Quality Assurance Specialist
- Posted: over a month ago
The Quality Assurance Specialist interacts with all facility personnel to maintain the desired level of quality in written and electronic records, reports, and documents. They review procedures and processes for accuracy and completeness and engage in study/facility inspections. They mentor staff in the importance of quality.
DUTIES AND RESPONSIBILITIES:
- Works with the Facility Directors to develop and implement a quality assurance program and then work to ensure that quality goals are met.
- Focus on building a one quality standard within BIOQUAL, Inc. Works with management to ensure that quality is effectively established, managed, and documented in institutional policies and standard operating procedures (SOPs).
- Participates effectively in cross-functional teams to maintain and improve quality.
- Provides frequent reporting on the performance of the quality system.
- Works with management to establish and build on SOPs for equipment including standards for appropriate documentation of equipment, change control, and qualification/validation.
- Provides management of timelines and prioritization for the resolution of identified gaps.
- Develop and improve training by building administrative SOPs, quality control documents, change control documentation, maintenance, archiving, and improving processes for the handling of facility and study data.
- Establishing SOPs to ensure that computerized systems are suitable for their intended purposes and are appropriately validated, operated, and maintained as required for data integrity.
- Prepare and conduct internal and external facility inspections and site visits.
- Prepare for and respond to Sponsor audits and questionnaires
- Train staff as needed, either individually or in groups.
- Perform other duties as assigned
- QUALIFICATIONS AND SKILLS:
- Bachelor’s Degree in Biological Science
- At least 2 years of relevant job experience in a GDP/GLP/GMP regulated environment. Experience in laboratory and animal related field is preferred.
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