This position reports to Swing (2nd) shift. This shift schedule is Monday to Friday on a modified shift, tentatively for 10:00 AM to 6:30 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Successfully perform all primary activities which include providing daily quality assurance to operations, review and release of batch records and associated documents within the manufacturing facility, provide support on change control processes, and participate and support internal and external audits.
Assure compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Shire Quality practices.
Review and release batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.
Provide assessments to support day to day change control processes (insignificant changes and return to operations) in accordance with internal procedures and ensure compliance with the FDA and ISO requirements.
Good understanding and knowledge of current regulatory requirements i.e., FDA, ISO, and Shire Quality Systems, and serve as a plant resource for compliance to these requirements.
Essential Duties and Responsibilities:
Partner with shift manufacturing to ensure sound quality decisions are made
Provide oversight to ensure a GMP area is maintained on shift
Obtain resolution on areas identified as non-conformance Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements
Performs initial investigations and reviews Events, CAPAs, and User Interventions
Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement
Review and release batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc
Work with change owners to ensure change packages are accurate and meet requirements set forth
Develop, lead and execute project(s) as assigned by management
Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed
Assist in external and internal audits by collecting and reviewing documents as assigned by management
Provide guidance and training of employees within the department
Provide guidance to members of other departments with regards to critical step verification
Support activities for another section or department as assigned by management
Support initiatives and project linked to key plant metrics or quality goals
Work with change and/or protocol owners to ensure change and/or protocol packages are accurate and meet requirements set forth
Have strong interpersonal skills
Have the ability to operate in a dynamic, cross-functional environment
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)
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 PowerPoint 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
Education and/or experience:
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
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 overtime as required (APPLICABLE TO Non-Exempt only).
May be required to work in a confined area
Some clean room and cool/hot storage conditions
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.
Takeda Pharmaceutical Company Ltd