Job Title: Quality Control Technician

Overview:
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.

  • 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 escalate 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.
  • 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.
  • High School or equivalent.
  • 0 - 2 years of experience in quality assurance or control.
  • Knowledgeable in GMP’s, OTC/Cosmetic manufacturing and packaging preferred.
  • Bilingual preferred.

*Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

*Equal Opportunity Employer