STUDY DIRECTOR - HIGHPOWER Validation Testing & Lab Services, Inc., a Henrietta NY based medical device testing laboratory is looking for a full time Study Director to help support the unique needs of a small growing laboratory. Candidate should be professional, hard-working, and knowledgeable in either ISO 17025, 13485, 9001 or FDA/GMP Quality systems. The ideal candidate should have scientific background with attention to detail and excellent written/verbal communication.
Study Directors are assigned validation studies from project initiation to completion. Study Directors perform many tasks, including (but not limited to) the following;
- Work directly with clients to gather information and write test protocols
- Generate custom raw data sheets to support complex test plans
- Perform technical reviews on raw data and final reports
- Answer client questions and lead weekly client progress meetings
- Provide frequent updates to clients on study progress, and communicate testing failures
- Perform initial investigation into failed testing prior to notifying clients
- Provide follow-up support to clients after issuance of final reports
- Request specific test materials and supplies to complete client testing
- May coordinate with subcontracting laboratories
- May validate new processes, procedures or equipment in the laboratory
- May write IQ/OQ/PQ validations
- Any other duties as needed to meet the needs of HIGHPOWER and our clients
Study Directors should be familiar with the standard concepts, practices, and procedures performed within the medical device validation and testing field. They rely on an understanding of industry standards and methodology to plan and help execute client objectives. Study Directors must be independent and able to work on multiple projects simultaneously.
Must have proficient skills in writing procedures, test protocols, final reports and have excellent organizational skills. Study Directors report to Executive Mgmt and Client Services. Study Directors will perform any other duties as requested by Management.
Experience with the following is helpful but is not required;
- Protocol development of laboratory experiments
- FDA GMP/GLP and the FDA’s Quality Systems Regulation part 820
- ISO 17025 Quality System
- Sterilizers and mechanical washers
- General lab functions and inventory of test labs.
- Complaints, CAPA’s, compliance and O.O.S. investigations
Working hours are 7:30 am to 4:00 pm Monday thru Friday. This position is primarily administrative, must be able to sit and utilize computer/keyboard for the length of a normal workday.
Employee benefits include:
Competitive salary with medical & dental insurance, 401(k), Christmas bonus, vacation & sick/personal leave, along with various voluntary insurances including Dental, Short Term Disability etc.
Minimum Qualifications:
Bachelor’s degree in appropriate science or a minimum of 5 years equivalent work related experience within a lab setting. Excellent written and oral communication skills, proficiency in Microsoft Office.
Salary:
Based on experience
Job Type: Full-time
Pay: $67,500.00 - $70,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
Ability to Relocate:
- Rochester, NY 14623: Relocate before starting work (Required)
Work Location: In person
