Senior Specialist, Quality
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Senior Specialist, Quality Systems & Compliance will work, independently and in a Team setting, in the BTS (Bio-Analytical Technical Support) 3R (Reduce, Refine and Replace) Team. Work will include direct involvement in the development, trouble shooting and validation of new in vitro assays to replace animal model-based (in-vivo) assays. This role is recognized as a technical expert, readily conducts complex experimentation, and comprehends the under-lying scientific principles behind applicable scientific methods and projects. For this position a strict focus will be on delivering value for customers by comprehending and meeting their needs and will also require active listening skills to gain differing perspectives and strategic thinking and project management skills.
Development, troubleshooting and validation of novel in vitro assay
Routine partnership with BTS 3R Team Leads, Regulatory Affairs (RA), Quality Control (QC), Bio-Analytical Technical Support (B-ATS), Research & Development (R&D), Bioprocess Tech Support Production, colleagues as appropriate
Periodically reviews and preparation of in vitro test data for statistical analysis
Chairs or participates in cross-functional project teams (including R&D, Regulatory Affairs, Quality, Ops, statisticians, etc.)
Manages reference standards and supporting bio-material inventories used in assay development
Supports local, regional, and global program initiatives
Conducts subject related literature searches
Initiates, conducts, and reports experiments using new ideas and/or approaches described in the literature
Interacts closely with fellow scientists within their own and other departments. If required, initiates contacts with external collaboration partners in consultation with the direct manager
Involved in authoring and review of development and validation reports
Prepares training plans and supervises training of new employees
Fulfills general tasks within the organization related to GMP, Environmental, Health & safety (EHS), and Information and Technology (IT)
Publishes and presents technical papers to internal and external audiences, (co-) author of scientific publications
At least a Bachelor's degree in science, engineering, or related areas of study.
At least 5 years of relevant work experience in the pharmaceutical/biotech industry
Good Manufacturing Practices (GMP) | Good Laboratory Practices (GLP) settings
Prior bench level laboratory experience
Expanded knowledge in at least one biological area; experience in other biological areas
Strong computer skills (Excel, PowerPoint, Word etc.) with effective communication and writing skills
Development of bioassays
Biological assays (ELISA, Luminex, HPLC, Virus Titration, Bacterial Plate Count, PCR, and Toxin-Neutralization Testing)
Managing critical reagent inventories
Preparing and interpreting basis statistical reports
Preparing reports for regulatory authorities
Capable of adapting to change and quickly learning new skills and concepts
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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