in MS Word, Excel, and Power Point
• Understanding of FDA regulations, GMP, and quality control procedures
  
  

Skills/ Abilities Problem Solving

• Strong analytical and problem-solving abilities.
• Excellent attention to detail and organizational skills.
• Proficiency in quality control software and tools.
• Effective communication skills, both written and verbal.
• Ability to work independently and as part of a team. Verbal Communication
• Written Communication
• Relationship Management
• Quality Orientation
• Ability to interact at all levels
• Ability to work as a team member
• Flexibility/ adaptability/ multi-tasking
• Bilingual communication skills a plus
  
  

Work Environment

The office is clean, orderly, properly lighted, and ventilated. Noise levels are considered low to moderate. Field conditions vary.

Exposed to various raw materials, including allergens (i.e. milk, eggs, fish, shellfish, tree nut, peanuts, wheat, soy).

Physical Demands

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

The employee must frequently grasp, lift and/or move and carry items up to 10-50 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 $25-32/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 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.