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The Opportunity Join a company that finds solutions to complex challenges. With expertise in influenza science and beyond, our team works on the latest research and pioneering technologies to improve the manufacturing process and the effectiveness of influenza vaccines. We operate as one integrated global organization drawing together expert staff from different countries to collaborate. Together, we are working to protect communities from seasonal influenza and global pandemic threats. When you join CSL Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose to deliver our promise. Job Summary Reporting to the Manager, Customer Account Management, you will maintain a group of accounts within multiple customer segments, e.g. Retail, Wholesale/Distribution, IDN, and Independent/Corporate owned HealthCare Professionals. You will complete the order to cash management of vaccine orders and develop long-lasting client and sales relationships. You will work directly with our Sales, Demand Planning, Distribution & Logistics, Marketing, Market Access, and Finance teams to prioritize important accounts and guide strategic goals. You will monitor vaccine distribution, financial health, and delivery performance against a contract and manage the customer experience. You will apply independent decision-making to exceed business standards. Job Responsibilities Account Management • Manage a portfolio of important accounts, maximizing opportunities to make improvements, • Analyze accounts for contract adherence while ensuring services are aligned with the goals of the account, • Partner with customer service teams to resolve account issues, • Work with the finance department to ensure customer's financial health is in good standing Data Analysis and Reporting • Run data quality queries which include billing, shipping, order creation, contract, and pricing, to identify data exceptions to plan and implement strategic plans, • Support sales with custom reporting and data insights, • Creation and distribution of applicable customer account reporting on a routine basis Strategy and Improvement • Provide detail level recommendations to help Sales with working on customer strategy, • Identify gaps in processes and recommend opportunities for improvements, • Analyze complex problems, interpret operational needs, and develop integrated creative solutions, • Monitor and evaluate programmatic and operations effectiveness and implement improvements Training and Leadership • Lead by example to train sales and analyst teams, • Help with peer-to-peer learning, • Help write test cases, scripts, and testing of new system enhancements Customer Experience • Represent the CSL Seqirus Customer Experience vision internally and externally while being the voice of the customer with your team to address customer challenges, • Follow established procedures while understanding internal and external drivers necessary to operational success Collaboration and Communication • Coordinate with team members including, Sales, Executive Leadership & Demand Planning, • Use multiple communication channels to seek and offer feedback, • Strengthen relationships and networks by asking open questions and sharing information, • Self-govern while receiving coaching to achieve operational targets, • Maintain awareness of relevant internal/external trends and consider implication of work Minimum Experience Requirements • Bachelor's Degree or equivalent combination of education and experience, • Minimum 3 years of experience in a regulated industry, experience with vaccines or biologics products is desirable, • Account management skills to support demand planning, data control, and serving as contact for account-related activities, • Experience ensuring agreement between contracts and orders to resolve discrepancies and variances, • Experience working with a variety of teams (Finance, Sales and Distribution, QA, IT, Customer Experience, eCommerce, and Leaders at different levels), • Proficiency in MS excel (can perform complex functions) and SAP (6.0 later preferred), EDI ordering, reporting, and SAP sale-order management experience is an advantage Culture and Values • Demonstrate CSL Seqirus Values: Patient Focus, Innovation, Integrity, Collaboration, and Superior Performance, • Unleash outcomes while creating an accountable work environment, • Self-leaders that are flexible, resilient, and able to adapt effectively through change The expected base salary range for this position at hiring is $80,000 – $95,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation. CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals. Please take the time to review our ___ to see what’s available to you as a CSL Seqirus employee. ___ is part of ___. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more ___. Watch our ‘On the Front Line’ video to learn more about CSL Seqirus

Job Description At Redefine Healthcare, we believe in providing all patients with the highest quality of care and compassion. With our dedicated team of Neurosurgeons, Interventional Pain Management Specialists, Orthopedists, Psychiatrists, Physical Therapists, and Chiropractors, we pride ourselves on specializing in continuity of care for our patients. We are excited to add Vascular to our growing list of specialties. Redefine Healthcare is looking for a dedicated, per diem X-Ray Technologist to join our expanding team of healthcare professionals in our West Orange, Edison, Union & Hackensack offices. The X-Ray Technician will perform high-quality imaging procedures, maintain radiology equipment, assist in daily operations, and collaborate with a team to ensure excellent patient care in a dynamic and fast-paced healthcare environment. We are looking for candidates who are motivated, compassionate and are looking to advance their career in a community that is always growing. Job Title: X-Ray Technologist Salary/Pay Rate: $35-45/ hour, depending on specialty and experience Job Type: Per Diem Job Title Duties (not limited to): • Ensure appropriate supplies and equipment are ready and available for scheduled procedures., • Ensure equipment is in proper working condition prior to imaging being performed., • Position/reposition equipment throughout procedures and process fluoroscopy images., • Daily C-arm cleaning/general maintenance., • Maintain QA for Radiology Department: daily warm-up and inspection, phantom images, and quarterly QA testing/logs., • Review/distribute/collect radiation monitoring devices of all OR personnel monthly., • Review radiation monitoring reports and distribute monthly to personnel and the Administrator., • Investigate any radiation exposures that are out of limits for monthly, quarterly, or yearly time periods., • Perform standard x-ray imaging as ordered in-house by providers., • Other radiology-related tasks may be assigned. Minimum Level of Education or Experience Required: • Bachelor's or associate's degree in radiologic technology, radiology, or a related field., • Appropriate state licensure., • Proven experience working as an X-ray technician., • Working knowledge of radiographic equipment., • Ability to move or lift patients., • Excellent analytical and problem-solving skills., • Effective written and verbal communication skills., • Ability to navigate health EHR systems., • Familiarity with medical terminology.

