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Quality Assurance Specialist II

Oceanside, CA 92058

Posted: 01/16/2023 Employment Type: Direct Placement Category: Quality Job Number: 95936

Job Description

Position Title: Quality Assurance Specialist II
Reporting to: QA Assistant Manager

Summary of Job:
The Quality Assurance Specialist II is a crucial role in conducting all aspects of Quality Assurance within our assigned business project portfolio. He/she is responsible for managing, coordinating, facilitating and implementing quality assurance standards based on ICH and ISO requirements across all our products. The incumbent in this position directs quality assurance methods, develops and controls quality programs, monitors production conformance with QA standards and procedures as well as participates in creating methods for improving product quality.
Specific Duties and Responsibilities:
  • Participate in the development, implementation, management and integration of a Quality Management System (QMS) for all our production activities and products.
  • Review and release the document packages (including batch record, CoA and other related documents) for each company product lot.
  • Review and release the document packages for raw materials and packaging components
  • Participate in the initiation, documentation, and management of quality events (e.g.: deviations, CAPA, change control, complaints).
  • Assist in the design, implementation and documentation of procedures for process control, process improvement, testing and inspection.
  • Assist in root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements.
  • Report to management on quality issues, trends and losses.
  • Participate in internal and external quality audits.
  • Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
  • Serve as secondary contact for order fulfillment related activities and other QA Specialist I responsibilities as needed.
  • Serve as a trainer for other QA personnel as needed
  • Other duties as assigned or identified.

Requirements:
  • Bachelor’s degree in Science or equivalent work experience.
  • Experience (3-4 years) working in a GXP or ISO regulated environment.
  • Experience (1-2 years) in a Quality Assurance related role
  • Must have excellent skills in organization, negotiation, problem solving and time-management.
  • Able to attend to detail and act decisively.
  • Ability to work under pressure, manage several tasks at once and meet tight deadlines.
  • Must have excellent interpersonal, written, oral presentation and verbal communication skills.
  • Proficient in Microsoft Word, PowerPoint, Access and Excel.

Physical Job Requirements:
Office/Lab environment. Lifting up to 50 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
Disclaimer: This job description reflects management’s assignment of essential job duties; and nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Compensation
  • $25 to $37 Hourly
Benefits Offered
  • 401K, Dental, Life, Medical, Vision
Employment Type
  • Full-Time

P-OCE-3
 
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