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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.
Job Responsibility:
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
Requirements:
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
Nice to have:
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
What we offer:
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)