Associate Scientist / Scientist, QC Analytical
Posted on: February 21, 2021
PerrigoPerrigo Company is dedicated to making lives better by
bringing high quality and affordable self-care products that
consumers trust everywhere they are sold. Help us do it.Associate
Scientist / Scientist determination is based upon level of
experience and education.The person in this role provides technical
support to assigned projects, using robust scientific methods which
comply with standard operating procedures and scientific standards.
Works with limited direction and as appropriate, may serve as a
project leader to manage analytical support for projects with
supervision.Key Responsibilities include:
- Perform physical and chemical testing on raw material,
in-process, finished product and stability samples. This includes
documentation and review.
- Develop, validate and transfer non-complex to complex
- Research, prepare and review technical documents, including but
not limited to SOPs, drug master files, technical packages, vendor
qualification, raw material and release and stability
specifications, stability summaries, test methods, and certificates
of analysis which conform to company standards.
- Successfully investigate and resolve analytical problems,
project issues and deviations. Accurately maintain all related
documentation in compliance with SOPs.
- Prepare documents for regulatory filings (ANDA, NDA, ANDS).
Design experiments and provide data to support responses for FDA
minor deficiency letters.
- Attend and present data at project-related meetings, interact
with other departments and outside testing laboratories to ensure
proper analytical testing.
- Training of other scientistsRequirements:Bachelors of Science
degree; Typically a minimum of 2-4 years work experience
required.Helpful Experience and Skills
- Hands on experience and troubleshooting skills on
chromatographic separation (GC, GC-MS, HPLC, UPLC and LC-MS),
particle size distribution (laser diffraction and mechanical
sieving), light microscopy, spectrophotometric (FTIR, UV-VIS),
atomic absorption spectroscopy, ICP-OES, ICP-MS, dissolution
techniques, moisture analysis by Karl Fischer.
- Solid experience on various additional characterization methods
such as viscosity/rheology, texture analyzer, thermal analysis (DSC
- Knowledge of the United States Pharmacopeia, European
Pharmacopeia, applicable FDA Guidance & ICH Guidelines
- Proficiency on method development of assay, impurities,
dissolution, water content, and physical characterization methods
for different dosage forms#DIVEqual Employment
Keywords: Perrigo, Kalamazoo , Associate Scientist / Scientist, QC Analytical, Other , Allegan, Michigan
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