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 compliance.
- Maintain the BTS SOP and Forms systems, including review, revisions issuance, and intranet uploads.
- Create and modify documents (SOPs, Forms) using Microsoft Office.
- Perform Quality Control on study specimens and samples prior to shipment.
- Assist in investigating and closing CAPAs.
- Ensure non-clinical studies are archived in a timely manner.
- Equipment Management
- Maintains BTS Asset Inventory List.
- Assigns asset numbers to all incoming equipment.
- Ensures that the asset numbers have equipment files and calibration logs.
- Ensures that equipment is calibrated as scheduled and needed.
- Support validation activities as needed.
Knowledge, Experience & Education
- 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 requirements.
- Sound reasoning ability to prioritize, act and effectively work with other departments.
- Able to multi-task and execute with precise attention to detail.
- 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 values:
- Honest Communication
- Working experience of IQ/OQ/PQ and Software Validations.
- Full time position with a competitive base salary.
- Great benefit package after successful completion of 90-day probationary period.
- Health & Dental
- 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