Quality Assurance Specialist
Company: Bioqual, Inc.
Posted on: November 18, 2022
OBJECTIVE: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 assignedQUALIFICATIONS 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.
Keywords: Bioqual, Inc., Rockville , Quality Assurance Specialist, Other , Rockville, Maryland
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