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Pay Range: $24/hr to $28/hr. 

Position Details:

Job Summary:
We are seeking a detail oriented Quality Assurance Specialist II to support Quality Management System activities within a regulated manufacturing environment. The role focuses on ensuring product quality, compliance, and documentation accuracy across production processes. The candidate will be responsible for reviewing records, managing deviations, and supporting audits and change control initiatives. This position requires strong analytical skills, regulatory knowledge, and the ability to work independently. The ideal candidate will have prior experience in quality assurance within manufacturing, preferably in life sciences or medical device settings.

Key Responsibilities:

• Review production and finished goods batch records for accuracy and completeness.
• Approve intermediate and final products based on established quality standards.
• Identify, document, and follow up on deviations and quality incidents.
• Conduct spot check inspections and support internal audits.
• Write, review, and update Standard Operating Procedures and related documentation.
• Assist in validation activities and support test protocol development.
• Support complaint handling and stability sample testing and reporting.
• Maintain and manage quality system documentation and records.
• Participate in change control activities including documentation and execution.
• Support labeling updates, proofreading, and implementation.
• Train team members on quality assurance processes and procedures.

Required Qualifications:

• Bachelor degree in Chemistry, Biology, Life Sciences, or related technical field or equivalent experience.
• Minimum 3 years of experience in a Quality Assurance role within a manufacturing environment.
• Experience reviewing batch records and ensuring compliance.
• Knowledge of Quality Management Systems, deviations, and CAPA processes.
• Experience with document control systems and Standard Operating Procedures.
• Proficiency in enterprise tools such as Excel and Word.
• Ability to identify and document deviations from procedures.

Preferred Qualifications:

• Experience in medical device industry.
• Hands on experience with CAPA, calibration, or stability programs.
• Experience managing change control or design change documentation.
• Familiarity with labeling processes and regulatory compliance.
• Experience training or mentoring quality assurance staff.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)