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Job Description

About the Role:

The position is responsible for Quality oversight of both the Packaging and Visual Inspection Operations, supporting daily operational meetings and production activities. Incumbent will be required to partner with Manufacturing, Engineering, Maintenance, and Manufacturing Sciences teams.  

How you will Contribute:

• The position is responsible for Quality oversight of both the Packaging and Visual Inspection Operations, supporting daily operational meetings and production activities. Incumbent will be required to partner with Manufacturing, Engineering, Maintenance, and Manufacturing Sciences teams.

• Will write, review, analyze and revise written Standard Operating Procedures (SOPs) and support development and review of Protocols, Qualification, Regulatory Submissions, etc.

• Perform ongoing daily departmental activities related to deviation management and aid any issues tied to product disposition, including timely batch record reviews to ensure on time release of batches.

• Develop plans to correct identified risks including areas of non-conformance and approve and device strategy to implement effective CAPA’s.

• Responsible for technical review and approval of Non –Conformance investigations including deviations and Change Control records.

• Responsible for supporting Customer Complaint investigations with inspection of retention samples and returned product.

• Process the closure of Non- Product lot related investigations, extension requests and commitment records in the Trackwise database.

• Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Quality requirements.

• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical, and supervisory skills.

• Must be able to support manufacturing operations in lieu of absent personnel by maintaining all required qualifications.

• Leads ongoing, daily departmental operations. 

• May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner

• Evaluate, train and develop VI & Packaging QA team.

• Provide quality oversight for packaging operations, including control of printed materials, visual inspections, verification of labels and product packaging, perform AQL inspections, Batch Record review- meeting requirements of CFR 21.

• Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on packaging compliance

• Other duties, tasks, or projects as assigned

What you bring to Takeda:

• Associates degree in business/scientific discipline and one to three years of relevant experience preferred.

• Bachelor’s degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred

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:

• 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/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 pha