Quality Specialist I

Description

Position Summary
The Quality Specialist is responsible for ensuring that personal care products meet established quality standards and comply with regulatory requirements. This role involves conducting quality sampling, inspections, audits, and various product testing, including but not limited to microbiological, analytical, organoleptic, and physical tests. Additionally, the Quality Specialist is responsible for developing and implementing quality assurance processes to ensure product safety, efficacy, and consistency.

Responsibilities and Essential Duties

• Conduct quality inspections of raw materials, in-process products, and finished goods.
• Perform routine and non-routine tests to ensure product compliance with specifications and standards.
• Monitor and analyze quality control data and test results.
• Ensure products comply with local, national, and international regulations (e.g., FDA, ISO).
• Prepare and maintain documentation required for regulatory compliance and audits
• Maintain detailed and accurate records of all testing results, comments, deviations, and control information.
• Perform root cause analysis and suggest appropriate corrective actions (OOS Investigations).
• Maintain proper labeling, handling, storage, use, and disposal of solutions, biohazard and hazardous waste, and microbiological cultures.
• Calibrate and maintain lab equipment to ensure accuracy and reliability
• Maintain laboratory inventory of items and PO requests in coordination with the QA/QC Manager.
• Support the QA/QC Manager as necessary during environmental monitoring projects.
• Strong team player with personal commitment towards business’ goals and customers’ goals.
• Perform additional duties as assigned.
   

Qualifications

Technical Skills Required

• Proficiency in serial dilutions, aseptic testing, growth promotion, microbial monitoring, gram staining, plating, membrane filtration required.
• Proficiency with HPLC and ICP-MS preferred.
• Experience with Microsoft Office Suite (Excel, Word, Outlook).
• Thorough knowledge of classical microbial culture methods (FDA-BAM, APHA, USP).
• Critical thinking and problem-solving skills are essential for this position.
• High attention to detail.
• Thorough knowledge of USP 61 and USP 62 validation and suitability studies.
• Great communication skills (oral and written).
• A basic knowledge of laboratory safety procedures and practices is required to ensure a safe working environment.

Experience Required

• 1 year relevant industry experience preferred.
• A Bachelor's degree (4-year degree) in Microbiology, Chemistry, Food Science, or a related discipline is required.
• Alternatively, 2 years of relevant experience may be considered in place of the degree requirement.

Physical Requirements

• Must be able to climb stairs, stand for long periods of time, lift up to 40 pounds and have the ability to bend.