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Study Director
HIGHPOWER Validation Testing & Lab Services —Rochester, NY
- $67,500 - $70,000 a year
- Full-time
- Background check
- 5 years
- Writing skills
- Health savings account
- Disability insurance
Quick Apply
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DATA ENTRY
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Administrative Assistant
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Data Entry Operator II
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Study Director

HIGHPOWER Validation Testing & Lab Services
Rochester, NY

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Job Details

Full-time
$67,500 - $70,000 a year

Benefits

Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Paid time off

Qualifications

Laboratory testing protocol documentation
Medical writing
Experimental data reports
Writing skills
Microsoft Office
Laboratory reports
Bachelor's degree
Scientific protocols
Organizational skills
Productivity software
Customer complaint resolution
Scientific reports

Full Job Description

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

Quick Apply

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