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Cosmetic Solutions Innovation Labs · 3 months ago

Quality Assurance Specialist – Calibrations and Audits

Boca Raton, FL

Full-time

Onsite

Mid Level

3+ years exp

Cosmetic Solutions Innovation Labs is a leader in the development and manufacturing of innovative personal care products. They are seeking a Quality Assurance Specialist to manage calibration programs, ensure compliance with GMP regulations, and conduct audits to maintain high-quality standards in their operations.

Consumer GoodsCosmeticsHealth CareManufacturing

Responsibilities

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

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

Qualification

Calibration managementGMP complianceAuditing experienceRegulatory knowledgeTechnical knowledgeProblem-solving skillsCommunication skillsInterpersonal skills

Required

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

Comprehensive knowledge of industry regulations, such as GMP, GDP, 21 CFR Part 211, and relevant ISO standards

Ability to recognize compliance problems quickly and conduct root-cause analysis

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

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

A minimum of an associate's degree in a technical or scientific field is required

Preferred

Bachelor's degree preferred

Company

Cosmetic Solutions Innovation Labs

Cosmetic Solutions Innovation Labs is a globally recognized innovator, formulator, and manufacturer of scientifically proven, naturally-effective personal care products.

Founded in 1991

Boca Raton, Florida, USA

51-200 employees