Supply Chain Investigations Specialist
North Reading, Massachusetts
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
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Supply Chain Investigations SpecialistApply Now
The responsibilities for the Supply Chain Investigation Specialist will be to lead investigations to analyze data and information to determine scope, impact, root cause and corrective / preventation action for Materials Management (MM) owned minor operations deviations and non-conforming materials. They will manage the closure within established timelines work with QA and management to escalate quality systems when necessary.
- Organizational control of Quality systems:
- Own and close Non-Conforming Materials deviations and minor operations deviations
- Support cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations to management on batch disposition
- Collaborate with Quality Control, Quality Assurance and Warehousing to disposition or reject material based on quality systems conclusions.
- Resolve conflicts that arise, escalate as needed.
- Work cross-functionally and represent Supply Chain on MA Bio Ops projects to include process improvements, tech transfers, new materials and equipment, and investigations
- Provide assistance in responding to observations from internal audits and external regulatory inspections to include implementing corrective actions and process improvements
- Identify ways to improve compliance within the MM department. Work with the Compliance Manager and other members of the leadership team to make positive change. Participate in regulatory and internal audits which may include direct interaction with inspectors for CAPA and/or development of responses.
Education and Experience Requirements:
- Bachelor’s in Science or a related discipline
- Minimum of 2 years related industry experience in the manufacturing and/or development of biologics, pharmaceuticals or devices preferred
- Previous experience owning manufacturing deviations/investigations preferred
- Previous experience creating and revising SOPs preferred
- Experience with managing multiple commodity areas and tasks effectively in a fast-paced work environment
- ERP experience in Inventory Warehouse Management / Materials Management / Procurement modules
- Ability to manage work and influence decisions in a high matrix organizational environment
- Demonstrated ability to manage collaboration and influence cross-functionally for process improvement initiatives
- Experience working in a high growth environment with changing priorities is essential
- Experience in manufacturing procedures, shop/work orders, working in a GMP regulated environment preferred
- Experience in the Biotechnology, Pharmaceutical fields preferred
Key Skills, Abilities, and Competencies:
- Strong written and verbal communication skills
- Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
- Work is performed with minimal direction/supervision.
- Ability to lead and influence investigation team members to coordinate work based on priorities
- Must be proficient with record management systems such as TrackWise (or equivalent)
- Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
- Experience with more advanced Microsoft applications including Visio, Project, and SharePoint a plus
Complexity and Problem Solving:
- Ability to identify priorities manage numerous projects simultaneously
- Lead problem resolution meetings/teams effectively
- Ability to shift priorities to meet required deadlines
- Effectively identify risks and communicate issues cross-functionally in a timely manner
- Thorough understanding of biopharmaceutical manufacturing
- Comprehensive understanding of industry regulations and cGMP compliance
- Ability to apply industry regulations to decision making process
- Strong presentation skills
- Strong problem-solving skills and attention to detail
Internal and External Contacts:
- Facilitates, consults and collaborates with cross-functional teams including but not limited to Manufacturing, Facilities and Engineering, Manufacturing Sciences & Technology, Quality Control, Validation, Operational Excellence, and Health, Safety & Environment, and Quality Assurance.
Other Job Requirements:
- May include travel between MA Bio Ops sites
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Job ID SR0044474