Qa specialist [h1.location_city]

Job Description

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 formulization, graphic design, manufacturing, packaging and delivery.

Job Title : Quality Assurance Specialist – Supplier Quality

Location : United States (On-site, CDMO Manufacturing Facility)

Reports to : Quality Director

Position Summary

The Quality Assurance Specialist – Supplier Quality is responsible for managing all aspects of supplier quality and compliance within a cosmetics and topical over-the-counter (OTC) pharmaceutical contract development and manufacturing organization (CDMO). This role oversees supplier qualification, monitoring, and disqualification to ensure compliance with applicable regulatory standards, including FDA, ISO, and cGMP requirements. The position works cross-functionally with Procurement, Manufacturing, R&D, and Quality departments to ensure that all suppliers consistently meet quality, safety, and regulatory expectations.

Key Responsibilities

Supplier Quality Management

Lead all aspects of supplier quality oversight, including onboarding, qualification, routine monitoring, and disqualification or exit.

Evaluate and qualify suppliers across multiple categories :  raw materials / ingredients, packaging components, printed materials, testing laboratories, and GMP service providers.

Develop and maintain the Approved Supplier List (ASL) to ensure alignment across Procurement, R&D, and Operations.

Perform supplier risk assessments and maintain supplier performance metrics and trend analyses for management review.

Ensure supplier documentation and records comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Auditing & Compliance

Plan and execute supplier audits (on-site and remote) to assess adherence to regulatory and internal quality standards (e.g., 21 CFR Part 211, ISO 9001, ISO 22716, ISO 17025).

Manage audit schedules, reports, corrective and preventive actions (CAPAs), and Supplier Corrective Action Requests (SCARs).

Review and approve supplier change notifications, assessing potential impact on product quality and regulatory compliance.

Maintain supplier certifications and registrations (e.g., ISO, FDA, state-level registrations) and ensure timely renewals.

Quality Systems Oversight

Manage supplier-related quality agreements, quality risk assessments, monitoring reports, and change control activities.

Support and lead supplier-related investigations and root cause analyses for deviations and nonconformances.

Participate as a subject matter expert (SME) during internal audits, client audits, and health authority inspections.

Ensure continuous improvement of supplier quality programs by analyzing performance data and driving process optimization initiatives.

Cross-Functional Collaboration

Partner with R&D, Manufacturing, Regulatory Affairs, Procurement, and Quality Control to ensure supplier capabilities align with product and regulatory requirements.

Support the raw material approval program, ensuring appropriate testing, documentation, and qualification are in place prior to use.

Regulatory Awareness & Continuous Improvement

Stay informed on current regulatory trends, agency inspection findings (e.g., FDA Warning Letters), and evolving global standards affecting supplier quality management.

Recommend and implement improvements to strengthen supplier oversight and ensure compliance with emerging industry best practices.

Qualifications & Experience

Experience :  A High School Diploma or GED with 10 years’ experience or an associate or bachelor’s degree with 3–5 years of experience in Quality Assurance or Supplier Quality, ideally within a regulated cosmetics, OTC drug, personal care, food / supplement, or medical device environment.

Regulatory Knowledge :  Working knowledge of 21 CFR Parts 210 / 211, ISO 9001, ISO 22716 (Cosmetic GMPs), and ISO 17025 requirements.

Technical Skills :  Proficient in conducting supplier audits, risk assessments, CAPA management, and data-driven quality reporting. Experienced in AQL (Acceptable Quality Level) sampling inspection techniques; AQL certified preferred.

Analytical Skills :  Strong ability to identify compliance issues, perform root cause analysis, and implement effective corrective actions.

Communication :  Excellent verbal and written communication skills, with the ability to clearly convey technical and regulatory information to internal teams and suppliers.

Soft Skills :  Strong interpersonal and organizational skills; able to work independently, manage multiple priorities, and maintain confidentiality.

System Experience :  Familiarity with Quality Management Systems (QMS), document control systems, and supplier management databases preferred.

Education

Minimum :  High School Diploma or GED

Preferred :  Associate’s or Bachelor’s degree in a scientific, engineering, or quality-related discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences, or Quality Management).

Additional Information

This position may require occasional domestic and international travel to perform supplier audits and assessments.

Candidates should be comfortable working in a fast-paced, highly regulated CDMO environment supporting both cosmetics and OTC pharmaceutical clients.

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.