Quality Assurance Specialist - Calibrations and Audits

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 – Calibrations and Audits Organizational Relationships Reports to: * Quality Assurance Director Supports:

• Manufacturing
• Facilities
• Quality Assurance

Responsibilities will include, but are not limited to:

CALIBRATIONS / PEST CONTROL

• Calibration program management: manage calibration system spreadsheet, schedule calibrations with 3rd party vendors, and communicate with 3rd party vendors about failures, repairs, and trends of equipment.
• Create POs in systems like NetSuite for approved calibration quotes and coordinate execution of services.
• Documentation and compliance: Maintain complete records of all calibration, maintenance, and repairs in compliance with regulations like Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Standard Operating Procedures (SOPs): Read, follow, and potentially write or revise calibration-related SOPs for new and existing equipment.
• External vendor management: Coordinate with 3rd party vendors for specialized calibration services or repairs that are not performed in-house.
• Approve 3rd party calibration companies and equipment vendors via supplier qualification and audit procedure.
• Technical knowledge: Strong understanding of calibration principles and proficiency with calibration standards, instruments, and software.
• Investigate and resolve major instrument-related issues and out-of-tolerance (OOT) reports.
• Analyze calibration data to identify trends, improve measurement processes, and minimize equipment downtime.
• Deviation and corrective action: Investigate and troubleshoot equipment that fails calibration. This includes documenting "out of tolerance" findings, participating in non-conformance reports, and implementing Corrective and Preventive Actions (CAPA).
• Act as a technical liaison between calibration, maintenance, quality, and other departments.
• Create metrics to monitor instrument performance and analyze trends.
• Participate in site-wide shutdown meetings and lead calibration projects.
• Preventive maintenance (PM) and repair: Manage the preventative maintenance (PM) programs for facility equipment (water system, analytical devices, manufacturing equipment) where applicable.
• Coordinate repairs of equipment as needed to minimize downtime and ensure reliable performance.
• Initiate and manage Change Controls to document modifications to instruments, processes, or calibration procedures.
• Enter calibration results and metadata into the Master Calibration Log; assign ID numbers and labels to new instruments and ensure scheduling of calibration services.
• Monitor the ISO certification status of calibration vendors.
• Audits: Participate in internal and external audits by regulatory agencies, acting as a subject matter expert for all metrology-related documentation.
• Pest control program management: manage the company pest control program in all company locations (Boca Raton and Pompano Beach) to include scheduling pest control visits on a regular and as-needed basis, maintain all records and pest control activities in compliance with regulations like Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Standard Operating Procedures (SOPs): Read, follow, and potentially write or revise SOPs pertaining to pest control program. Maintain a pest control binder that includes a facility map, a list of chemicals used, and applicable company licenses.
• Escort pest control and calibration service providers.
• Conduct and document monthly and quarterly facility inspections at Boca and Pompano; identify and escalate any hygiene, facility condition, or pest risks.

AUDITS

• Plan and conduct GMP and GxP audits: Perform audits of manufacturing facilities, internal laboratories, and warehouse/shipping operations to ensure compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• Identify risks: Analyze manufacturing processes to identify potential vulnerabilities, control gaps, and inefficiencies.
• Provide recommendations: Prepare and present audit reports detailing findings, identify root causes, and make recommendations for corrective and preventive actions (CAPA) to management and the audit committee.
• Manage remediation: Follow up on audit findings to ensure that impacted departments and management have implemented corrective and preventive action plans effectively.
• Monitor regulatory trends: Stay informed about current regulatory trends, agency findings (e.g., FDA warning letters), and changes to regulations that should be reflected in company operations.
• Support external audits and inspections: Assist in preparing the company for audits and inspections by clients, health authorities, or other regulatory bodies (FDA, DBPR, ISO).
• Review quality systems: Evaluate the quality management system to ensure adherence to company standards and to drive continuous improvement in processes.
• Audit IT systems: Assess the security and control of information technology systems, including data integrity, cybersecurity measures, and electronic records.
• Examine training records of audited departments to ensure employee qualifications are current, identify gaps in required training, and verify compliance with regulatory and internal requirements.
• Provide training: Educate and train internal staff in audit, compliance, and inspection techniques.

Experience:

• 3-5 years of experience in calibration or metrology, preferably within a regulated industry like drug, food/supplement, or medical devices.
• 3-5 years of experience in auditing, preferably within a regulated industry like drug, food/supplement, or medical devices.
• Regulatory knowledge: Comprehensive knowledge of industry regulations, such as GMP, GDP, 21 CFR Part 211, and relevant ISO standards.
• Problem-solving skills: Ability to recognize compliance problems quickly and conduct root-cause analysis.
• Communication skills: Strong written and verbal communication to explain technical information and document findings in reports. Strong written and verbal communication skills in English are essential for this role.
• Soft skills: Ability to work within groups to accomplish goals. Interpersonal skills are necessary for effective interviewing, investigation, and reporting. The ability to work independently, manage multiple priorities, and maintain discretion with confidential information is also critical.

Education: * A minimum of an associate's degree in a technical or scientific field is required. Bachelor’s degree preferred. 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. Employee Acknowledgement:

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