Posted to MedZilla on 9/22/2019


Takeda Pharmaceuticals

US-GA, Supervisor, Quality Assurance SR0039388-MZ


 
 

This position is responsible for Quality oversight of Packaging and Visual Inspection Operations supporting 3 production lines and visual inspection operations, supporting daily operational meetings and production activities. Incumbent will be required to partner with multiple manufacturing, Engineering, maintenance, and Manufacturing Sciences managers for rapid problem solving and influence decisions.

  • 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 resolve 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 Corrective action plans.
  • Responsible for technical review and approval of Non Conformance investigations including deviations and Out of Limits (OOLs) and Change Control records.
  • Responsible for supporting Customer Complaint investigations with inspection of retention samples and returned product.
  • Process the closure of Non-Lot Related Events, extension requests and commitment records in the Trackwise database.
  • Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely manner.
  • Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Shire quality requirements.
  • Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical, and supervisory skills.
  • Manage direct on the floor support of packaging and visual inspection operations, labels and printed material management, retentions sample and reject management.
  • Must be able to support manufacturing operations in lieu of absent personnel by maintaining all required qualifications.

Must be willing to work Swing Shift as well as some weekends and Holidays to support manufacturing operations.

Qualifications:

  • 20/20 eye sight, no color blindness, attention to detail, and must be able to perform visual inspection of large parenteral vials.
  • Strong interpersonal skills and great attention to detail are necessary. Must be able to influence decisions based on regulatory knowledge, and must have excellent problem solving, as well as verbal and written communication skills.
  • Must have the ability to manage people, encourage teamwork and drive actions based on strategy. The position will include the supervision of assigned personnel on multiple shifts in achieving defined quality goals in an efficient, accurate and timely manner.
  • Must have ability to evaluate, train, and develop direct reports.
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V, MES Systems)
  • Must have knowledge of FDA Regulations, Applications of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Must demonstrate excellent critical thinking skills and understanding of complex manufacturing processes and make risk based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.

Preferred experience: Visual inspection of parenteral drugs and packaging operations; electronic batch management systems.

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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