Posted to MedZilla on 11/13/2019


Takeda Pharmaceuticals

US-CA, Sr Quality Analyst Critical Systems Facility Engineering SR0042495-MZ


 
 

This position will be part of the QA organization primarily responsible for supporting Critical Systems, Facilities, and Engineering functions at the Los Angeles Facilities. The incumbent will provide quality assurance decisions to daily operations and assure compliance with current GMP, GDDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Takeda Quality practices.

The incumbent will also support facility walkthroughs, continuous improvement initiatives, and compliance projects relating to areas of responsibility. The incumbent will also review and approve Deviations (Level 1) and provide assessments for changes (insignificant and return to operations forms) in accordance with internal procedures and ensure compliance with regulatory requirements. The incumbent will review document changes.

The incumbent will also provide technical knowledge and/or support investigation teams in troubleshooting/problem-solving activities as applicable. Self-led individual that works under only very general supervision to meet deadlines/goals.

Essential Duties and Responsibilities

  • Partner with manufacturing or areas of responsibility to ensure sound quality decisions are made.
  • Provide oversight to ensure a current GMP area is maintained for the Critical Systems, Facilities, and Engineering (FE) area.
  • Performs review and approval of Level 1 Deviations as assigned.
  • Provide guidance on Product Impact Assessments
  • Perform assessments for insignificant change controls and return to operations forms to ensure change packages are accurate and meet proper release requirements set forth.
  • Review and approve SOPs as required. Review or draft memos, reports, protocols, and other appropriate documentation as they pertain to department operations and procedures.
  • Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement.
  • Support ongoing daily department activities across all shifts for Critical Systems and when required assist other Quality areas in the successful performance of these activities.
  • Support process/product improvement projects. These projects may be executed through CAPA, QWT, Kaizen, or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control.
  • Assist in department with audit-ready status efforts and understand FDA, Takeda, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a resource for compliance with these requirements.
  • Drive Lean principles such as 5S throughout daily work activities.
  • Embrace Quality Culture

Qualifications

  • Having strong interpersonal, influencing, and negotiation skills.
  • Have the ability to operate in a dynamic, cross-functional environment.
  • Have good verbal and written communication skills.
  • Have general knowledge of biotech manufacturing theories and processes.
  • Capable of managing multiple tasks and support projects concurrently.
  • Have strong organizational skills and the ability to plan and suggest resolutions to technical problems.
  • Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.
  • Have good critical thinking and problem-solving skills (DMAIC, Six Sigma, and Lean).
  • Working knowledge of regulatory guidance (e.g. CFR and USP).
  • Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office). Capable of performing data analysis through various applications software.
  • Be able to support departmental / plant goals.
  • Be able to provide technical review and approval of investigations.
  • Be able to work independently and with limited supervision.

Education and/or experience

  • Bachelor's degree in science, engineering or other related technical field strongly preferred. 2+ years of related experience.

Physical Demands

  • Must be able to lift, push, pull and carry up to 25 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends.
  • Must be able to work supplemental hours as necessary to complete work commitments.
  • Some travel may be required
  • May be required to work in a confined area.

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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