Senior Scientist Chemistry - Kalamazoo - 49005

ROLE SUMMARY
This posting is for a colleague in the method validation and the early stage testing laboratory which is part of PGS-Kalamazoo Quality Operations (QO). The team supports multiple technology method implementations in Kalamazoo and the transfer of similar types of methods within the site or externally. Projects include plant network method/product transfers, new product/method implementations, Co-development work with external/internal customers including Research & Development, and internal Continuous Improvement method optimization work.
ROLE RESPONSIBILITIES
Optimizes, validates, and supports multiple technology method implementations and the transfer of similar methods within the site or externally. Provides a single point of contact for analytical method transfers/validations to the site (internal and external) for network method/product transfers, new product/method implementations, Co-development work with external/internal customers including Research & Development, and internal Continuous Improvement method optimization work.
Completes analysis of raw materials, in process intermediates, final active pharmaceutical ingredients (APIs) or final drug products independently according to procedures to determine compliance with specifications. Prepares stand-alone submission ready protocols/reports in support of the company's quality control programs and methods.
Accountable for activities involved in bringing new analytical methods into the release labs to support the introduction of new products to the site, with a focus analytical technology capability assessment, AMTE protocol and report authoring, and Test Plan creation. Work collaboratively with other colleagues to identify potential failure modes for methods and other procedures and be able to solve complex analytical problems using various analytical tools. Review and approval of the validation protocols and reports to ensure compliance with company standards and cGMP requirements and other regulatory and/or industry guidelines and practices. Investigate validation problems for equipment and/or performance processes, conducting statistical analyses of results and process anomalies where applicable, and writing, reviewing, approving and/or implementing documentation for new and current validation procedures and technical reports related to methods, equipment, products and/or processes.
The successful candidate will work closely with
* GCMC-Site Compliance teams to prepare documents to support site regulatory submissions
* Work with various project teams to ensure that the correct methods and validation strategies are executed with respect to Process, Equipment, and Cleaning Validation.
BASIC QUALIFICATIONS
* Required: Bachelor's degree in Chemistry and at least 4 years' experience in related field or Master's degree in Analytical Chemistry and at least 2 years' experience.
* Proactive approach and strong critical thinking skills and a good work-ethic
* Excellent written and verbal communication
* Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
* Demonstrated ability to meet timelines with minimal supervision and interact with multi-disciplinary teams.
* Demonstrated ability to manage ambiguity, new technologies, complex analytical problems and to proactively make progress with limited information or direction.
* Attention to detail and demonstrated willingness to learn new things.
PREFERRED QUALIFICATIONS
* Preferred: 4 years' experience in a related area
* Master's degree in Analytical Chemistry

PHYSICAL/MENTAL REQUIREMENTS
Work will primarily be performed in a laboratory and a less frequently in an office environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May from frequently need to support production when required after regular working hours for extended lengths of time. Schedule is on 1st shift, M-F.
Other Job Details
* Last Date to Apply for Job: November 30, 2021
* Eligible for Relocation Package: YES
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Quality Assurance and Control