Analyst II, QC
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
Perform analytical testing per cGMP in support of raw material, in-process, final product, stability. T
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc.
• Perform analytical work per method transfer/ validation programs.
• Work with Project Managers and QA to ensure timely testing and release of samples.
• Perform instrumental analysis such as Karl Fischer, UV, HPLC and Gas chromatography.
• Inform supervisor upon observing out of specification results.
• Perform moderately complex test methods such as ELISA, etc.
• Participate in investigations of OOS results and other related studies.
• Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Write protocols and reports as necessary.
• Write and review SOP’s and Testing Standards as necessary.
• Assist in training other Analysts.
• Review, analyze, interpret and report data.
• Verifies and enters approved results in LIMS.
• Complies trend analysis and write associated reports for internal and regulatory use.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Track time worked per project.
• Participate in meetings as required.
• Participation in biomedical screening is required
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education: A minimum of a B.S. in Chemistry or related field.
Experience: Minimum of 1 years of experience in a chemistry laboratory or equivalent with a Master’s Degree or Ph.D., or 3 years with B.S degree. GLP/GMP experience is preferred. Empower, LIMS and/or SAP experience is preferred.
Knowledge: College and industry-level knowledge of general chemistry or biochemistry principles, math and writing skills are minimum requirements. Must be knowledgeable of common laboratory applications such as wet chemistry, titration, chromatography and UV. Must be able to proficiently apply knowledge to new and existing testing applications.
Skills: Can perform at an intermediate level of Excel and Word. Must possess knowledge of table building in Excel and formatting in Word. Must be able to write legibly and accurately and contemporaneously record work in written and electronic form.
Abilities: Effective verbal and written communication, the ability to complete daily tasks as assigned, the ability to improve processes, the ability to work independently and in a group, the ability to multi-task, and the ability to train on and learn computer-based programs and systems. Proven demonstration of qualifications related to Excel, Word, LIMS, or SAP systems is preferred, including course work.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.
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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.