Posted to MedZilla on 3/25/2019


Takeda Pharmaceuticals

US-GA, Quality Assurance Specialist II/IG and Albumin Release SR0031492-MZ


 
 

  • Leads ongoing, daily departmental operations.
  • This position focuses on the QA release process of IG final container and Albumin CPA release process.
  • May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner. Interview/hire, evaluate, train and develop direct reports.
  • Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Able to navigate, answer alerts and review Batch Records in EBM.

Provide necessary floor support to the manufacturing teams and help in resolving

  • Support external assessments or audits.
  • 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 relevant area(s).
  • Other duties, tasks or projects as assigned.

This position will require at times to work swing shifts depending on IG and Albumin release needs.

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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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.