Quality Assurance Specialist

Cosmetic Solutions Innovation Labs; Boca Raton (FL); On-site; USD 55,000 - 85,000; Full time

Job summary

Cosmetic Solutions is seeking a Quality Assurance Specialist to uphold GMP standards and drive continuous improvement across manufacturing operations. The role involves leading CAPA investigations, managing the QMS, and collaborating with cross-functional teams to ensure regulatory compliance and product quality.

The ideal candidate will have a strong GMP background, experience with deviations, document control, and SOP development, with excellent analytical and communication skills in English.

Qualifications

• Minimum experience in manufacturing within a regulated industry (pharma/medical devices/food).
• Strong GMP knowledge and regulatory familiarity (FDA, ISO).
• Experience with quality systems management, CAPAs, deviations, document control, and SOPs.

Responsibilities

• Ensure GMP compliance across manufacturing processes and audits.
• Maintain and improve the Quality Management System (QMS).
• Lead CAPA investigations, develop corrective actions, and track effectiveness.
• Investigate deviations from procedures and implement corrective actions to prevent recurrence.
• Manage document change control and maintain repositories.
• Collaborate with sales, manufacturing and supply chain to address quality concerns.
• Review batch cards and work orders, and ensure SDS documentation where required.
• Review production schedules for accuracy and updates.
• Develop, review, and update SOPs to reflect best practices and regulatory requirements.
• Provide training and support on quality processes.
• Progress toward SME role and ownership of key quality programs (APR/PQR, supplier qualification, eQMS).

Skills

GMP compliance

Regulatory knowledge

Quality systems

CAPA management

SOP development

Document control

English communication

Education

Bachelor's degree in related field (Quality Assurance, Chemistry, Biology, Engineering)

Job description

Who we are:

Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market.

Providing world class services to up and coming businesses, large established brands, physicians, estheticians and other skin care professionals; we specialize in research & development, custom formulation, graphic design, manufacturing, packaging and delivery.

Job Title: Quality Assurance Specialist

Organizational Relationships

Reports to:

• QA Manager

Supports:

• QA/QC, Operations, Sales

Responsibilities will include, but are not limited to:

• Good Manufacturing Practices (GMP):
• Ensure Compliance with GMP regulations throughout the manufacturing process.
• Conduct regular audits and inspections to verify adherence to GMP standards.
• Develop and implement strategies to continuously improve GMP compliance.
• Quality Systems Management:
• Maintain and improve the company’s quality management system (QMS).
• Identify areas for process improvement and implement effective quality control measures.
• Collaborate with cross-functional teams to ensure alignment with quality objectives.
• Corrective and Preventative Actions (CAPAs):
• Lead investigations into quality issues and non-conformances.
• Develop CAPA plans to address root causes and prevent recurrence of quality issues.
• Monitor and track the implementation of CAPAs to ensure effectiveness.
• Deviations Management:
• Investigate deviations from established procedures and specifications.
• Develop and implement corrective actions to address deviations and prevent recurrence.
• Document Control:
• Ensure the accuracy, completeness, and integrity of quality-related documentation.
• Manage document change control processes and maintain document repositories.
• Lead root cause investigations for quality issues and customer complaints, implementing corrective and preventive actions.
• Work cross-functionally with sales, manufacturing and supply chain teams to address quality concerns that could affect customer satisfaction or regulatory compliance.
• Enter scanned work orders into the tracking system.
• Review batch cards and log into tracker.
• Review finished goods work orders and update tracker.
• Send finished goods (FG) samples to the laboratory.
• Print and review finished goods work orders.
• Attach green status stickers to bulk material.
• Review and approve labels for work orders.
• Verify that all work orders include the required SDS documentation.
• Review the production schedule for accuracy and updates.
• Standard Operating Procedures (SOPs):
• Develop, review, and update SOPs to reflect current best practices and regulatory requirements.
• Ensure SOPs are followed consistently throughout the organization.
• Provide training and support to employees on SOPs and quality processes.
• Subject Matter Expertise & Program Ownership (Progressive Responsibility):
• Over time, the Quality Assurance Specialist will develop into a Subject Matter Expert (SME) and assume ownership of key Quality Systems programs in alignment with 21 CFR Parts 210/211. Core areas include Annual Product Reviews (APR/PQR), Supplier Qualification, eQMS administration and internal audit/inspection readiness. The role is expected to drive continuous improvement through quality metrics trending, training support, and ensuring sustained GMP compliance across operations.

Experience:

• Previous experience working in a manufacturing environment, preferably in a regulated industry (e.g., pharmaceuticals, medical devices, food).
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO).
• Experience with quality systems management, CAPAs, deviations, document control, and SOPs.
• Excellent analytical and problem-solving skills.
• Effective communication and collaboration abilities. Must be able to read, write, and speak in English.
• Detail-oriented with a commitment to quality and compliance.

Education:

• Bachelors degree in a related field preferred (e.g., Quality Assurance, Chemistry, Biology, Engineering).

Equal Employment Opportunity

Cosmetic Solutions 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, or protected veteran status and will not be discriminated against on the basis of disability.