Job DescriptionCompany Description Derex Technologies Inc specializes in providing IT consulting, staffing solutions and software services. Globally headquartered in Harrison New Jersey since 1996 Derex delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results to global clients throughout North America. With over two decades of unparalleled experience, Derex provides supports to its clientele, across such industries as Systems Integration, Banking and Finance, Telecommunications, Pharmaceutical and Life Sciences, Energy, Healthcare, Technology, Transportation, and local and federal Government agencies. Job Description Job Title: Business Analyst – Interoperability Location: Parsippany, NJ (On-Site) Full Time Job Overview As we grow, we seek a detail-oriented, self-motivated, independent Business Analyst with strong domain expertise in FHIR (Fast Healthcare Interoperability Resources), Electronic Medical Records (EMR), and Healthcare Interoperability. Job Responsibilities Key Experience Areas: FHIR Standards & API Integration: * • Proven experience working with HL7 FHIR specifications, including resource modeling, API design, and implementation for clinical data exchange., • Lead requirements gathering and gap analysis for FHIR-based APIs to support patient data exchange across systems., • Collaborated with development teams to define resource mappings and ensure compliance with HL7 standards., • Participated in testing and validating FHIR endpoints for clinical and administrative data. EMR Systems: * • Hands-on experience with leading EMR platforms like Epic, Cerner, or Allscripts. Ability to analyze workflows, extract structured/unstructured data, and support integration efforts., • Worked with multiple EMR platforms (e.g., Epic, Cerner, Allscripts) to extract and normalize patient data for downstream processing., • Defined workflows for integrating EMR data into analytics platforms and care coordination tools., • Partnered with clinical stakeholders to ensure EMR configurations aligned with operational needs and regulatory requirements. Healthcare Interoperability: * • Deep understanding of interoperability frameworks, including CMS and ONC mandates, 21st Century Cures Act compliance, and payer-provider data exchange. Experience facilitating seamless data flow across systems using secure protocols and standardized formats., • Supported initiatives aligned with CMS and ONC interoperability mandates, including 21st Century Cures Act compliance., • Facilitated data exchange between payers, providers, and third-party applications using APIs and secure transport protocols., • Conducted impact assessments and documentation for interoperability enhancements, including patient access and provider directory services. Business Analysis Skills: * • Strong capabilities in requirements gathering, stakeholder engagement, process mapping, and documentation. Experience working in Agile environments and collaborating with cross-functional teams including developers, QA, and product owners. Desired Skills • Strong verbal and written communication skills, • Familiarity with utilization management processes, preferably prior authorization within all lines of business, • Experience working with health plans, PBM, and specialty pharmacies is a plus., • Problem-solving and business analysis skills with strong attention to detail, • Strong execution skills, • Highly organized and flexible, • Team Player Qualifications • Three plus years working as a Business Analyst, • Bachelor's Degree required., • Experience working with MS Office products., • Authorized to work in the USA without Sponsorship or Restrictions. Key Competencies Communicates effectively – Attentively listens to others, provides timely and helpful information, and is effective in various professional settings. Demonstrates excellent oral and written communication skills. Able to communicate effectively with all levels of the organization, from staff to senior leadership. Being resilient - Demonstrates grace under pressure; maintains a positive attitude in adversity and rebounds from setbacks. Manages complexity - Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Has strong organizational skills and can manage multiple projects at once. Ensures Accountability - Follows through on commitments and ensures others do the same. Able to work independently and as part of a team Regards, Manoj Derex Technologies INC Contact : 973-834-5005 Ext 206 Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Commissioning Engineer - Wayne, NJ Our client is a Engineering Design and Commissioning Company that is a leader in the data center space. They provide design, commissioning consulting and management expertise in Data Center / Mission Critical Facilities Space with the mindset to provide reliability, energy efficiency, sustainable design and LEED expertise when providing these consulting services for Enterprise, Colocation, and Hyperscale Data Center Projects. This career-growth minded opportunity offers exciting projects with leading-edge technology and innovation as well as competitive salaries and benefits. Execute onsite commissioning plans, provide and gather specifications, and execute assignments in a multidisciplinary engineering Commissioning role for large facility projects. The commissioning experts adhere to a thorough quality management - QM /QA / QC process and procedures that validate and document our client's systems. Commissioning methodology covers a wide range of procedures to verify the integrity and performance of their customer's mission critical support infrastructure. Responsibilities: • Participate in daily commissioning activity meetings which services include:, • Equipment pre-start-up and start-up procedures; Development of standard operating procedures (SOP's) and Methods of Procedures (MOPs); Comprehensive Commissioning documentation, • Prepare commissioning test procedures and reports; Develop and maintain commissioning logs, equipment checklist, and other tools to track commissioning projects; Write comprehensive reports which include the following sections: recommendations for optimizing building operations, functional checklists, list of deficiencies, equipment operation and maintenance manuals, • Review design criteria, specifications, drawings, equipment submittals, and other documentation pertinent to commissioning, • Integrated system testing; Load Bank Testing; Compilation of all testing procedure results, • Develop and administer functional tests for various systems, such as: electrical distribution systems, UPS, standby generators, etc., • System Assembly; Commission plan preparation ; Follow company QC process and procedures, • Help lead and manage any external resources; Schedule and direct periodic commissioning meetings; Attend construction and coordination meetings if required for the project ;, • Interface with clients, contractors, equipment vendors and owners agents as needed; Execute project assignments; Interface with project contractors, vendors, and testing technicians; Interact with all facets of the company: engineering, design, etc., • 2-5+ years experience with Data Center Commissioning, • Bachelor's / Associates Degree as an Electrical Engineer a plus, • Experience commissioning enterprise data centers, colos, and hyperscale companies, • A/E experience working in complex facilities or mission critical projects a big plus, • Previous Data Center / Mission Critical experience a must, • Excellent communication skills, both written and verbal (this role requires heavy amount of writing, documentation, and client interaction), • Equipment testing experience in a Critical Facilities / facility environment, • Previous experience conducting Level 1-5 Commissioning, • Possess basic knowledge of systems design for various projects, • Possess basic knowledge of systems design for various projects, • Experience using Microsoft Word, Excel, and Microsoft Project After applying, if you have further questions, you may call 973-895-5200 and ask for Iggy. You can also submit via our career portal and take a look at other Critical Facility openings we are working on at, If this job is not for you, feel free to forward this along. WE PAY FOR REFERRALS!! Company offers competitive salaries and benefits package including medical insurance, a 401(k) plan EOE/AA Employer M/F/D/V Pkaza LLC is a third-party employment firm. All fees assessed by Pkaza LLC will be paid by our employer that we represent and not by the candidate

Job Description Summary The Quality Validation Specialist will be responsible for ensuring that finished products meet company standards through inspecting, assessing, and testing of products, integrations, and implementations of new equipment and processes. The candidate will support the day-to-day activities pertaining to the lab, customer complaints, environmental monitoring, and validations (equipment, cleaning, process and products). The ideal candidate must understand lab procedures and process validation strategies. The position will report directly to the Lab Supersivor with oversight by the QA Manager. This role offers responsibility, variety and the satisfaction that your role makes a real impact on our success Responsibilities • Assist QA management with implementing various quality systems (SQF, Organic, Kosher, RSPO, UTZ, etc.), • Assist with lab testing, sample collection, sensory evaluation, shelf-life retention monitoring, • Communicate corrective actions to suppliers/vendors., • Assist in implementation of corrective actions required as a result of an audit or internal finding, • Communicate nonconforming products to appropriate personnel., • Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses preventative/corrective actions. Ensure timely closure of investigations., • Participate in internal audits for compliance with SOPs, GMPs, and regulations., • Participates actively in technology transfer, method qualification and validation., • Experienced with GFSI and HACCP Scheme (SQF, BRC), • HACCP and PCQI Certified is not required but a plus, • 1-2 years of relevant work experience in a medical device, pharmaceutical, or food processing industry field., • Knowledge of Regulations and Standards: Familiarity with relevant regulations and standards, such as cGMP (Current Good Manufacturing Practices) GMP experience in manufacturing environment., • Working knowledge of safety rules, regulations and training., • Bilingual (Spanish/English), • Good Communication skills: Ability to communicate effectively with technical and non-technical personnel., • Technical Writing: Intermediate to advance, • Problem-Solving Skills: Ability to identify and resolve issues related to validation activities., • Strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook, • The ability to solve practical problems or issues and report in a high level, • Ability to work in a team environment, • Scientific Background: Typically requires a bachelor's degree in a scientific field, such as biology, chemistry, or engineering., • Technical Proficiency: Familiarity with laboratory equipment and validation techniques, methodologies., • Analytical Skills: Strong analytical skills to evaluate data and identify trends.

