Quality Assurance Specialist (OTC Cosmetics)

Yoh, A Day & Zimmermann Company; Carson (CA); In loco; USD 80.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Descrizione del lavoro

Yoh, A Day & Zimmermann Company is seeking a Quality Assurance Specialist (OTC Cosmetics) in El Segundo, CA. You will write SOPs, review batch records, support QMS, and ensure FDA cGMP compliance in an OTC cosmetics manufacturing environment.

Ideal candidates have 3+ years of cosmetic QA experience, direct OTC cosmetics manufacturing, and strong cross‑functional collaboration skills to work with Production, QC, R&D, Regulatory and Quality teams.

Competenze

• 3+ years of Cosmetic Quality Assurance experience in an FDA-regulated cGMP manufacturing environment.
• Direct OTC cosmetic manufacturing experience
• Hands-on experience writing SOPs, work instructions, and quality procedures from scratch
• Strong understanding of FDA OTC regulations, cGMP, GDP, USP/NF standards
• Experience supporting manufacturing-floor QA, batch documentation, product release, validation documentation, or inspection readiness

Mansioni

• Write, develop, revise, and implement SOPs, work instructions, batch records, and quality documentation from scratch as needed
• Support and maintain Quality Management System (QMS) activities in compliance with FDA cGMP regulations, including 21 CFR Parts 210, 211, 330, and 700
• Support deviations, CAPA, OOS/OOT, nonconformance, and change control processes
• Review batch production records, manufacturing documentation, analytical data, Certificates of Analysis, and related quality records
• Support product release, lot disposition, rework, reprocessing, and related QA documentation
• Provide QA support during manufacturing, compounding, packaging, labeling, and production operations
• Partner cross‑functionally with Production, QC, R&D, Regulatory, Warehouse, and other teams to resolve documentation, manufacturing, and quality issues
• Assist with internal audits, customer audits, FDA inspection readiness, audit responses, and CAPA follow‑up
• Ensure compliance with FDA, USP, ICH, cGMP, GDP, and internal quality standards applicable to OTC drug and cosmetic products
• Support validation documentation and review, including equipment, process, cleaning, and related protocols/reports
• Maintain controlled documents, records, training files, and quality documentation in accordance with cGMP and data integrity requirements
• Develop and deliver training related to SOPs, cGMP, GDP, quality procedures, and manufacturing documentation practices
• Support Product Quality Reviews, trend analysis, quality metrics, and continuous improvement initiatives
• Assist with calibration, preventive maintenance, equipment qualification, and environmental/utility documentation as needed
• Stay current with applicable FDA, USP, ICH, and OTC/cosmetic regulatory requirements and support quality system updates accordingly

Conoscenze

Quality Assurance

Documentation

SOP Writing

Cross-functional Collaboration

FDA cGMP

Batch Record Review

Formazione

Bachelor’s degree in Chemistry, Biology, Pharmacy, Life Sciences

Cosmetics/OTC manufacturing experience

Descrizione del lavoro

Yoh is hiring a Quality Assurance Specialist (OTC Cosmetics) for our client in the personal care / OTC cosmetics manufacturing industry. In this role, you will support quality systems, documentation, batch record review, SOP development, deviations, CAPA, audit readiness, and cGMP compliance within an FDA-regulated OTC manufacturing environment. This is a hands‑on QA role ideal for someone with direct OTC/cosmetics manufacturing experience who can write SOPs from scratch, support manufacturing quality activities, and work cross‑functionally with Production, QC, R&D, and Regulatory teams.

Industry: OTC / Cosmetics Manufacturing

Location: El Segundo, CA

Job Functions

• Write, develop, revise, and implement SOPs, work instructions, batch records, and quality documentation from scratch as needed
• Support and maintain Quality Management System (QMS) activities in compliance with FDA cGMP regulations, including 21 CFR Parts 210, 211, 330, and 700
• Support deviations, CAPA, OOS/OOT, nonconformance, and change control processes
• Review batch production records, manufacturing documentation, analytical data, Certificates of Analysis, and related quality records
• Support product release, lot disposition, rework, reprocessing, and related QA documentation
• Provide QA support during manufacturing, compounding, packaging, labeling, and production operations
• Partner cross‑functionally with Production, QC, R&D, Regulatory, Warehouse, and other teams to resolve documentation, manufacturing, and quality issues
• Assist with internal audits, customer audits, FDA inspection readiness, audit responses, and CAPA follow‑up
• Ensure compliance with FDA, USP, ICH, cGMP, GDP, and internal quality standards applicable to OTC drug and cosmetic products
• Support validation documentation and review, including equipment, process, cleaning, and related protocols/reports
• Maintain controlled documents, records, training files, and quality documentation in accordance with cGMP and data integrity requirements
• Develop and deliver training related to SOPs, cGMP, GDP, quality procedures, and manufacturing documentation practices
• Support Product Quality Reviews, trend analysis, quality metrics, and continuous improvement initiatives
• Assist with calibration, preventive maintenance, equipment qualification, and environmental/utility documentation as needed
• Stay current with applicable FDA, USP, ICH, and OTC/cosmetic regulatory requirements and support quality system updates accordingly

Education, Licensure and/or Experience

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Life Sciences, or related scientific discipline preferred; equivalent relevant experience may be considered
• 3+ years of Cosmetic Quality Assurance experience in an FDA-regulated cGMP manufacturing environment
• Direct OTC cosmetic manufacturing experience
• Cosmetics, personal care, topical, skincare, or contract manufacturing experience
• Hands‑on experience writing SOPs, work instructions, and quality procedures from scratch required
• Experience with deviations, CAPA, OOS/OOT, nonconformance investigations, batch record review, and audit preparation
• Strong understanding of FDA OTC regulations, cGMP, GDP, USP/NF standards, and quality documentation practices
• Experience supporting manufacturing‑floor QA, batch documentation, product release, validation documentation, or inspection readiness
• Strong communication skills and ability to work cross‑functionally with Production, QC, R&D, Regulatory, and Quality teams
• Ability to work in a hands‑on, fast‑paced manufacturing environment with strong attention to detail

Estimated Min Rate: $80,000.00

Estimated Max Rate: $85,000.00

What’s In It for You?

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Equal Opportunity Employer

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.