- and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal methods, customer/supplier methods and other technical documents.
- 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.
- 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.
- / review SOPs 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.
- in customer/internal/regulatory agency audits as necessary.
- in training analytical scientists.
- analytical testing as per business needs.
- in laboratory investigations.
- or review CAPAs and audit responses as needed.
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Research And Development Specialist - Winchester, United States - Acro
Description
ONSITE
ASSIGNMENT DURATION - 6 + MONTHS
SHIFT - MON-FRI 8AM - 5PM.
JOB DESCRIPTION
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.
Specific Tasks & Duties
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, Beers 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.