Job Description SUMMARY The position of Quality Assurance manager is responsible for all facets of the operation of the Quality Assurance and Food Safety functions. The duties expected include: accurate analysis of samples, recording of results and distribution of results to appropriate individuals, routine shipment of samples to outside laboratories for analyses not performed in house, monitoring product specifications and making changes in product specifications as needed, establishing raw materials blends to meet specifications of flour to be produced, overseeing functional operation of regulatory programs to assure plant compliance, (including HACCP, GMP’s, Master Sanitation Schedules, BRC standards and FDA standards), championing Root Cause/Corrective Action activities. monitoring effectiveness of recalls. Communicating with customers is a vital function performed by the Quality Assurance Manager. Communications include timely submitting of C.O.A.’s to the customer and answering customer questions and complaints. The Quality Assurance Manager will lead all facets of the Quality Assurance Department including Quality Programs, Food Safety, Sanitation Programs, Customer Programs, Data Management, Process Improvement and Laboratory Analyses and will have a staff of Lab Technicians and Food Safety Supervisor working under their direct supervision to help accomplish the above responsibilities. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Maintain compliance with BRC Global Standard for Food Safety, Organic, Gluten-Free, Kosher, and other applicable certifications, including documentation and record-keeping., • Manage raw material blends to ensure adherence to final product specifications., • Collaborate with customers to resolve quality and food safety complaints. Lead root cause analysis and corrective action initiatives., • Monitor, analyze, and report on quality standards, deviations, and cost/value opportunities for all products manufactured at the facility., • Ensure adherence to QA/FS principles, good manufacturing practices, and Corporate Quality Assurance provided by all site departments., • Manage product sampling, laboratory test procedures, and communication of results., • Oversee plant sanitation, regulatory inspections, and the administration of other site-specific pre-requisite programs., • Direct the plant Quality Assurance team, including selection, training, leadership, scheduling, and task assignment., • Serve as the primary escalation point for all Quality Assurance and product testing matters. Make accept/reject decisions on incoming grain/ingredients and outgoing customer shipments., • Provide technical expertise on ingredient quality, specifications, and product performance to all departments, supporting new product setup, label approval, and ingredient systems., • Maintain quality control lab testing equipment by ensuring preventative maintenance programs are adhered to and support troubleshooting when deviations arise., • Lead initiatives supporting Corporate Quality Assurance business plan and site programs (e.g., safety, recognition)., • Provide technical leadership and expertise in Quality Assurance and Testing., • Conduct interviews, onboarding, training, and performance evaluations for the QA team., • Analyze customer needs, develop finished product specifications, and prepare customer ingredient samples., • Collaborate with procurement and suppliers to resolve quality and food safety complaints. Respond to customer quality inquiries. PLANT SPECIFIC DUTIES: • Monthly floor coaching with Plant Manager/Supervisory team in various departments to drive coaching/training efforts with all plant team members., • Food Safety and sanitation position reports to QA Managers QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. • Bachelor's degree in Food Science, Cereal Science, Biology, Chemistry, Milling Science, or a related field., • 5+ years of experience in laboratory management, quality control, or quality assurance., • Technical expertise in all aspects of quality, food safety, and sanitation within food manufacturing., • Strong working knowledge of food plant operations, production equipment, cleaning and sanitizing procedures, and food quality standards (HACCP, USDA, FDA, AOAC, FSMA)., • Communication skills to effectively convey and implement the QA vision with key stakeholders., • Ability to effectively manage conflict., • Decisive leadership skills and a proactive approach., • Experience in employee management, including setting expectations, defining schedules and milestones, conducting performance reviews, and developing career advancement plans., • Proven track record of driving continuous improvement; Lean, Six Sigma, Kaizen, or CQE certification is a plus. Ability to apply mathematical concepts to practical operational situations., • Prior experience in grain milling manufacturing is highly preferred., • Strong problem-solving skills, including the ability to define problems, collect data, establish facts, and draw valid conclusions. Formal root cause analysis training is a plus. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • This position requires the ability to stand and/or walk for extended periods., • Occasional bending, stooping, kneeling, crouching, or crawling may be required., • Frequent sitting at a workstation is expected., • Finger and hand dexterity is necessary for keyboard use and operating laboratory equipment., • Specific vision requirements include close vision, distance vision, color vision, and depth perception. WORK ENVIRONMENT The work environment characteristics described here are representative of those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • This position involves routine exposure to dust and fumes typically found in cereal grain processing facilities and testing laboratories. The laboratory's noise level is generally moderate. Noise levels exceeding 90 decibels should be expected in the production environment. FOOD SAFETY / SECURITY REQUIREMENTS: The Company is committed to producing and delivering defect-free products. To ensure this, all employees are required to be trained on and adhere to the Good Manufacturing Policies set forth by the Company as they pertain to personnel practices, equipment, and facilities. It is also vital that all employees be aware of the work environment and, when possible, prevent accidental or intentional adulteration of products produced at this facility. As a result, any employee has a right to put product on hold if they have concern. At the plant level, only the Quality Assurance Manager and General Manager have the authority to release the product on hold.

