This position is responsible for Quality Operations oversight IG Filling operations and performs ongoing daily departmental activities tied to deviation management and lot disposition. Will support Visual Inspection as required. 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. A functional understanding of FDA Aseptic Guidance, EBM, Delta V, FDA, ISO and Quality systems is also required.
- Responsible for reviewing and approving pertinent documents, records and reports such a Manufacturing Batch Records, Forms, etc. against Standard Operating Procedures (SOPs) related to Aseptic Filling Operations for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.
- Perform ongoing daily departmental activities related to deviation management and resolve any issues tied to Product Disposition.
- 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 technical review of Non Conformance investigations including deviations and Out Of Limits (OOLs).
- Responsible for Final Review of Non-Lot Related Events, as needed.
- Performs initial investigative actions on some Events, applying well-established techniques and procedures.
- Responsible for providing Quality Support for Aseptic Simulations (media fills) and validation activities.
- Assist in the management, technical review, and closure of Product Holds (PH) Associated with protocols related to the analyst s area of responsibility.
- 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 multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizen, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- 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.
- Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, and PowerPoint).
- Experience with visual inspection of parenteral drugs
- Ability to prioritize and thrive in a fast-paced environment.
Must be willing to work flex hours and rotations, if necessary
- Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Typically requires bachelor s degree in chemistry, biological science or other related technical field
- Four years plus of relevant pharmaceutical industry experience
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.