Sr. Quality Control Tech

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Job Description
About the role:
Conducts and performs many biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations.
How you will contribute
Responsibilities
Identified responsibilities include:

• Collect samples from manufacturing areas to evaluate environmental classification or critical utility integrity.
• Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at the company manufacturing facilities.
• Use laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project/protocol testing.
• Initiate and obtain applicable approval for test requests.
• May maintain inventory/supplies necessary to conduct routine testing.
• Follow continuous improvement practices (QLP, 5S, LEAN)
• Perform equipment maintenance and calibrations.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.

What you bring to Takeda:
Education and Experience Requirements

• Typically requires bachelor's degree in chemistry, biological science, or other related technical field. Some related work experience.

Key Skills, Abilities, and Competencies

• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills and basic knowledge of statistical method.
• Technical problem-solving skills
• Must demonstrate effectiveness in ability to train others
• Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.
• Must be proficient in many mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Will read and follow detailed written instructions.
• Knowledge of basic chemical and biological safety procedures.

Complexity and Problem Solving

• Able to identify when proper practices/ procedures are not performed.
• Follow SOPs and generate results.

Internal and External Contacts
Position acts as a support function to manufacturing operations and is required to coordinate testing activities and communication of results with IG, Fractionation, and Albumin. Also, you will also correspond with other support responsibilities such as QA, Engineering, Maintenance. You may participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.
Other Job Requirements

• May lift, push, pull and carry up to approximately 25 lbs.
• May work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• In general, you will have a combination of sedentary work, standing work, and walking around observing conditions in the facility.
• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
• May work or be assigned to a different shift to meet needs. Must be willing to work off shifts hours.
• Will work supplemental hours to complete work commitments.
• May be required to work in a confined area.
• Inside working conditions.
• Some clean room and cool/hot storage conditions.

You may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and Laboratory Operations with general job requirements summarized below:
AQC:

• Wet/dry chemistry or biochemistry test methods, compendial raw material testing, maintenance of associated assay equipment, and reconciliation of test results.

Microbiology:

• Environment monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.

Compliance:

• Manage and investigation of nonconformance events (OOL, OOS). Develop the site Contamination Control Master Plan (CCMP).

QCMIS:

• Development, validation, and optimization of departmental assays.

Laboratory Operations:

• Support laboratory operations through sample control, equipment metrology, data reconciliation/ archiving, or computerized system programming and support.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional development opportunities
• Tuition reimbursement

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. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and 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,.
• 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.
This posting excludes Colorado applicants.
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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
USA - GA - Social Circle - Hwy 278
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time