Job Description About the Job The primary function of this position is to oversee a full portfolio of approved and unapproved ANDA products. The incumbent might also be designated as U.S. Agent (back-up) for the U.S. Office for both ANDAs (GPI USA) and API (GLS India). The position includes a number of responsibilities that will require excellent communication to support both internal and external customers (globally) including the U.S. FDA. Job Responsibilities Note: These statements are not intended to be an exhaustive list of all responsibilities and duties. • Manage at least one (1) and possibly up to (2) direct reports to ensure their assigned responsibilities are completed accurately and on a timely basis to support the needs of the business for internal/external customers., • Support the U.S. Office for more than 170 approved ANDAs and all unapproved (under review ANDAs) as U.S. Agent back-up for all Glenmark subsidiaries including GPL, GSSA, GPI and GLS. The successful candidate will need to be able to review and sign various submissions to FDA. It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work. Form 2252 for Annual Reports., • Provide support/RA strategy needed to achieve timely approvals with the Agency., • Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and Corresponding Acknowledgements, ANDA Amendments and Responses to CRL (minor/major), DRLs and IRs. The US Office is responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved products, RA India including post-approval team for post-approval activities. The email list is provided for such communications which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management, Demand Planning, Marketing and others identified on the list. It’s very important that these communications be shared with the FDA on a timely basis (typically the same day received from the FDA). Separate communications received from the FDA to support GLS will be sent to the GLS leadership team as identified., • Support OTC submissions, as needed, for ANDA conversion to OTC or OTC Monograph direct including any labeling reviews and updates., • Ensure all manufacturing, packaging, labeling, testing and BA/BE sites are registered with FDA in the CDER Portal, as applicable, • Ensure the payments are made on the scheduled due date to support all manufacturing sites., • Submit all Recalls and FARS to FDA for ANDAs and OTCs, as needed to support commercial. Submit subsequent updates to Recalls / FARS to FDA on a timely basis to meet the required deadline., • Submit controlled correspondences for R&D through CDER NextGen Portal., • Submission of PLAIRS accurately and timely as provided to the US Office., • Shipping samples to the FDA for CDRH evaluation of devices., • Submit pre-ANDA Meeting Packages to FDA, as needed, • Submit Responses to FDA Observations to support manufacturing sites, as needed Qualifications Education • Extensive experience in the pharmaceutical industry with at least 10+ years’ experience in a regulatory affairs., • Primary experience must be managing a significant number of generic drug products (ANDAs & OTCs)., • Capable and has the desire to manage at direct reports, as assigned., • Excellent communication skills including: verbal, reading and writing., • Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports trained according to support labeling., • Proficient using MS word, MS excel, reviewing Drugs@FDA databases, USP database, FDA Orange Book, DP Specifie Bioequivalence Guideline and Dailymed Labeling, • The successful candidate must be proactive in reading and understanding assigned materials including FDA guidance, 21 CFR, USP general chapters, USP specific monographs, and internal SOPs as assigned., • The candidate must be a highly motivated, willing to be trained and be a self-learner in order to execute assigned tasks with attention to the details., • This will require direct prior experience doing the described activities., • It will in some instances require training, reading internal Standard Operating Procedures (SOPs), in-person training, and training by viewing FDA SBIA learning on-line video seminars or reading FDA guidance., • Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly., • Communicate with Supervisor and other Sr. Management on a timely basis when potential issues/concerns arise., • Use critical thinking skills and attention to detail is essential., • Ask questions and/or advice when in doubt., • The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties., • The noise level in the work environment is typical of that of an office, • Incumbent may encounter frequent interruptions throughout the workday. Salary Range - $160,000 – 185,000 The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. Benefits include: • Paid time off, • 401k plus company match, • Company paid health benefits, • Dental, • Vision, • Onsite access to company gym, • Paid Employee Referral Program, • EAP – Employee Assistance Program, • Accident Insurance, • Critical Illness Insurance, • Short-Term Disability, • Life and AD & D Insurance, • Whole Life Insurance, • Pet Insurance and so much more! About the Company Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live. This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice. Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Description SUMMARY The Senior Manager of Quality Assurance (QA) serves as a key contributor to the Milling and Ingredient Solutions Business Unit (MIS BU) and is responsible for assisting in the development and supporting the execution of strategic direction for the Quality Assurance area in alignment with Business Unit objectives, with shared accountability for business results and financial targets. This role also serves as a member of the Corporate Quality Assurance (CQA) team, and in that capacity, is responsible for the overall Food Safety and Quality Assurance programs at MIS sites to deliver a finished product that meets or exceeds the requirements of Bay State Milling Company, Regulatory Authorities, Customer expectations, and Industry standards. This includes standardization of QA protocols and product specifications across sites, deepening knowledge of supplier programs and practices, consistency in establishment of testing schedules and auditing, as well as evaluation of laboratory capabilities and resource needs. The Senior Manager QA – MIS partners with the plant managers in respective region (East or West) to provide direction, coaching, training, skill development, and input on performance evaluations for each location’s QA Manager and their teams. A key requirement for successful execution of this role is working collaboratively within the function to stay abreast of BSM, regulatory, customer, and industry standards and working cross-functionally to understand all perspectives relative to business decisions. The Senior Manager serves as a technical expert for Wheat Flour and/or Seed and Grain products as well as supply chains to external and internal customers. This role supports the QA Director in the establishment of performance standards and holds responsibility to implement policy across the assigned sites to ensure a consistent customer experience and to continuously improve quality assurance programs. Further, the Senior Manager QA ensures facility teams are prepared to execute against all applicable certifications including organic, kosher, Global Food Safety Initiative (GFSI), and Non GMO Project Verification. