Analytical Method Validation (AMV) Scientist
Company: Torrent Pharma Inc.
Location: Levittown
Posted on: February 22, 2021
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Job Description:
**This role requires candidates to be located in or around
Levittown, PA**Torrent Pharma Inc. is a multi-billion dollar
company leading the way across the globe within the Biotech and
Pharmaceutical industry. With a significant presence in over 40
countries, Torrent Pharma Inc. is looking to continue expanding its
US base further. Torrent is seeking a qualified AMV Scientist to
join our Quality Team in Levittown, PA.Essential Duties and
Responsibilities:* Daily set-up, operation, troubleshooting and
maintenance of instrumentation such as HPLC, UPLC, UV, GC, KF,
FTIR, and IC in accordance with written SOPs* Provides technical
project leadership, participating in protocol development and
execution for test method validation / verification and related
activities* Provide expert level troubleshooting of laboratory
equipment methods and process* Maintain lab work area and
documentation in a neat and orderly fashion* Maintain data within a
laboratory notebook in a legible, organized, and compliant manner,
and transcribes or enters data into necessary records in an
accurate and timely manner* Reviews generated data in a timely
manner and elevates any Non-Conformance, Out of Specification, or
other Deviation to Laboratory Management promptly for further
investigation.* Performs investigative testing or other functions
to assist with laboratory investigations.* Assists in execution of
training and acts as a mentor to less-experienced analysts.* Works
in support of production and development projects and may require
weekend, off-shift work, or overtime as necessary to complete high
priority work assignments* Interacts regularly with other
departments including R&D, RA, and QA to ensure priorities are
aligned and products are on track.* Reviews procedures and
completes required documentation or updates as appropriate as part
of Periodic review process* Performs laboratory testing of Raw
materials, In-process, Finished product, and Stability samples for
potency and physical characteristics in accordance with company
SOP's as well as cGMP's* Manages projects to improve Laboratory
compliance and efficiency.* Works on development products, methods
and projects to support R&D initiatives* Works with computers
as well as laboratory software, or proprietary software as
neededADDITIONAL RESPONSIBILITIES:* May require technical review of
previously generated data for Regulatory responses.*
Responsibilities for the appropriate documentation and disposal of
unused laboratory samples and expired reagents.* Maintain and
demonstrate a high level of personal and professional integrity and
Report any suspicious activity to laboratory management.* Assists
Laboratory Management on special projects and assignments*
Additional responsibilities may be assigned by Laboratory
Management as neededQUALIFICATIONS:To perform this job
successfully, an individual must be able to perform each essential
Duty satisfactorily. The requirements listed are representative of
the knowledge, skill, and / or ability required. Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions.Competencies/Skills: *
Proficiency in Microsoft Office particularly in Excel, PowerPoint
and Word.* Proficient in technical writing* Strong organizational
skills and the ability to multitask* Demonstrated ability in
working independently and as part of a team* Must be able to work
in a cross-functional environment interacting with other internal
departments and external vendors* Excellent communication (oral and
written) and interpersonal skills* Must be able to communicate
technical, scientific, and regulatory information, both written and
verbally* Proficient knowledge USP and ICH guidelines of method
validation and verification* Ability to work in a detail-oriented
manner* Ability to meet attendance standards. All full-time
employees are required to work a 40-hour week. At times it may be
necessary to work additional hours in order to accomplish the
required tasks to meet deadlines.* Must have a teamwork attitude*
ability to apply common sense understanding to carry out multi-step
instructions* deal with standardized situations with occasional
variables* ability to interpret data utilizing intermediate math
operations; perform complicated analytical calculations and
statistical analysis* ability to read and comprehend instructions
in the English language through verbal and written methods.*
ability to write or speak in the English language and communicate
information effectively in one-on-one and in a group of employees
within the organization.Education and/or Experience: * B.S. or
higher in Science Field, Chemistry Degree Preferred.* 10 or more
years of demonstrated excellence in the field of analytical
chemistry.* 5 or more years of experience in method validation/
verification* Demonstrated technical expertise in instrumental
laboratory analysis.* Prior experience in a pharmaceutical (cGMAP)
laboratories setting is required* Prior Project management
experience preferred
Keywords: Torrent Pharma Inc., Levittown , Analytical Method Validation (AMV) Scientist, Other , Levittown, Pennsylvania
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