Quality and Regulatory Specialist

Job Overview

The Quality Specialist supports the effective implementation, maintenance, and continuous improvement of PakLab’ s Quality Management System (QMS). This role is responsible for ensuring that company operations, documentation, and product-related activities consistently meet internal quality standards, customer expectations, and applicable regulatory and Good Manufacturing Practice (GMP) requirements. This position supports all quality system processes including but not limited to internal audits, deviation and nonconformance tracking, corrective and preventive actions (CAPA), change control, training documentation, external, and supplier audit. The Quality Specialist assists in monitoring compliance through routine review of quality data, participation in inspections and audits, and follow-up on all committed actions to ensure timely and effective resolution to the identified issues. The role works cross-functionally with Operations, Production, Regulatory, R&D, and Supply Chain teams to help maintain compliance, support investigations, resolve quality issues, and ensure that quality considerations are appropriately integrated into operational processes. The Quality Specialist is expected to help communicate quality requirements clearly and support teams in understanding and adhering to established procedures and regulatory expectations.I. Essential Duties and

Responsibilities

• Maintain and update quality system documentation, including SOPs, work instructions, and records.
• Support internal audit programs by preparing schedules, conducting audits, and documenting findings.
• Support external audits by preparing, staging, and follow up on committed actions.
• Assist with supplier qualification, monitoring, and audits.
• Review of CAPA records, deviation reports, Nonconformance records, and change controls for accuracy and compliance.
• Support investigations of non-conformances, customer complaints, and product quality issues.
• Assist with CAPA (Corrective and Preventive Actions) development, implementation, and verification.
• Track and report quality metrics and performance trends to direct management.
• Participate in training and onboarding of employees on GMP, quality procedures, and compliance requirements.
• Ensure compliance with applicable GMP, FDA, ISO, and customer-specific requirements.
• Support preparation for customer and regulatory audits, including FDA and ISO.
• Identify opportunities for process improvements and contribute to continuous improvement initiatives.
• Perform other duties as assigned.

Required Skills and Abilities

• Strong knowledge of GMP, quality systems, and regulatory compliance requirements.
• Excellent organizational, recordkeeping, and documentation control skills.
• Strong analytical and problem-solving skills with attention to detail.
• Effective communication and collaboration skills across departments.
• Proficiency in Microsoft Office Suite and experience with quality management systems (QMS).
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Experience in a high traffic Contract manufacturer preferred.

Education and Experience Requirements

• Bachelor’s degree in Quality, Life Sciences, Engineering, or related field preferred.
• 3–5 years of hands-on quality assurance and quality systems experience in a manufacturing environment.
• Experience in cosmetics, pharmaceuticals, or consumer packaged goods preferred.
• Experience supporting audits and compliance programs required.

Working Conditions and Physical Demands

• Work performed in both office and manufacturing environments.
• Exposure to noise, machinery, chemicals, and production materials when on the production floor.
• Flexibility to work extended hours, weekends, or shifts to meet business needs and audit schedules.
• Prolonged periods of sitting at a desk and working on a computer.
• Frequent walking and standing on the production floor.
• Ability to lift up to 25 pounds occasionally.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.

Equal Employment Opportunity (EEO) Statement

Universal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

Pay: $57,600.00 - $66,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Work Location: In person