What are the responsibilities and job description for the Quality Control Analyst II position at Takeda?
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Job Description:
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Manufacturing U.S.A., Inc. for the following job opportunity
JOB LOCATION : Brooklyn Park, MN
POSITION: Quality Control Analyst II
POSITION DESCRIPTION: Takeda Manufacturing U.S.A., Inc. is seeking a Quality Control Analyst II with the following duties Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers; conduct critical biological test methods (Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, aseptic technique) including samples generated for in-process, drug substance and stability; use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS); initiate and own deviations, CAPAs and change controls within the electronic Quality Management System; exercise judgment within generally defined Quality Control procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions; provide training to new QC Analysts on routine procedures and practices; complete all testing, including special project/protocol testing; maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations; draft studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors; author new SOPs and initiates changes to existing procedures.
REQUIREMENTS : Bachelor’s degree in Biology, Environmental Science, Biochemistry or related field or foreign academic equivalent plus 5 years of related experience. Required skills Perform microbiological and/or physical tests on raw material, in-process products and finished products; initiate low severity level deviations and laboratory investigations within the electronic Quality Management System; conduct critical biological test methods (Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, aseptic technique) including samples generated for in-process, drug substance; use a variety of laboratory instrumentation and computer systems to collect and record data.
Full time. $67,900 - $116,400 per year. Competitive compensation and benefits.
The salary range reflects an anticipated range for this position. The actual base salary 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 and/or long-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.
Qualified applicants can apply at https //jobs.takeda.com. Please reference job # R0145637. EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.
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 :
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:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations:
Brooklyn Park, MN
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
Job Exempt:
No
Job Description:
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Manufacturing U.S.A., Inc. for the following job opportunity
JOB LOCATION : Brooklyn Park, MN
POSITION: Quality Control Analyst II
POSITION DESCRIPTION: Takeda Manufacturing U.S.A., Inc. is seeking a Quality Control Analyst II with the following duties Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers; conduct critical biological test methods (Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, aseptic technique) including samples generated for in-process, drug substance and stability; use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS); initiate and own deviations, CAPAs and change controls within the electronic Quality Management System; exercise judgment within generally defined Quality Control procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions; provide training to new QC Analysts on routine procedures and practices; complete all testing, including special project/protocol testing; maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations; draft studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors; author new SOPs and initiates changes to existing procedures.
REQUIREMENTS : Bachelor’s degree in Biology, Environmental Science, Biochemistry or related field or foreign academic equivalent plus 5 years of related experience. Required skills Perform microbiological and/or physical tests on raw material, in-process products and finished products; initiate low severity level deviations and laboratory investigations within the electronic Quality Management System; conduct critical biological test methods (Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, aseptic technique) including samples generated for in-process, drug substance; use a variety of laboratory instrumentation and computer systems to collect and record data.
Full time. $67,900 - $116,400 per year. Competitive compensation and benefits.
The salary range reflects an anticipated range for this position. The actual base salary 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 and/or long-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.
Qualified applicants can apply at https //jobs.takeda.com. Please reference job # R0145637. EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.
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 :
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:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations:
Brooklyn Park, MN
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
Job Exempt:
No
Salary : $67,900 - $116,400