https://amzn.to/44P6GXZ
The Role
In this role, you will support QC Labs with review of test records and manage QC Quality records (e.g. Change Controls, deviations, CAPA, Lab investigations, etc.) as well as author/update cGMP documents.
Here’s What You’ll Do
Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
Work with QC group to maintain and update all necessary training documentation including; On-The-Job Trainings, Training Materials, Instructor Led Training, and Knowledge Checks.
Supports authoring and revision of laboratory procedures and reports
Support authoring quality systems records such as deviations, change controls, CAPAs as required
Supports team to Investigate and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
Lead projects as assigned
Additional duties may be assigned
Here’s What You’ll Need (Minimum Qualifications)
BA or BS degree in Biology, Microbiology or similar field
5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
Previous experience managing quality records such as change controls, deviations, and lab investigations
Here’s What You’ll Bring to the Table (Preferred Qualifications)
In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
Experience with rapid microbiological methods
Expertise in aseptic technique training and concepts
Experience with performing laboratory and deviation investigations
Experience in Technical writing and SOPs
Proficiency with Microsoft Office Programs
Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
Excellent communication skills (verbal and written)
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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