Sr. Quality Analyst QA Operations
Los Angeles, California
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
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Sr. Quality Analyst QA OperationsApply Now
This position reports to Weekend Grave (E) shift. This shift schedule is Friday and Saturday 10:00 PM to 10:00 AM, plus Monday and Tuesday 9:0 AM to 5:00 PM. This shift requires working on all company designated holidays. 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 for Pharma and Fractionation/Teardown Quality Assurance 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 Takeda 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 Takeda 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 for the Building 5 and Building 8 area 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 Deviations, 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
- Have strong interpersonal skills
- Have the ability to operate in a dynamic, cross-functional environment
- 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)
- GEMBA - 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 and/or EBM
- 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:
- Typically requires a Bachelor's degree in science, engineering or other related technical field strongly preferred. 2+ years of related 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, as assigned
- Must be able to work overtime as required
- 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.
Job ID SR0049254