Analyst III, QC (Raw Materials)

Location
Baltimore (Bayview), MD, US
Posted
Feb 06, 2021
Ref
711642800
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

I: JOB SUMMARY

Perform methods and procedures for inspecting, testing, and evaluating raw materials. Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other Emergent sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend and implement corrective actions.

II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Supports the implementation of the raw material program at EMOB
• Prepares specifications, SOPs, and method verification protocols and reports
• Ships samples and monitors test results produced by contract testing laboratories
• Communicates with raw material manufacturers to implement testing methodologies at EMOB
• Schedule daily activities in routine testing of raw materials and cleaning samples
• Performs required data analysis, compiles data, and prepares results for review
• Conducts wet chemistry, chromatographic, and spectroscopic testing
• Performs other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified
• Supports raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor's Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience
• Experience with spectroscopic methods, chromatography, and wet chemistry methods
• Familiarity with global pharmacopeias and monograph testing
• Ability to follow SOPs and comply with cGMPs; generate SOPs
• Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics
• Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography
• Experience working in a pharmaceutical testing environment
• Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff

IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.

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