US-MA, Quality Control Senior Analyst SR0032419-MZ
Job Summary/Operations Involvement:
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/product and various protocol studies using test methods derived from the various compendia and non-compendial sources. The position is expected to maintain operational and GMP readiness of the QC area. In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects. Position is expected to act as a role model for junior staff in the various QC areas.
Work is performed under general direction with little to no supervision. Participates in determining objectives of assignments. Plan schedules and arranges own activities in accomplishing objectives. Work may be reviewed upon completion for adequacy in meeting objectives.
Exerts some influence on the overall objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Specific Biochemistry Focus Areas:
Role is responsible for biochemistry laboratories performing a broad range of techniques such as enzyme assays, PCR, SDS-PAGE, and compendial tests in order to support in-process, release and stability testing.
Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
60-40% QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)30-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support30-10% Testing execution, participate in training analysts, trouble shooting of methods
Education and Experience Requirements
Typically requires a bachelor s degree and a minimum of 5+ years of related experience. (science related degree is preferred)
Additional Specific Experience:
Excellent communication, interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Previous experience in a GMP QC role is preferred
Other Job Requirements
Limited to no travel expected. Travel between sites is required.
The following physical abilities are required in order to fulfill the job duties:
-Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
-Ability to work around chemicals (if working around the laboratories)
-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
-Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
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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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