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Perform all tasks safely and efficiently. Quality/Food Safety • This position is responsible for monitoring and improving the overall Food Safety and Quality programs at assigned sites. This includes standardization of QA protocols, testing schedules, and product specifications across sites., • Responsible for establishing and improving protocols at all sites in respective region to evaluate inbound raw materials and packaging materials, as well as in-process and outbound products, • Guide QA managers as needed through root cause investigation and CAPA setting in case of quality deviations, • Has the authority to make ship/no ship decisions in case of quality events., • Stays abreast of relevant food safety and quality standards through participation in industry associations, training, and engagement with internal and external experts., • In conjunction with the Director of QA, establishes and executes on food safety and quality policies across applicable facilities to ensure compliance with company, regulatory, customer and industry standards., • Complete and successfully prepare for audits for compliance against BSM and industry standards.., • Collaborates with other business units in sharing of best practices, policies and procedures to ensure alignment Company wide., • Leverages Cultivating Excellence activities to drive continuous improvement of programs. This includes actively leading or participating in Corporate QA (incl CE) projects when business needs arise., • Provides technical direction regarding EMP development and monitoring, equipment cleaning and sanitizing, and employee practices. Provides guidance or direction as needed to plant QA teams to address any non-conformances., • Develops, monitors, and reports on key metrics to Wheat Flour or S&G tactical leadership and Director of QA., • Ensures plant teams receive sufficient direction, training and resources to consistently execute quality programs and successfully complete relevant certifications, including organic, kosher, gluten free, Global Food Safety Initiative (GFSI), and Non GMO Project Verification. Pipeline Management • Supports risk assessments of ingredients and vendors in alignment with Food Safety Modernization Act requirements. Provides follow up as necessary., • Partnering with respective QA manager(s) and Supply Chain peers, evaluates supplier performance trends and makes recommendations for improvement, teaming up with suppliers as needed to address gaps., • Serves as a key technical resource regarding Wheat Flour and/or Seed and Grain (S&G) products and supply chains to external and internal customers., • Partners with supply chain and provides direction to QA teams at assigned sites regarding management of relevant supply chains. Customer • Reviews customer specifications and provides input to Sales and the Customer., • Evaluates Cultivating Excellence Relationship Tool to identify trends in internal incidents, vendor incidents, and customer complaints. Reports on performance and leads teams to investigate and prevent future recurrences., • Actively seeks opportunities to engage and build proactive, trust-based relationships with customers. Plant/Business Unit • Provides input to establish and execute business plans for both CQA and the MIS business BU., • Serves as a key member of the CQA and potentially one of the tactical MIS Leadership teams with responsibility for tactical execution of the business, and cross-functional collaboration to deliver on identified business results and financial targets. Leads initiatives to deliver against objectives., • Ensure Quality team has adequate ERP support through a network of Quality AX / D365 SME’s; provide input to needed enhancements to increase team effectiveness and efficiency. Technical Service • Develops and demonstrates an understanding of how our customers utilize BSM products., • Serve as the first point of contact for non-routine customer inquiries and questions relating to food safety and quality of products at assigned Wheat Flour locations. Ensure technical assistance to customers as requested. Partner with Technical Services to provide troubleshooting support when necessary for plants or customers., • Support Sales teams with technical understanding of products for customer and business development. Supervisory Responsibilities • Directly supervises the QA Managers at the assigned locations. In this capacity, establishes annual objectives, provides coaching, supervision, performance evaluations, and develops training and skill enhancement plans for employees., • Assesses talent needs and makes recommendations as appropriate., • Encouraged to actively seek out and lead cost savings or, on the other hand, evaluate technical QA investment opportunities for applicable sites on a regular basis. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPERIENCE • Bachelor’s Degree in Food Science, Cereal Science, Biology, Chemistry, Milling Science or equivalent., • Minimum of 8 years of experience in Manufacturing QA required., • 5 or more years of previous Supervisory or Management experience required, • Green Belt certification in Lean/Six Sigma preferred., • Laboratory experience preferred, • Experience in the grain business will be taken into consideration on a case-by-case basis. LANGUAGE SKILLS Capable of following and communicating written and verbal instructions in English. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write in English and complete reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, customers, and top management, public groups, and/or boards of directors. MATHEMATICAL SKILLS Must have the ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals, as well as, ability to compute rates and percentages. OTHER SKILLS AND ABILITIES Delineation of Accept/Reject Decisions: The Sr. Manager - QA has the authority to enforce all Corporate QA Standards. If an employee is in disagreement with her/his decision, the Director of QA will be consulted. If there is still a disagreement, a joint decision will be made by Sr. Director of QA and the Milling and Ingredient (MIS) General Manager. If there is still not consensus, the final decision will be made by the President & CEO of BSM. CERTIFICATES, LICENSES, REGISTRATIONS Ability to utilize computer programs including e-mail, word processing, and spreadsheet applications such as Excel, and AX ERP system. In addition, the ability to review process and determine best approach or fix/solutions to increase efficiency in the role. SAFETY While performing the essential job functions, the employee is expected to work in a safe manner and follow company policies regarding safety. It is the expectation and responsibility of the employee to report any and all injuries immediately to the supervisor, and to report to supervision any safety situation that the employee feels is substandard and poses a risk for employee injury, property damage, or loss. TEAMWORK Must have team building skills; also, must have ability to work independently and cooperatively across functions. DEPENDABILITY Follows through on tasks; requires minimum supervision and follows instructions and procedures. Arrives at work on time; follows Company policies on vacations, leaves, etc. Observes Company rules; completes tasks within deadlines. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Willingness to cooperate with peers to accomplish work assignments and maintain effective working relationships; demonstrate respect and consideration for others' opinions; contribute to the overall task of the team. Will follow Company policies, procedures and work rules. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle or feel objects, tools, or controls; and talk or hear. Specific vision abilities required by this job include close vision, distance vision, and the ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, use hands to figure, handle, or feel; reach with hands and arms; and talk and hear. Employee is frequently required to stand, walk, climb or balance, and must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to focus. FOOD SAFETY/SECURITY REQUIREMENTS The company is committed to producing and delivering defect-free products. To ensure this, all employees are required to be trained on and adhere to the Good Manufacturing Policies set forth by the Company as they pertain to personnel practices, equipment, and facilities. It is also vital that all employees be aware of their work environment and prevents any accidental or intentional adulteration of products produced at this facility.

