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Quality Assurance Specialist

Company: Quest Staffing Services, Inc.
Location: Camarillo
Posted on: May 9, 2022

Job Description:

Job Description Position Summary: Collaborate with stakeholders to the management of the Quality System. Maintain, recommend and implements changes to the existing quality system with regards to nonconforming product, corrective/preventive actions, document control, quality control inspections and product release, internal audits, validations and equipment calibration and maintenance programs.
Responsibilities :
Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements;
Conducts audits and reviews/analyzes data and documentation.
Responsible for the change control program
Initiate, investigate and complete nonconformance reports (NCR). Participate in the MRB meetings.
Responsible for facilitation of document control and training programs
Participate in the management of equipment, process and software validation.
Manage the equipment calibration and maintenance program. Maintain the inventory and status of measuring devices.
Provide help and support for all aspects of testing related to manufacturing. First article inspections
In-process release inspection.
Final QC release of finished goods.
Document review

Ensures that all inspections and procedures are properly completed and documented.
Supports the environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures.
Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
Participates on investigation of source materials for products and components.
Responsible for completing customer surveys and questionnaires.
Preferred Skills:
Education/Training: Bachelor's degree in a technical or scientific skill, or High School Diploma with 0-3 years of experience in quality assurance.
Experience :
Understanding of global pharmaceutical product regulations with experience with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
Minimum of 0-3 years' experience with technical documentation for quality activities. This experience should be in the areas of the Quality System that includes corrective actions, change control, quality audits and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.
Solid organizational and planning skills required.
Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
Must be able to work effectively and efficiently in a team environment.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Must have passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuously improve.
Must have uncompromising dedication to quality.
Good general mathematical skills.
General computer skills.

Keywords: Quest Staffing Services, Inc., Camarillo , Quality Assurance Specialist, Other , Camarillo, California

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