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Shire Senior Quality Assurance Specialist (Plasma: Fractionation and Purification / Aseptic Filling) in Round Lake, Illinois
SUMMARY: The SENIOR MICROBIOLOGY / STERILITY ASSURANCE SPECIALIST functions as the primary QA Microbiology / Sterility Assurance delegate at Takeda's Round Lake, IL manufacturing site with a focus on establishing and maintaining a comprehensive contamination control program (Environmental Monitoring (EM), Bioburden and Mold Reduction, etc.). They are responsible for the overall logistics and oversight of the EM and microbiological testing services provided by third-party Microbiology lab; drives the completion of gap assessments against EM and Contamination Control global procedures, identifies appropriate mitigation actions, and owns/manages the Contamination Control Program (CCP) for the site; owns deviations/CAPAs associated with contamination events (e.g., EM and solution bioburden adverse trends); owns and contributes to significant projects such as Final Product (FP) sterility sample size reduction, increased sterile filtration time, etc.; handles multiple departmental projects while demonstrating effectiveness in task completion, decision-making, training, problem solving, and leading without authority; leads CAPA, Kaizen, or equivalent focus-type group activities as required; implements Regulatory Authority’s requirements regarding microbiological relevant topics (EM, product bioburden, media fill, hygiene topics, aseptic behavior, etc.) and compliance with regulations and global procedures; Quality observation of media fills and sterilization qualifications; conducts GEMBA walks to ensure contamination control in the manufacturing areas, and performs investigational sampling of environmental air and surfaces within manufacturing areas.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Manages overall logistics and oversight of third-party Microbiology Lab, including scheduling, investigation support, etc. Drives completion of gap assessments to global standards and procedures; identifies appropriate mitigation actions, and owns / manages CCP for the site Owns deviations / CAPAs associated with contamination events (e.g., EM and solution bioburden adverse trends), leads investigations and authors investigation reports Authors and leads the execution of validation studies for microbiology-related processes in alignment with Global Microbiology, e.g., disinfectant validations, equipment cleaning validations, etc. Owns and contributes to significant projects such as FP sterility sample size reduction, increased sterile filtration time, etc. Provides timely reporting of third-party Microbiology Lab KPIs; trends and analyzes microbiological testing and EM data for Management Review Serves as SME for Microbiology/Sterility Assurance; leads audit readiness efforts in understanding FDA, Takeda, and other regulatory and quality requirements; maintains a high level of expertise in current regulatory requirements and serves as a laboratory resource for compliance to these requirements Serves as operational liaison with various internal customers (e.g., Manufacturing, Global QC, Global Microbiology, Technical Services, etc.) Brings local SOPs into compliance with Global Standards / Requirements Participates in Network Strategy / Takeda Community of Practice meetings to stay informed of global changes Provides expert statements and risk assessments regarding sterility and other microbiological aspects for lot release (deviations and change control) Responsible for topics regarding Media Fills, EM, Product Bioburden and Endotoxin testing, Gowning, Aseptic Processing, and Contamination Control Provides site-based training for hygiene, aseptic behavior, gowning requirements, product and rinse water sampling Uses LIMS to collect, trend and analyze EM and FP microbiological test data for Product Quality Review and present at Management Reviews Performs laboratory and manufacturing audits as required Represents the Laboratory through technical presentations, CAPA review board, Management Reviews, and other department presentations Embodies the Takeda Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an Excellent Manager of Self and Others.
QUALIFICATIONS: Demonstrated ability to apply advanced scientific principles, theories, concepts, practices and standards to process and product development; keeps current with scientific knowledge in areas of expertise (ex. FDA regulations, GLP, GDP and GMP); provides input to the development of new scientific knowledge Demonstrated ability to manage multiple tasks and projects concurrently and drive projects to completion in a timely manner Must have experience with and knowledge of bacterial colony characteristics and morphologies Strong understanding of facility critical systems and laboratory and manufacturing processes Strong competence with Microsoft Word, Excel, PowerPoint; capable of performing advanced data analysis through various application software programs Must have strong interpersonal communication skills, influencing/negotiation skills, strong verbal and written communication skills and ability to work effectively and efficiently in a team environment Strong presentation skills Demonstrated skill in leading without authority General knowledge of statistical techniques; working knowledge of CFR and USP Data Integrity guidelines a plus Knowledge in applying technical problem-solving tools; Lean Instructor or CAPA investigator certification a plus; Black Belt or Six Sigma training / certification a plus In-depth knowledge of change control practices for major manufacturing equipment and critical systems In-depth knowledge of quality systems including exception management, change control, document control, etc. Demonstrated effectiveness in training others, driving results, and meeting deadlines
EDUCATION AND/OR EXPERIENCE: Requires a Bachelor's Degree in Microbiology or Biological Sciences with 5+ years of related experience in the pharmaceutical industry; or Master’s Degree in Microbiology or Biological Sciences with 2-4 years of experience Experience must be in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment
PHYSICAL DEMANDS: In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility (light to medium work) May be required to gown frequently and balance when gowning into clean areas Will be required to work around moving equipment and machinery May be exposed to noise above 85 dBA; this may require hearing protection and other protective equipment to be worn May be required to work at heights above floor level May be required to work with biohazards such as bloodborne pathogens, or medical waste in production and lab areas
WORKING ENVIRONMENT: 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 or jewelry may be worn within the controlled manufacturing environments Will work in clean room, cool/hot storage conditions, cold/wet environment, and confined areas for investigational purposes Must be willing and able to travel up to 10% of the time and to work outside of regular business hours, including weekends
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.
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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 is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.