Audit Heavy Quality Assurance Associate

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.

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.

Preferred Skills:

Education/Training: Bachelor's degree in a technical or scientific skill, or High School Diploma with 1-3 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.

• 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.

Skills:

labeling, batch records, GDP, GMP, documentation, quality, inspection, deviation, attention to detail, document control, bachelors