Quality Control Analyst I

Takeda•Brooklyn Park, MN

3d•Onsite

About The Position

As a Quality Control Analyst I, you will execute routine in-process, drug substance, and stability test methods. Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).

Requirements

Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework.
0-3 years of relevant experience.
Must be able to communicate effectively with managers and peers.
Must be able to read, write, and converse in English.
Must have basic computer skills.
General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service.
Good interpersonal skills and able to work effectively and efficiently in a team environment.
QC Analytical Skill Set – HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micropipetting skills
QC Bioassay Skill Set – ELISA’s, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinets

Nice To Haves

Previous experience in a regulated environment preferred.
Laboratory instrumentation understanding or experience preferred.
Knowledge of cGMP manufacturing preferred.
Knowledge of basic chemical, biological and/or microbiological safety procedures preferred.
Must display eagerness to learn and continuously improve.

Responsibilities

Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP’s).
Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required.
Complete all testing, including special project and protocol testing in a timely and appropriate manner.
Maintain data integrity and ensure compliance with company SOP’s, specifications, and cGMP regulations.
Support low risk deviations, CAPA’s and change controls within the electronic Quality Management System.
Initiate and own laboratory investigations.
Occasionally participate in department problem-solving.
Author minor revisions to existing SOP’s.
Receives general instructions on routine work and detailed instructions on new assignments.
May be required to work overtime or be assigned to a different shift as needed.
May perform equipment maintenance and calibrations as required.
Complete mandatory training within required timeframe.
Employee at this level is involved in routine tasks of basic scope and complexity.
Employee receives detailed instructions on new work and refers to policies and procedures for guidance.
Responsible for conducting independent work with guidance from trainers and more senior staff.
Responsible for making basic decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis.
Understand the needs of key collaborators (i.e., Quality and Manufacturing Operations) to provide compliant and timely test results.
Perform other duties as assigned.