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Description

Job Title: Data Entry Clerk - Quality Systems

Location: Tustin, CA - Onsite
Schedule: Full Time
Department: Quality Assurance / Regulatory Affairs
Reports to: Chief Regulatory Officer

About Us

BioPhotas, Inc., makers of Celluma Light Therapy, is a global leader in non-invasive, award-winning LED light therapy solutions for medical, wellness, and aesthetic markets. With FDA clearances and CE marks, BioPhotas' mission is to improve health and wellness through safe, effective light-based innovations used by professionals and consumers worldwide.

Job Summary

The Data Entry Clerk - Quality Systems, supports the Quality Assurance function by accurately entering, maintaining, and verifying quality-related records within the company's Quality Management System (QMS). This role is critical to ensuring data integrity, traceability, and compliance with medical device regulatory requirements. The position requires a high degree of accuracy, attention to detail, and adherence to controlled procedures.

Key Responsibilities

• Accurately enter and update quality records in electronic QMS databases and spreadsheets
• Verify data accuracy, completeness, and consistency in accordance with approved procedures
• Identify and report data discrepancies, errors, or missing information to Quality personnel
• Maintain document control practices, including version control and record retention
• Handle confidential and regulated information in compliance with company policies and regulatory requirements
• Support Quality Assurance staff with administrative and clerical tasks as needed
• Follow all applicable Quality System procedures and work instructions

Working Conditions

• Office-based, on-site role
• Prolonged periods of computer and desk work
• Interaction with Quality, Regulatory, and Operations teams
• Must comply with company policies related to data security and document control

Pay Range: $23.50 to $26.00 per hour, non-exempt

An employee's pay position within the range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, performance, revenue-based metrics, any contractual agreements, and business or organizational needs. 

Benefits:

BioPhotas believes in the power of wellness and offers a comprehensive benefits package to our employees, including:

• 401(k) plan with company match
• Paid time off and company holidays
• BioPhotas pays 100% of employee-only premiums for medical, dental & vision plans, with premium sharing options to add dependents 
• HSA - with employer contributions 
• Healthcare & Dependent Care FSA
• Life & Disability Insurance
• Wellness program
• Employee Assistance Program 

BioPhotas provides equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification in accordance with federal EEOC and California's Fair Employment & House Act (FEHA). BioPhotas is dedicated to the fulfillment of this policy regarding all aspects of employment, including, but not limited to, recruiting, hiring, training, promotion, rates of pay, leaves of absence, termination, and all other terms, conditions, and privileges of employment. 

BioPhotas does not accept unsolicited assistance or resumes/CVs from third party search firms. 

Requirements

Required Qualifications

• High school diploma or equivalent
• Previous experience in data entry, clerical, or administrative roles
• Strong attention to detail and accuracy
• Basic proficiency with Microsoft Office (Excel, Word, Outlook)
• Ability to follow written procedures and instructions precisely
• Ability to work independently in a structured, regulated environment
• Strong organizational and time-management skills

Preferred Qualifications

• Experience in medical devices, pharmaceuticals, or other regulated industry
• Familiarity with Quality Management Systems (QMS) or electronic QMS tools
• Basic understanding of ISO 13485, FDA Quality System Regulation (QSR), or similar standards
• Experience handling controlled documents or quality records

Skills & Competencies

• High level of data integrity and attention to detail
• Understanding of the importance of compliance and traceability
• Ability to manage repetitive tasks without loss of accuracy
• Professional discretion when handling confidential information
• Clear written and verbal communication skills