What are the responsibilities and job description for the Sterility Assurance Specialist position at Takeda Pharmaceutical?
This position will facilitate and manage the oversight of routine and investigational samples, own and provide support for CAPA investigations, review, approve and maintain trending of third-party laboratory results, and support the facility’s Contamination Control Program.
Responsibilities:
- Provides timely reporting of third-party Microbiology Lab KPIs; trends and analyzes microbiological testing and EM data to support Management Review.
- Own and support investigations related to environmental and utility monitoring out of limits deviations.
- Provide support to external departments for completion of investigations.
- Acquire and maintain cleanroom and gowning qualification for cleanroom manufacturing areas.
- Provide support to the facility’s Contamination Control Program and continuous improvement initiatives.
- Basic understanding of microbiological techniques and concepts. • Conduct investigational sampling in support of investigations.
- Support logistics and oversight of routine and investigational samples with our third-party Microbiology and Chemistry laboratories.
Qualifications / Experience:
- Strong background in Microbiology.
- Strong analytical and problem solving skills.
- Excellent verbal and written communication skills in English
- Must be able to deal with ambiguity and make decisions under stressful conditions
- Should be current in knowledge of state-of-the art processes and systems related to production as well as contamination control and aseptic practices in cleanrooms.
- Must be able to work in controlled/classified environments requiring special gowning. Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. • Deals with plasma-derived finished products; transfer of intermediates and products between sites/countries.
- A degree in Microbiology or other science with a minimum of 1 to 3 years of experience in Quality, Aseptic Manufacturing (preferably with strong focus on fill/finish operations) or related field in the pharmaceutical industry. Non-degree with adequate work experience will be considered. • Work as a team member in meeting departmental goals and objectives
Cannot be allergic to Cephalosporin drugs to apply for this position.
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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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Reasonable Accommodations
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.