This position is responsible for Quality Assurance Release activities and performs ongoing daily departmental activities tied to Fulfillment of Finished Product.Must be able to handle and manage multiple projects. Demonstrate effectiveness in task completion, decision-making, exception management, training, problem solving and team leadership. Support or Assist PMT, QWT, Kaizen or equivalent focus type group activities as needed
Essential Duties and Responsibilities:
- Responsible for reviewing and approving pertinent documents, records and reports such a Manufacturing Batch Records (MBRs), Forms, etc. against Standard Operating Procedures (SOPs), which comprises the majority of the work performed.
- Perform ongoing daily departmental activities related to Product Releases and resolve any issues tied to Product Release as assigned.Perform the review, approval, and authentication of Product Release Documentation as assigned.
- Responsible for initiating, tracking, investigating and completing documentation associated with exceptions and corrective actions resulting from process, equipment and facility deviations for the areas as needed.
- Serve as a team member and/or assist in CAPA Investigations for significant issues.
- Responsible for Final Review of Events, as needed.
- Assist in the management, technical review, and closure of Product Holds (PH) Associated with protocols related to the analyst s area of responsibility.
- Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely
- 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.
- Support in the development of customer awareness and understanding activities for areas of direct responsibility and, where appropriate, assist and support such activities throughout the facility.
- Support with Internal and External Quality audits/assessments and provide ongoing feedback related to quality issues.
- Support and drive continuous improvements consistent with the divisional strategy and ensure compliance to all applicable state, federal and international regulations.
- Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
- Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment.
- Represent department in cross-function projectsSkilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
- Ability to prioritize and thrive in a fast-paced environment.
- May perform other duties as assigned.
- Have the ability to operate in a dynamic, cross-functional environment.
- Have strong interpersonal skills
- Be able to be flexible.
- Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions.
- Be able to have great attention to detail is necessary.
- Be able to handle multiple tasks and projects concurrently
- Have strong organizational skills and the ability to plan, follow-up, and implement tasks.
- Have good critical thinking and problem solving skills (DMAIC, Six Sigma, and Lean).
- - good investigational experience who goes to the floor see the actual process where event occurred and who also implement robust Corrective Actions for the correct Root Causes.
- Yellow Belt/Green Belt training/certification preferred.
- Have good verbal and written communication skills.
- Have general knowledge of biotech manufacturing theories and processes.
- Have knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP).
- Be able to perform and analyze trending through the use of DeltaV system.
- Be able to generate spreadsheets and power point presentations on the computer.
- Be able to support departmental / plant goals.
- Be able to review and approve investigations
- Be able to work independently and with intermittent supervision
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
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.