Job Description PER DIEM OPPORTUNITIES AVAILABLE Onsite Women's Health is on a mission to improve women's healthcare. In partnership with forward-thinking providers across the country, Onsite Women's Health offers comprehensive mammography services with clinical expertise, innovative technology, and proprietary protocols that delivers personalized, convenient breast care for the patient. Convenience drives compliance, and compliance saves lives.Convenience is critical to ensure that most women have time to remain compliant with their breast care. By offering mammography and breast care within the patient's primary care or OB/GYN practice and scheduling appointments in coordination with an annual exam, compliance is easier to accomplish. The Opportunity The OWH program is unparalleled, making breast cancer screening more convenient for women. Do you want a flexible work schedule? Can you be available to cover on a moment's notice? Do you want to experience different office environments? Then come to Onsite Women's Health as a Per Diem Technologist! See yourself here. At Onsite we don't work weekends or after hours and offer the opportunity to use the latest 3D tomosynthesis digital mammography equipment in an OB/Gyn office environment. If you are an experienced mammographer, someone who can work independently and wants to have an impact on each and every patient, join us as a Per Diem. What do you need to be the right candidate for this role? • Must be up to date on all CME credits., • Must be very patient centric, compassionate, and computer savvy., • Able to perform a variety of technical activities associated with the performance of screening and diagnostic mammography procedures., • Flexible with the ability to multi-task., • Specializes in the production of screening and diagnostic mammograms for the detection of breast cancers and lesions., • Responsible for the initial and ongoing success of the mammography service in the practice in which one works. Assist practice in any and all ways possible to be sure all eligible age-appropriate patients have annual screening mammograms., • Prepares patients for the mammographic procedure., • Explains procedures to the patient to reduce anxieties and obtain patient cooperation., • Moves mammographic equipment to specific positions and adjusts controls to set exposure factors based on knowledge of radiographic exposure techniques and protocols., • Practices radiation protection techniques by using beam restrictive devices, patient shielding skills., • Follows prescribed safety standards in operating all required equipment., • Examines digital images for image quality., • Ensures equipment is in proper working order at all times., • Performs all required QA testing required to comply with MQSA, ACR and State requirements/regulations., • Maintains patient confidentiality at all times., • Processes routine paperwork and all required data entry., • Participates in professional development activities and maintains professional affiliations., • Prepares all required reports and data pursuant to MQSA and State requirements., • Assists the Radiologist with QA/QC reporting., • Performs all mammography tracking following MQSA guidelines and requirements., • Maintains all QA documents necessary to exceed Annual FDA Inspection requirements. Experience: Job Posted by ApplicantPro

Job Description Job Summary: The EVP, Scientific Affairs oversees the operations of the Quality Assurance and Quality Control Departments for all divisions across multiple locations and has overall responsibility for the technical operations and the strategic planning of adequate resources needed to ensure the required quality of laboratory operations meet business requirements and customer deliverables. They will develop, implement, and periodically evaluate the QC/QA Department activities to ensure the organization’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization to meet the requirements of customers, consumers, and regulatory and accrediting agencies. The role is also responsible for ensuring cGMP compliance across all business divisions within the Company. The EVP, Scientific Affairs will be accountable for the timely release of products at all steps of the Manufacturing process, based on justifiable rationale, valid scientific data, process control items, etc. Principle Responsibilities: • Directs all Scientific Affairs and assumes responsibility for all Quality related matters; sets priorities and oversees the daily efforts of the QC/QA Team., • Provides guidance and works with various Departments in maintaining cGMP compliance within all business divisions of the Company., • Initiates Quality processes that drive continual improvement within the organization., • Conducts internal quality control audits and random inspections of each site’s Quality Management System as required and periodically reports on status of quality control and operations to executive leadership and, when required, regulatory agencies., • Provides support for third party cGMP certification audits and ensures appropriate corrective actions are conducted., • Directly involved with on-site regulatory (FDA, NJ-DHHS, etc.) inspections as well as internal and third-party audits and writing and overseeing responses to audits to comply with cGMP and GLP. Serves as the contact person and co-hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations., • Facilitates communication among production divisions and management. Provides support to Manufacturing and Product Development as required to troubleshoot production problems and collaborates with management and senior staff across production departments and roles to draft acceptable quality standards., • Evaluates internal and external laboratory capabilities. Recommends new testing procedures and equipment to support cGMP and customer