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Analyst III, QC Support

Company: Emergent BioSolutions
Location: Lansing
Posted on: January 15, 2022

Job Description:

-- - Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY-- - The Stability Analyst III is responsible for administering and ensuring GMP compliance of the Emergent Stability program at Lansing and contract manufacturing sites. The Stability program generates data to establish and support shelf-life for all Emergent products, raw material and reference standard, from product development, clinical trial I to III, commercial stage and end-product life cycle "discontinuation"-- -. Write and execute stability protocol. Evaluate complex analytical data from the stability program and release to provide recommendation to establish expiration date and specification for release and shelf-life of the product, reference standard or raw material. -- - ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. -- - -- - --- --- - -- -Manage Emergent's product stability program at Lansing and contract manufacturing site ensuring each is in alignment with CFR, MHRA, WHO and ICH guidelines, by reviewing industry guidance. The incumbent to the position will be consider the subject matter expert on from of the regulatory agency for stability program and specification. -- - --- --- - -- -Create and execute stability protocols (all Emergent products, raw material and reference standard, from product development, clinical trial I to III, commercial stage and end-product life cycle "discontinuation"-- -) which includes: Write stability protocols Pull and submit samples to the laboratories Ship samples for testing at contract laboratories Oversight of testing to ensure timely completion Perform routine inventory of all stability samples -- - --- --- - -- -Enter stability data and maintain stability data sets -- - --- --- - -- -Evaluate stability data and release data to drive to product or material specification -- - --- --- - -- -Write final reports, interim study updates. Compile data and write Annual Stability reports and other technical reports as necessary.-- - -- - --- --- - -- -Maintain the Stability pull calendar to ensure all pulls are made on time -- - --- --- - -- -Communicate testing timeframe requirements and scheduling to the appropriate laboratories -- - --- --- - -- -Maintain and monitor the performance of stability chambers. -- - --- --- - -- -Write and assist with the compilation of board of health (FDA, EU, Health Canada, etc.) submissions, -- -annual product reports, IND, validation master plan as needed -- - --- --- - -- -Assist with various QC projects as necessary -- - --- --- - -- -Create new SOP's and revise existing SOPs; write deviations, CAPA's, and Change Controls as needed.-- - -- - --- --- - -- -Evaluate and recommend current and new release and stability specification for product, raw material and reference standard -- - --- --- - -- -Escalate to management potential stability adverse trend of the product, raw material and reference standard that can hinder the ability of this material to reach the establish expiration date.-- - -- - The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.-- - -- - MINIMUM EDUCATION, EXPERIENCE, SKILLS -- - --- --- - -- -B.S. Chemistry, Microbiology or other related scientific field -- - --- --- - -- -5-9 relevance years of experience within a cGMP / FDA / MHRA/Pharmaceutical environment. -- - -- - --- --- - -- -At least 2 years of experience working with stability programs. -- - --- --- - -- -Strong written and oral communications skills -- - --- --- - -- -Strong initiative, organization and ability to work independently -- - --- --- - -- -Capable to lead and/or participate with multidisciplinary team within the site or within the organization -- - --- --- - -- -Strong computer skills with MS Word, Excel, and Adobe -- - --- --- - -- -Capable of executing JMP (or statistical software) and LIMS systems -- - --- --- - -- -Capable to interpret statistical data to determine expiration date and release/ stability specification -- - --- --- - -- -Capable to apply ICH guidelines to setting and monitoring product/ raw material/reference standard specification thru its shelf life. -- - Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. -- - Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.-- - Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. -- - Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . -- - Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent BioSolutions, Lansing , Analyst III, QC Support, Professions , Lansing, Michigan

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