Quality Assurance Specialist

Posted 9 Days Ago
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Boca Raton, FL, USA
In-Office
Mid level
Beauty • Manufacturing
The Role
Ensure GMP compliance and maintain the QMS/eQMS. Lead CAPA and deviation investigations, manage document control and SOPs, perform audits/inspections, review and track work orders and labels, send FG samples to lab, and drive continuous quality improvements in alignment with 21 CFR Parts 210/211.
Summary Generated by Built In

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:

 

1. 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.

2. 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.

3. 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.

4. Deviations Management:

  • Investigate deviations from established procedures and specifications.
  • Develop and implement corrective actions to address deviations and prevent recurrence.

5. 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.

 

6. 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.

 

7. 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.

Skills Required

  • Previous experience working in a manufacturing environment
  • Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (FDA, ISO)
  • Experience with quality systems management, CAPAs, deviations, document control, and SOPs
  • Ability to lead investigations, develop CAPA plans, and monitor effectiveness
  • Experience conducting GMP audits and inspections
  • Experience with eQMS administration or electronic quality systems
  • Excellent analytical and problem-solving skills
  • Effective communication and collaboration; ability to read, write, and speak English
  • Detail-oriented with a commitment to quality and compliance
  • Bachelor's degree in a related field (Quality Assurance, Chemistry, Biology, Engineering)
  • Knowledge of 21 CFR Parts 210/211
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The Company
17 Employees
Year Founded: 1991

What We Do

Cosmetic Solutions is a globally recognized manufacturer of turnkey private label skincare and a leader in the custom formulation of scientifically-proven, naturally-effective personal care products. Based in Boca Raton, Florida, the company specializes in the research, development, and production of innovative, performance skincare, beauty, and wellness products, providing custom formulation and contract manufacturing services to a variety of global beauty brands.

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