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Audit Heavy Quality Assurance Associate
Posted Friday, July 14, 2023
Posting ID: JP-003906966
• 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.
o First article inspections
o In-process release inspection.
o Final QC release of finished goods.
o 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.
Education/Training: Bachelor's degree in a technical or scientific skill, or High School Diploma with 1-3 years of experience in quality assurance.
• 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.
• Experienced in the areas of the Quality System including 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 attributes: integrity and trust, work ethic, sound judgment, pragmatism, courage
• 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.
labeling, batch records, GDP, GMP, documentation, quality, inspection, deviation, attention to detail, document control, bachelors