What are the responsibilities and job description for the Quality Assurance Specialist position at Collabera?
Job Summary:
The Quality Assurance Specialist I supports product quality assurance activities, process improvements, and quality system programs within a regulated manufacturing environment. This role ensures compliance with standard operating procedures and good manufacturing practices while maintaining high standards of product quality. The position involves reviewing documentation, conducting inspections, and supporting quality systems.
Key Responsibilities:
• Review production batch records for accuracy and completeness and approve materials for use in manufacturing
• Identify and report deviations and ensure proper resolution prior to approval of records
• Conduct inspections and audits of production processes to ensure compliance with procedures
• Develop and update standard operating procedures as required
• Assist in testing of complaint and stability samples and report any out-of-specification results
• Initiate and document quality incidents and support corrective action processes
• Provide support and backup to other quality team members as needed
• Support stability programs and sample retention activities
• Maintain and support electronic document control and quality tracking systems
• Perform additional quality-related duties as assigned
Required Qualifications:
• Bachelor’s degree in Chemistry, Biology, Life Sciences, or related technical field, or equivalent experience
• At least one year of experience in quality assurance or manufacturing support environment
• Knowledge of good manufacturing practices and quality systems
• Strong attention to detail and ability to follow documented procedures
• Ability to review and interpret technical documents and procedures
• Proficiency in spreadsheet and word processing tools
Preferred Qualifications:
• Experience in the medical device or regulated manufacturing industry
• Familiarity with document control systems and quality incident or CAPA systems
• Strong written and verbal communication skills
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 off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $20/hr to $30/hr
Salary : $25 - $30