Synerfac -
Newark DE
QA Lab Auditor
Posted May 16
Apply Now
May 16
Apply Now
Job description
QA Lab Auditor - Newark, DE
$40,000-$50,000
Summary:
Will be responsible to audit and report each assignment to management to ensure their client services conform to applicable Good Laboratory Practices and Guidance Documents (FDA, OECD Principles, Japanese MHLW). Incumbent will perform duties with integrity and ensure all records and business affairs assigned to them are kept in a confidential manner (i.e., controlled, protected, and secured).
Essential Functions:
* Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOP(s), procedures and actual data results obtained during the study.
* Compare analytical procedures to the protocol and validated methods to ensure proper study conduct.
* Identify noncompliance and deviations, and recommend corrective and preventative actions in an educational and persuasive manner.
* Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director and Management and verify their follow-up responses are adequate and complete to close the audit.
* Assist with client and government audits or any department goals as requested by supervisor or manager
Education / Experience:
* Bachelor"s degree in Biology, Biochemistry, Immunology, Analytical Chemistry or other related scientific discipline preferred
Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Computers run on a Windows based operating system and proficiency with MS Office products, including Outlook, Word, Excel and PowerPoint, is required.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This role is primarily sedentary, but the employee is occasionally required to traverse to other floors, offices, or sites to interact with colleagues or visitors, as well as to bend, stoop or reach to access filing and storage cabinets. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
***If interested and meet the requirements, please send your most up to date resume to:
...@synerfac.com
Job Requirements
Knowledge / Skills / Abilities:
-Ability to understand and comply with GLP regulations, principles and Guidance Documents.
-Ability to identify resources and use them to formulate solutions, make decisions and implement them.
-Ability to identify noncompliance and deviations and recommend corrective and preventative actions in an educational and persuasive manner.
-Ability to anticipate and identify critical issues or problems and recommend solutions.
-Ability to deal with conflict and drive resolution independently or through proper chain-of-command.
-Considers implications when making system-based recommendations and decisions.
-Demonstrates Life Sciences technical skills and the abilities necessary to achieve goals.
-Effective verbal and written communication skills.
-Proven ability to exercise good judgment and effectively balance work activities and changing priorities.
Why you should apply:
* Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
* Structured Career Ladders that provide excellent growth based on your personal aspirations.
* Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
* Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
* Park-like setting in Newark, Delaware
* Internal committees designed with the needs and enjoyment of QPS employees in mind....
$40,000-$50,000
Summary:
Will be responsible to audit and report each assignment to management to ensure their client services conform to applicable Good Laboratory Practices and Guidance Documents (FDA, OECD Principles, Japanese MHLW). Incumbent will perform duties with integrity and ensure all records and business affairs assigned to them are kept in a confidential manner (i.e., controlled, protected, and secured).
Essential Functions:
* Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOP(s), procedures and actual data results obtained during the study.
* Compare analytical procedures to the protocol and validated methods to ensure proper study conduct.
* Identify noncompliance and deviations, and recommend corrective and preventative actions in an educational and persuasive manner.
* Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director and Management and verify their follow-up responses are adequate and complete to close the audit.
* Assist with client and government audits or any department goals as requested by supervisor or manager
Education / Experience:
* Bachelor"s degree in Biology, Biochemistry, Immunology, Analytical Chemistry or other related scientific discipline preferred
Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Computers run on a Windows based operating system and proficiency with MS Office products, including Outlook, Word, Excel and PowerPoint, is required.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This role is primarily sedentary, but the employee is occasionally required to traverse to other floors, offices, or sites to interact with colleagues or visitors, as well as to bend, stoop or reach to access filing and storage cabinets. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
***If interested and meet the requirements, please send your most up to date resume to:
...@synerfac.com
Job Requirements
Knowledge / Skills / Abilities:
-Ability to understand and comply with GLP regulations, principles and Guidance Documents.
-Ability to identify resources and use them to formulate solutions, make decisions and implement them.
-Ability to identify noncompliance and deviations and recommend corrective and preventative actions in an educational and persuasive manner.
-Ability to anticipate and identify critical issues or problems and recommend solutions.
-Ability to deal with conflict and drive resolution independently or through proper chain-of-command.
-Considers implications when making system-based recommendations and decisions.
-Demonstrates Life Sciences technical skills and the abilities necessary to achieve goals.
-Effective verbal and written communication skills.
-Proven ability to exercise good judgment and effectively balance work activities and changing priorities.
Why you should apply:
* Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
* Structured Career Ladders that provide excellent growth based on your personal aspirations.
* Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
* Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
* Park-like setting in Newark, Delaware
* Internal committees designed with the needs and enjoyment of QPS employees in mind....
