Posted to MedZilla on 8/23/2019


Takeda Pharmaceuticals

US-MA, Quality Control Investigation Specialist III SR0035360-MZ


 
 

Primary Duties

Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not be limited to investigation activity, data analysis, data trending, cross functional team support, document revisions, initiating/completing quality systems, identifying CAPA for system improvements, change control ownership, and other activities.

Discretion/Latitude:

  • Work is closely supervised. Follows specific, detailed instructions.

Impact:

  • Contributions are usually limited to task-related activities. Errors do not typically have a major effect on the organization.

Specific QC Focus Areas:

  • Area is focused on environmental monitoring data analysis and reporting, microbiology data trending, microbiology laboratory investigations and CAPAs, LIMS interface, MODA interface, Trackwise interface, and other support systems related to microbiology laboratory.

Technical Support:

  • Area is focused on various technical investigational and compliance tools in support of the GMP laboratories, EM trending and reporting, EM excursion execution, laboratory deviations, cross functional team membership, and CAPAs related to EM excursions and laboratory deviations.

Responsibilities

Job Function and Description

  • 60%: Data analysis, data trending, data reporting, EM excursion analysis and completion, deviation management
  • 20%: Regulatory and/or inspection support, initiating/completing quality systems, such as change control or CAPA
  • 20%: Involvement in other QC activities as required (ex. records retention)

Education and Experience Requirements

  • Normally requires a bachelor s degree and a minimum of 6-8 years related experience.
  • Science related degree is preferred

Additional Specific Experience:

  • Excellent communication, interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Ability to prioritize work and multitask.
  • Conducts work in compliance with cGMPs, safety and regulatory requirements.

Key Skills, Abilities, and Competencies

Knowledge:

  • Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.

Key Skills:

  • MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding

Complexity and Problem Solving

  • Solve routine problems of limited scope and complexity following established policies and procedures.
  • Works on problems of limited scope.
  • Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.

Internal and External Contacts

  • Contacts are primarily with immediate supervisor, and other personnel in the section or group. Contacts in other departments, such as manufacturing and facilities, will also be frequent.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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

Reasonable Accommodations

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.


Please visit our website at takedajobs.com

 
 


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