Quality Control Analytical Scientist II

Actual Job Title: Quality Control Analytical Scientist II
100% ONSITE

Summary
As a QC Analytical Scientist II, you will support various Quality Control activities within the
AQC department. Key responsibilities are to transfer and execute analytical methods,
including raw materials, for use in a CGMP environment in Quality control, both analytical
quality control methods (AQC) and Quality Control Microbiology methods (QCM).

Essential Duties and
Responsibilities

Drive special projects that require AQC attention/leadership.
Drive analytical method development and validation of laboratory methodologies and
instrumentation. This includes leading analytical/microbiology QC efforts to support the
introduction of new product testing, modifying existing laboratory space, plan design
new laboratory spaces and working with vendors to purchase new instruments, and the
installation and qualification of new instruments.
Support investigations and manufacturing investigations requiring analytical method
support.
Support the installation, operational qualification (IOQ), maintenance and
troubleshooting of instrumentation in the AQC group.
Serve on project teams, in a leadership role as needed, which will require substantial
interaction and communication with other group functions.
Upgrading of analytical technologies within an established licensed technology platform.
Support the execution and issue resolution (e.g., discrepancies) and completion approval
of test plans/protocols
Support troubleshooting of analytical methods and instruments and support laboratory
investigations as needed to provide scientific justification for initial Out of Specification
(iOOS), Out of Trend (OOT), and atypical result investigations
Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews,
and other documentation that requires advanced analytical knowledge.
Ensure all laboratory equipment is maintained in a validated state and that all analytical
methods transferred follow company and regulatory requirements.
Responsible for protocol and report generation as well as authoring CMC submission and
other technical documents as required. This includes supporting raw material
qualification for new products
Manage and perform assay control and critical reagent qualifications, including
monitoring and trending of method performance.
Support the analysis of QC data using statistical tools to identify trends and set limits for
results, including data transcription/entry
Use sound scientific principles and statistical techniques to solve problems and make
recommendations.
Responsible for deliverables to ensure timelines and milestones are met.
Support scheduling of AQC and QCM testing (release, execution of protocols, etc.).
Lead small teams as needed to accomplish tasks.
Representative for Analytical projects with global and local site functions. Ensure Right
First Time (RFT) in the method introduction and instrument qualification process
Other duties as assigned.

Qualifications
Excellent technical writing skills and able to write technical documents and reports that
meet company and regulatory requirements
In depth knowledge of analytical methods and operations with strong emphasis in
problem-solving.
Knowledge about analytical method validation and critical reagent qualification.
Intermediate statistical knowledge and experience with data analysis.
Knowledge concerning cGMP, especially lab related topics such as method validation and2
unexpected results investigation.
Basic knowledge about regulatory requirements concerning analytical instrumentation,
test methods and licenses.
Substantial knowledge and understanding in terms of regulatory standards requirements
e.g., CGMP, QSR, USP, 21CFR, ICH etc.
Ability to complete tasks with minimal direction, demonstration of basic project
management skills.
Ability to multi task in a highly dynamic and diverse environment.
Attention to detail, good organization, and time management skills to meet deadlines.
Proficient in Microsoft Office.
Strategic and business-oriented thinking.

Education and/or
experience

Bachelor s degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
Minimum of 3 years of analytical development or validation experience in GMP
Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an
advanced degree.

Physical Demand The overall physical exertion of this position requires light to medium work.
Working
Environment

Normal office and laboratory environment.
May need to work in controlled or clean room environments requiring special gowning.
May work around chemicals such as alcohol, acids, and buffers that may require
respiratory protection.
Able to work more than 8 hours a day or 40 hours a work week as needed.