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Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendia and non-compendial sources. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with supervision.
Work is closely supervised. Follows specific, detailed instructions.
Contributions are usually limited to task-related activities. Errors do not typically have a major effect on the organization.
Specific QC Focus Areas:
Product Testing: Area focuses on techniques such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays.
Raw Materials: Area focuses on techniques such as wet chemistry compendial testing, Raman, NIR, titration assays, gas testing.
EM/Microbiology: Area focuses on techniques such as bioburden, endotoxin testing, growth promotion studies, environmental monitoring sampling and testing, microbial identifications.
60% of Time: Testing execution
30% of Time: QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
10% of Time: Compliance and quality systems (SOP revisions, input to quality systems records)
Education and Experience Requirements
Normally requires a bachelor’s degree and a minimum of 0-2 years related experience.
(Science related degree is preferred)
Key Skills, Abilities, and Competencies
Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.
Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
Complexity and Problem Solving
Solve routine problems of limited scope and complexity following established policies and procedures.
Works on problems of limited scope.
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Builds stable working relationships internally.
Internal and External Contacts
Contacts are primarily with immediate supervisor, and other personnel in the section or group.
Other Job Requirements
The following physical abilities are required in order to fulfill the job duties:
Repetitive bending and reaching to setup and break-down equipment
Ability to work around chemicals
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
Ability to walk and stand for periods of time
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.
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