Quality Assurance Specialist
Company: Quest Staffing Services, Inc.
Posted on: May 9, 2022
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
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
Participate in the management of equipment, process and software
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.
Ensures that all inspections and procedures are properly completed
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
Participates on investigation of source materials for products and
Responsible for completing customer surveys and questionnaires.
Education/Training: Bachelor's degree in a technical or scientific
skill, or High School Diploma with 0-3 years of experience in
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
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
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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