Quality Control Technician
Sombra USA
The Quality Control Technician will work in the quality control unit, support manufacturing processes, and report to the Director of Quality. The role requires production environment support for in-process and finished product inspections and final batch record review. Duties In process review and final review of batch records and associated forms. Label approval and incoming inspections of components and Raw Materials. Engage in Document Control and maintain Controlled Documentation compliance by assisting in SOP reviews, change control, training and document approvals. Quality control oversight to ensure cGMP compliance within manufacturing, warehouse and distribution facility areas. Assist with validation and qualification activities. Perform initiation, investigations, root-cause analysis and disposition activities per investigation processes. Ability to accelerate quality concerns, perform procedures independently, and notify leadership if deviations are identified. Perform Internal Quality Audit to continuously monitor process compliance and engage in audit readiness. Continuously aid in identifying areas of improvement in process and compliance. Other duties as assigned by the Director of Quality. Experience Time management and excellent communication skills, both written and verbal, and be able to communicate clearly with personnel. Must understand quality tools such as design controls, quality system auditing, inspection methods, statistical sampling plans, verification and validation requirements. Must have experience in technical documentation methods (e.g., laboratory notebook). Ability to apply critical-thinking and escalations when nonconformance or deviations arise within a process. Demonstrate ownership for the integrity of work. Strong written and verbal communications. Qualifications High School or equivalent. 0 - 2 years of experience in quality assurance or control. Knowledgeable in GMP’s, OTC/Cosmetic manufacturing and packaging preferred.
- Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
- Equal Opportunity Employer
$19 - $20 per hour
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