Position Title: Associate Expert Microbiology Work Location: East Hanover, NJ 07936 Assignment Duration: 12 Months Work Schedule: Work in shifts covering daytime hours from 12 PM to 8 PM and work one or both weekend days at least once per month. Shifts will be fixed based on business needs. Work Arrangement: Onsite Position Summary: Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department. Key Responsibilities: • Perform micro/EM testing in support of clinical release strategies. • Perform all testing and activities compliantly following appropriate SOPs and procedures. • Maintain controls and reference standards to support testing. • Executes and follows SOPs, WPs, and quality policies. • Peer review and archive analytical data in lab documentation systems. • Support monthly/quarterly laboratory cleaning. • Appropriate use of laboratory logbooks and monthly laboratory cleaning. • Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities. • Ensures cleanliness of laboratory working areas. • Support and author OOS/OOE/OOT and deviation investigations. • Participate in CAPA implementation in a timely manner. • Follows GxP quality policies and procedures. • Ensures all assigned training is completed within required time frame. • Support 5S and Lean projects. • Identify process improvements. • Knowledge of LabWare, LIMS and/or other QC data systems. • Knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.). • Support execution method qualification/optimization of methods. • Interface with regulatory agencies during audits as required. • In addition to these primary duties, provide coverage for all appropriate areas. • Contributes to assigned projects by following predefined tasks and executing as instructed. • Perform other job duties as assigned. • Collects and generates data for trend reporting. • Verify the accuracy of data generated. • Contributes to the gowning qualification program by taking samples and analyzes and generates data. Qualification & Experience: • BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science or equivalent work experience. • Fluent in English. • 1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry. • Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.). • Thorough knowledge of microbiological and environmental monitoring, test methods. • Microbiology/Environmental Monitoring knowledge to facilitate investigations. • Knowledge of LIMS systems. • Ability to communicate clearly with a variety of individuals in various aspects of our organization operations. • Detail-oriented with expertise in problem solving and solid decision-making abilities. • Strong interpersonal skills which include a professional demeanor when interacting with our organization personnel. • Strong written and verbal communication skills are essential. Connecting media strategy with loyalty strategy Conduct business strategy reviews to assess progress of strategy achievement Spanning growth strategy and continuous development Developing business and operational strategy around technology Leverage strategy and analytics partners Ensure ongoing alignment with strategy Develop the content strategy including website content Providing content, strategy and design recommendations Providing analytical and strategic support to the pricing strategy lead Provide analytical support to the strategy development process Develop new and ongoing efforts for business strategy Spearheading and leading innovative sourcing strategy projects Identifying the correct strategy for tool Guiding the development and launch of digital marketing strategy across channels Conduct projects to drive Level 3's market evolution, product strategy, and/or overall business strategy Translate market opportunities into concrete product strategy and tactical roadmaps Develop a proactive workforce strategy and plan Reviewing the process and strategy of investment portfolio implementation Organize strategy material and transaction documentation Implement strategy for innovative solutions and superior servicesaa415a4b-8b21-40fc-a65c-70d2b25ca29a
