Specialist I, QC Analytical
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
Provides oversight of quality control assay/instrument/laboratory related software development, qualification, and validation activities. Provides oversight, consultation, and training for EMOB Quality Control (QC) to ensure compliance with GMP and health regulatory agency guidelines in relation to laboratory operations, instrumentation, and validation activities.
Provide oversight to support product release & stability or nonclinical/ clinical studies (GMP or GLP compliant) or product discovery, proof of concept studies, and candidate selection, and characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Responsible for participating in the design, execution and review of analytical assay/equipment development, transfer and qualification/ validation, and comparability studies to meet regulatory and ICH guidelines.
• Collaboration with other departments for assay/instrument/laboratory related software development, qualification, and validation activities.
• Process lead for Change Control, CAPAs, Laboratory investigations, and other quality management system documents.
• Lead investigator for critical/major deviations and OOS/OOT reports for assays and laboratory equipment/instruments.
• Responsible for generation of quarterly/annual trending reports reporting the status of QC quality systems. Trend OOS, OOT, and Laboratory Events to identify equipment process improvements; collaborate with QC Compliance to ensure GMP/GLP/GDP throughout all QC assay/equipment processes.
• Responsible for participating in Data Integrity Assessments/ risk assessments for equipment/instruments.
• Maintain QC labs, documents and data in an inspection ready manner and be able to respond to audit observations. Participate in documentation revisions and review
• Manage and present QC KPIs and metrics; utilize these to identify possible process improvements.
• Provide technical support, apply expertise, and critical thinking to help resolve technical and compliance issues.
• Assist in responses to any internal audit, corporate audit, or regulatory audit observations involving Quality Control.
• Oversight of laboratory operations and help maintain equipment compliance, adhere to PM and calibration schedules.
• Collaborate with validation to review and execute validation studies, reports, comparability studies, etc
• Ensure that lab activities and instrument operations are conducted according to safety guidelines, policies, and legislation.
• Provide technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments
• Contribute to departmental strategy and provide input on lab requirements and improvements.
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
• Bachelor’s degree in chemistry, biology, pharmaceutical sciences, or related field of study.
• Minimum of 8-10 years directly related experience in the pharmaceutical/biopharmaceutical or related industry.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• Proficient and professional communicator, verbally and in writing.
• Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
• Strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Proficient in complex procedures and problem solving.
• Strong commitment to teamwork, proven leadership skills, independence and initiative.
• 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.
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.