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
TheQuality Assurance Specialist Supplier Qualityis responsible formanaging all aspects of supplier quality and compliance within acosmetics and topicalover-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 includingFDA ISO and cGMPrequirements. 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 andmaintaintheApproved Supplier List (ASL)to ensure alignment across Procurement R&D and Operations.
Perform supplier risk assessments andmaintainsupplier performance metrics and trend analyses for management review.
Ensure supplier documentation and recordscomply withGood Manufacturing Practices (GMP)andGood 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 ensuretimelyrenewals.
Quality Systems Oversight
Manage supplier-related quality agreements quality risk assessmentsmonitoringreports and change control activities.
Support and lead supplier-related investigations and root cause analyses for deviations and nonconformances.
Participate as asubject 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 withR&D Manufacturing Regulatory Affairs Procurement and Quality Controlto ensure supplier capabilities align with product and regulatory requirements.
Support theraw 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 emergingindustrybest practices.
Qualifications & Experience
Experience:A High School Diploma or GED with 10 years experience or anassociate or bachelorsdegree with35 years of experience inQuality Assurance or Supplier Quality ideally within aregulated cosmetics OTC drug personal care food/supplement or medical deviceenvironment.
Regulatory Knowledge:Working knowledge of21 CFR Parts 210/211ISO 9001ISO 22716 (Cosmetic GMPs) andISO 17025requirements.
Technical Skills:Proficient in conducting supplier audits risk assessments CAPA management and data-driven quality reporting. Experienced inAQL (Acceptable Quality Level) sampling inspection techniques;AQL certifiedpreferred.
Analytical Skills:Strong ability toidentifycompliance 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 andmaintainconfidentiality.
System Experience:Familiarity with Quality Management Systems (QMS) document control systems and supplier management databases preferred.
Education
Minimum:High School Diploma or GED
Preferred:Associates or Bachelorsdegree in a scientific engineering or quality-related discipline (e.g. Chemistry Biology Pharmaceutical Sciences or Quality Management).
Additional Information
This position may requireoccasional domestic and international travelto perform supplier audits and assessments.
Candidates should be comfortable working in afast-paced highly regulated CDMO environmentsupporting both cosmetics and OTC pharmaceutical clients.
Equal Employment Opportunity
Cosmetic Solutions is an equalopportunityemployer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran statusand will not be discriminated againston the basis ofdisability.
Required Experience:
IC
Who we are: Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, f...