3 Data Auditor AR&D Jobs in Winchester, KY
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Data Auditor AR&D
$70k-93k (estimate)
Full Time | IT Outsourcing & Consulting
1 Week Ago
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AMPCUS is Hiring a Data Auditor AR&D Near Winchester, KY
Job Description :
This position supports laboratory data auditing that includes reviewing the technical documents like protocols/reports/test methods, specifications, and the SOPs etc. related to AR&D with minimum supervision from the supervisor. Employees at this level can manage their time effectively while executing a broad range of high visibility tasks to provide scheduling and alignment for the AR&D Department in support of internal and external customers. This position requires strong knowledge of technical and analytical requirements of AR&D laboratory.
Analytical R&D Auditors are responsible for performing technical review of raw material/in process/finished good data for release and stability along with other protocol-based studies that are executed in AR&D for regulatory submissions. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as per business needs.
II. Specific Tasks & Duties
* Read and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal Client methods, customer/supplier methods and other technical documents.
* Perform technical review and approval of all data including notebooks/certificate of analysis, stability summaries etc. for compliance with approved test methods, specification, and applicable internal SOPs for routine release testing of raw materials, in-process samples, finished products and stability samples for development batches, GMP/clinical batches and registration activities
required for the regulatory submissions.
* Perform technical review and approval of data, protocols and reports related to method qualifications (transfers/verifications/validations) including other protocol-based studies (photostability, comparative dissolution studies, dose dump studies etc.) performed in AR&D required for regulatory submissions.
* Author / review SOP's that fall within defined area of subject matter expertise. Review other technical documents not limited to specification, test methods, Certificate of analysis/Report of analysis, protocols/reports, and other technical documents as needed.
* Participate in customer/internal/regulatory agency audits as necessary.
* Assist in training analytical scientists.
* Perform analytical testing as per business needs.
* Assist in laboratory investigations.
* Draft or review CAPAs and audit responses as needed.
III. Essential Skills and Experience:
Education or Equivalent:
* Ph.D., M.S, or B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry).
o Work Experience - 3 years of pharmaceutical industry experience with a Ph.D. degree, and with at least 2 years of analytical testing/research experience using HPLC/GC/UV, etc.
o Work Experience - 4 years of pharmaceutical industry experience with a M.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.
o Work Experience - 5 years of pharmaceutical industry experience with a B.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.
Knowledge/Skills Requirements:
* Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, g/mL, etc.), molarity, Beer's Law, reference standard purity on as is, anhydrous, or dry basis etc.
* Ability to multi-task with high efficiency.
* Ability to coordinate and prioritize to support manufacturing and quality agreements.
* Ability to work well under pressure and maintain efficiency both on an individual and team basis.
* Ability to communicate effectively.
* Strong knowledge in Empower software.
* Advanced knowledge and demonstrated performance in regard to all lab safety process and procedures and the ability to work safely with chemicals of varying potency.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
This position supports laboratory data auditing that includes reviewing the technical documents like protocols/reports/test methods, specifications, and the SOPs etc. related to AR&D with minimum supervision from the supervisor. Employees at this level can manage their time effectively while executing a broad range of high visibility tasks to provide scheduling and alignment for the AR&D Department in support of internal and external customers. This position requires strong knowledge of technical and analytical requirements of AR&D laboratory.
Analytical R&D Auditors are responsible for performing technical review of raw material/in process/finished good data for release and stability along with other protocol-based studies that are executed in AR&D for regulatory submissions. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as per business needs.
II. Specific Tasks & Duties
* Read and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal Client methods, customer/supplier methods and other technical documents.
* Perform technical review and approval of all data including notebooks/certificate of analysis, stability summaries etc. for compliance with approved test methods, specification, and applicable internal SOPs for routine release testing of raw materials, in-process samples, finished products and stability samples for development batches, GMP/clinical batches and registration activities
required for the regulatory submissions.
* Perform technical review and approval of data, protocols and reports related to method qualifications (transfers/verifications/validations) including other protocol-based studies (photostability, comparative dissolution studies, dose dump studies etc.) performed in AR&D required for regulatory submissions.
* Author / review SOP's that fall within defined area of subject matter expertise. Review other technical documents not limited to specification, test methods, Certificate of analysis/Report of analysis, protocols/reports, and other technical documents as needed.
* Participate in customer/internal/regulatory agency audits as necessary.
* Assist in training analytical scientists.
* Perform analytical testing as per business needs.
* Assist in laboratory investigations.
* Draft or review CAPAs and audit responses as needed.
III. Essential Skills and Experience:
Education or Equivalent:
* Ph.D., M.S, or B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry).
o Work Experience - 3 years of pharmaceutical industry experience with a Ph.D. degree, and with at least 2 years of analytical testing/research experience using HPLC/GC/UV, etc.
o Work Experience - 4 years of pharmaceutical industry experience with a M.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.
o Work Experience - 5 years of pharmaceutical industry experience with a B.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.
Knowledge/Skills Requirements:
* Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, g/mL, etc.), molarity, Beer's Law, reference standard purity on as is, anhydrous, or dry basis etc.
* Ability to multi-task with high efficiency.
* Ability to coordinate and prioritize to support manufacturing and quality agreements.
* Ability to work well under pressure and maintain efficiency both on an individual and team basis.
* Ability to communicate effectively.
* Strong knowledge in Empower software.
* Advanced knowledge and demonstrated performance in regard to all lab safety process and procedures and the ability to work safely with chemicals of varying potency.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Job Summary
JOB TYPE
Full Time
INDUSTRY
IT Outsourcing & Consulting
SALARY
$70k-93k (estimate)
POST DATE
05/03/2024
EXPIRATION DATE
05/16/2024
WEBSITE
ampcus.com
HEADQUARTERS
CHANTILLY, VA
SIZE
50 - 100
FOUNDED
2010
TYPE
Private
CEO
KAZHUMKIL SALIL SHANKARAN
REVENUE
$50M - $200M
INDUSTRY
IT Outsourcing & Consulting
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About AMPCUS
Ampcus provides cloud computing, cybersecurity, digital transformation and web development services for businesses.
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