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Senior Quality Control Investigator at Shire Human Genetic Therapies, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Lexington, Massachusetts





Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Senior Quality Control Investigator

Location: Lexington, MA (USA)

About the role:

As the Senior Quality Control Investigator, you are responsible for oversight and execution of complex and critical deviations and investigations related to quality control (QC) out of specification (OOS), out of trend (OOT), and/or process failures within the quality control labs.

How you will contribute:


  • Responsible for completion of root cause analysis (RCA) and identification and generation of corrective and preventative actions stemming from investigation.

  • Organize, oversee, and perform investigation write-ups within allotted time frames.

  • Partner with manufacturing, quality assurance, and other applicable departments to ensure that RCA is complete, and investigation is completed.

  • Pursue continuous improvement opportunities related to contamination control

  • Will be the subject matter expert in microbiological matters

  • Will make decisions with the best path forward in assignment of CAPA investigation records

70% Quality Control Investigations and CAPAs

10% Continuous Improvement in QC

10% Metrics/Performance KPIs

10% Inspection and regulatory support

What You Bring to Takeda:


  • Bachelor's degree in technical or scientific discipline.

  • Typically requires 7+ years of related experience.

  • Prior experience investigating quality control deviations within the pharmaceutical biologics space.

  • Prior experience investigating and troubleshooting issues related to microbial control (including environmental monitoring).

  • Familiarity with common analytical instrumentation/software

  • Experience in environmental monitoring and microbial control.

  • Experience with regulatory audits Blue/Green Belt certification preferred but not required

  • QC Microbiology and analytical assays is preferred but not required

  • Technical writing skills.

  • Experience investigating quality control deviations and running and troubleshooting microbiology assays.

  • Can solve complex problems in high-level investigation

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 training 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, 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 to 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

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 - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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