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.)

Summary

The Quality Control Specialist is responsible for performing laboratory review and product release activities to ensure all raw materials, in process materials, packaging components, and finished products meet established specifications and regulatory requirements. This role plays a critical part in cGMP compliance under 21 CFR Part 111 by performing documentation review, data verification, product disposition support, and coordination with laboratory, production, and regulatory teams. The position requires strong attention to detail, analytical thinking, and the ability to manage multiple priorities in a fast-paced manufacturing environment.

Key Responsibilities

Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently abled individuals to perform the essential functions of the job.

• Review and approve raw material, in-process, and finished product documentation, including supplier Certificates of Analysis, testing report, and specification compliance, to ensure materials meet established requirements prior to release
• Perform comprehensive Batch Production Record and laboratory data review, including yield reconciliation, in-process verification, label reconciliation, and verification of calculations and test results, ensuring completeness, accuracy, and compliance with specifications and applicable test methods prior to release
• Ensure compliance with Good Documentation Practices and data integrity requirements by maintaining accurate, complete, and traceable records, including logs, release trackers, and supporting documentation
• Execute material and product disposition decisions, including approval, hold, or rejection, based on objective evidence, established specifications, and approved procedures
• Generate and issue Certificates of Analysis using verified test results and approved specifications to support product release and customer requirements
• Initiate and support investigations related to OOS, OOT, deviations, and nonconformances by performing data review, documenting findings, supporting root cause analysis, and assessing product impact, with appropriate escalation of quality issues
• Coordinate and support stability activities, including sample pulls, testing, data review, and maintenance of stability records, to ensure ongoing compliance with product specifications and shelf-life requirements
• Review supplier documentation and Certificates of Analysis to verify compliance with internal specifications and support supplier verification activities, including coordination with external laboratories and third-party testing programs
• Communicate testing status, release timelines, and quality issues to cross-functional teams, and support internal, external, and regulatory audits by providing accurate documentation and responding to information requests
• Place materials or products on hold when quality concerns are identified and execute release or rejection decisions in accordance with established procedures and quality requirements
• Provide updates to the QC Manager, escalate issues when necessary, and perform additional duties as assigned

Supervisory Responsibilities

None

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

Knowledge

Education:

• Bachelor’s degree in chemistry, biochemistry, or a related scientific field preferred
• Associate’s degree with minimum 2 years of relevant GMP experience may be considered

Experience:

• Minimum 2 years of experience in a GMP-regulated environment
• Experience with batch record review, laboratory data review, and product release activities
• Working knowledge of 21 CFR Part 111 and dietary supplement cGMP or equivalent
• Strong analytical skills, documentation accuracy, and independent decision making

Skills / Abilities

• Strong attention to detail and ability to identify discrepancies in documentation and data
• Ability to interpret technical information and make sound quality decisions within defined procedures
• Effective communication skills across cross-functional teams
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment
• Proficiency with document management systems, ERP, or similar tools

Physical Demands

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

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

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

The employee must frequently grasp, lift and/or move items 10 pounds and occasionally grasp, lift and/or move items 20lbs

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

Travel

None

Overall Work-Environment

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the 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)

Additional Information
The Salary Range for this position at Lief Labs is $28.26 - $31.00 Hourly (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.

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.