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Quality Control Analyst II

2 months ago

Brooklyn Park, United States Takeda Full time

Description

Job Title : Quality Control Analyst II

Location : Brooklyn Park, MN

About the role:

Independently build and review routine in-process, drug substance, and stability test methods promptly. 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). Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. Own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).

How you will contribute:

Demonstrate a functional and basic theoretical understanding of laboratory operations 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. Independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions. Decisions have moderate impact on future QC processes and procedures that impact batch disposition. Initiate and own laboratory investigations, basic complexity low and medium risk deviations, CAPA's, and change controls of moderate scope within the electronic Quality Management System. Participate in cross-functional teams. Draft studies and investigations of moderate scope and work on problems where the situation or data requires a review of identifiable factors. Author new SOP's and initiate changes to existing procedures. Train new QC Analysts on routine procedures and practices. May be required to work overtime or be assigned to a different shift. Perform equipment maintenance and calibrations.

What you bring to Takeda:

Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework 3+ years of experience. Previous experience in a regulated environment preferred. Must understand laboratory instrumentation. Knowledge of cGMP manufacturing Knowledge of chemical, biological and/or microbiological safety procedures.

Key Skills, Abilities, and Competencies

Additional skills include, but are not limited to:

QC Analytical Skill Set – HPLC, UPLC, Appearance, Concentration, pH, Capillary Electrophoresis, Osmolality, TOC, strong micropipetting skills QC Bioassay Skill Set – ELISAs, Cell Maintenance, Cell-Based Assays, Gels, icIEF, Aseptic Technique, strong micropipetting skills QC Micro Skill Set – Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufactuirng Cleanrooms, Aseptic Technique, Critical Utility systems

Other Job Requirements

Physical Demands:

Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.

In certain areas of QC, the following may apply:

Carry weight, lifting - Frequently moves laboratory materials and portable instruments weighing up to 30 pounds. Climb - Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples. Dexterity/balance – required to gown for cleanroom work, balance and dexterity are required.

Other / Travel Requirements:

May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection. May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department. Willingness to travel to various meetings or training, this could include overnight trips. Requires 0-5% travel.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Brooklyn Park, MN

U.S. Hourly Wage Range:

$32.64 - $51.30

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

EEO Statement

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time