Analyst III, QC Raw Materials

Emergent BioSolutions • Canton, MI

22h • Onsite

About The Position

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. 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. Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department. 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. Leads change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable. Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable. Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly). Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC. Perform entering sample and result of raw materials into Lims Lab Vantage system. Communicate and coordinate with third parties and/or other departments. 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. Perform daily activities in routine sampling raw materials, 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. Lead Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies. 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.

Requirements

• 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. (Mainly QC Raw Material background)
• 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.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• 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.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• Comprehensive knowledge of regulatory/industry guidance.

Nice To Haves

• Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.

Responsibilities

• 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.
• Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department.
• Supports the implementation of the raw material program at EMOB.
• Leads change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
• Perform entering sample and result of raw materials into Lims Lab Vantage system.
• Communicate and coordinate with third parties and/or other departments.
• 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.
• 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.
• Lead Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.

Benefits

• Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
• Comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level