Quality Research Associate
Company: BTS Research
Location: San Diego
Posted on: November 25, 2022
BTS Research a well-established, diverse, stable yet growing CRO
in beautiful San Diego is seeking a highly motivated, detail
orientated, well organized, and skilled Quality Research Associate
who loves overcoming challenges, enjoys creating and maintaining
positive team relationships and shares our passion for innovation,
quality work and producing results that will continue to lead BTS
to the next level.The duties presented are only a summary of
duties. The Quality Research Associate professionals serve as key
members of the Compliance Team and activities in all of our
facilities therefore a individuals of high integrity. In general
the QRA I ensure compliance with company policies, SOP's, GLP,
quality assurance program, safety and environmental standards, and
regulatory agencies (i.e. FDA, DEA, San Diego County, EPA,
OSHA).Duties & Responsibilities include:
- GLP Compliance (as a member of the Quality Assurance Unit)
- Review non-clinical study protocols (GLP and non-GLP).
- Perform critical phase audits, raw data audits and final report
review for GLP studies.
- Ensure personnel are trained and qualified prior to
participation in GLP study.
- Support in the facility inspections to ensure GLP
- Maintain the BTS SOP and Forms systems, including review,
revisions issuance, and intranet uploads.
- Create and modify documents (SOPs, Forms) using Microsoft
- Perform Quality Control on study specimens and samples prior to
- Assist in investigating and closing CAPAs.
- Ensure non-clinical studies are archived in a timely
- Equipment Management
- Maintains BTS Asset Inventory List.
- Assigns asset numbers to all incoming equipment.
- Ensures that the asset numbers have equipment files and
- Ensures that equipment is calibrated as scheduled and
- Support validation activities as needed.Knowledge, Experience &
- Bachelor of Science or college degree.
- A minimum of 2 years' experience in animal research regulations
and especially in GLP.
- Well versed with regulations in U.S. and other regulatory
- Sound reasoning ability to prioritize, act and effectively work
with other departments.
- Able to multi-task and execute with precise attention to
- Good record keeping and attention to detail essential.
- Must be proficient with computers and software such as
Microsoft Word and Excel.
- Excellent communication skills are a must; Good organizational
and problem-solving skills
- Most importantly we seek individuals who exemplify our BTS Team
- Working experience of IQ/OQ/PQ and Software Validations.BTS
- Full time position with a competitive base salary.
- Great benefit package after successful completion of 90-day
- Paid Time-Off
- Above all a positive supportive company environment.
- Must be eligible for work in the United States of America.To
join our team as a contributing member of our research programs
targeted for discovery through IND send your Resume WITH Cover
Letter, Salary History & Requirements, AND three (3) professional
references (in Word or PDF format) to HR@BTSresearch.com Contact Us
Toll Free: (866) 599-3019
Fax: (858) 605-5916
Partnering Strategic collaborations are an important part of BTS
Research growth. Read More > > Need help choosing the right
Contract Research Organization (CRO)? Read More > >
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Keywords: BTS Research, San Diego , Quality Research Associate, Other , San Diego, California
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