As a Microbiology Scientist, you will be responsible for analyzing drug product, drug substance and environmental monitoring microbiological contamination to support our quality programs. Your contribution to environmental testing, bioburden testing, endotoxin testing, microbial identifications, and sterility testing.
* Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
* Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
* Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
* Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
* Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.
* Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
* Train junior colleagues and develop training plans and oversee training activities for groups.
* Responsible for contributing to and/or handle laboratory investigations for events and Out of Specification results.
* Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
* Perform laboratory support functions and maintain work area in a neat and orderly manner.
* Write Standard Operating Procedures, technical reports, project plans and other documents independently.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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https://insightglobal.com/workforce-privacy-policy/ .
* 3+ years of experience for more senior, 3+ for junior level
* Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.
* Experience with purity testing, viability, suitability of growth, streaking and isolating colonies, media making, Bioburden, water testing (do not have to have all of these -- but at least several)
* Understanding of aseptic laboratory techniques and quality systems
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.