specific requirements., • Develops and implement standards, methods, and procedures for inspection and testing, validation of systems and analytical processes, documentation, and change control systems that ensure the identity, purity, strength, and composition of ingredients and finished products are to specifications., • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements and monitor the compliance through robust internal audit program., • Ensures all laboratory controls and functions and all Quality Control functions as designated in 21 CFR GMP Part 110, 111 and 117 are in place, documented, monitored and enforced to maintain the QC Lab within a cGLP environment at all times., • Assess test results and approve recommended changes., • Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance., • Select, upkeep, calibrate, recertify, and document all instrumentation in the QC lab., • Oversee lot release of components, raw materials, and finished products., • Develop raw material specifications and finished product specifications once material has been through the Product Development process and route for signature., • Ensure sampling and testing priorities are consistent with Manufacturing, Production, and Customer Service schedules., • Preparation of analytical documentation (OOS, deviation reports, test methods, change controls, Certificate of Analysis) for incoming raw materials and finished goods., • Review technical control documentation (SOPs, Batch Records, test methods, specifications, COAs, etc.) from a Quality and Compliance perspective; ensure continuous improvement of departmental SOPs to stay up to date with regulatory and compliance guidelines; create, revise, and gain approval to implement lab SOPs and procedures and to review qualification documents for laboratory instrument/software as is necessary., • Maintain and improve department performance to meet requirements of Regulatory Authorities as well as the policies and standard procedures of the company., • Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories., • Provide technical guidance for validation of analytical methods and develop overall strategy to manage all critical reagents, reference standard, and reference control materials used in the laboratory., • Establish proper communication channels to manage, mentor direct reports to higher levels of management capability and provide strategic leadership to further strengthen the platform with a highly functional QC team., • Plan strategically/proactively with management of other platforms to ensure that resources are allocated adequately to meet each program’s needs., • Ensure that QC decisions are aligned with governance from Company Procedures and regulatory requirements., • Coordinate management structure of the laboratory to build Analytical datasets (release, and analytical verification) for Starting materials, In Process and Finished goods., • Identify gaps and assist with annual budget at both CAPEX and Operation levels. Direct – AVP, VP or Director of QC, QC/QA Team Indirect – Production Staff Supervisory Responsibilities: • Directs and oversees the quality control and quality assurance departments and supervisory staff., • Train QC/QA Team as necessary and validate their work periodically., • Perform annual performance reviews that are timely and productive and develop training plans with direct reports., • Handle discipline and termination of employees in accordance with company policy., • Ensure staff are provided with corporate communications. To perform this job successfully, an individual must be able to perform each principal responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education: BS degree in Chemistry, Engineering or Life Sciences required. Advanced degree preferred. Experience: 10 years in the manufacturing QC/QA field with a minimum of 5 years supervisory experience directing QC/QA and Documentation function within the Nutraceutical or Dietary Supplements industry is required. Solid overall knowledge of USP, FCC, and FDA guidelines as applied to testing of cosmetic and dietary supplement ingredients and finished goods. Experience leading FDA inspections is highly desirable. The desirable candidate will also be knowledgeable in analytical instrumentation (i.e., HPLC, GC, UV-Vis, FT-IR, Atomic Absorption, TLC and USP dissolution apparatus 1 and 2). Working knowledge of product stability studies and microbiological analysis of raw materials, in-process and finished goods required. Physical Requirements: Work requires ability to lift up to 25 pounds; sitting, standing, walking, bending and/or stooping for periods of five hours or more; moving and examining objects at high and low reach, and reading for periods of three hours or more; prolonged periods working on a computer. Position requires normal visual acuity. Additional Skills and Qualifications: Proven experience managing technical services and staff. Demonstrated knowledge of current cGMP requirements, regulations and standards to ensure the maintenance of the cGMP standard of quality. Thorough understanding of quality control standards and methodologies. Thorough understanding of manufacturing and production in the industry. Ability to read and interpret documents such as safety rules, operating and maintenance work instructions, procedure manuals and SDS sheets. Must have the ability to communicate effectively orally and in written form. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals. Must understand and use advanced statistical methods. Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Must have ability to solve complex problems involving multiple variables in standardized situations. Must have a deliberate and acute sense of documentation of all activities while in the manufacturing environment. Must be proficient with and be able to communicate via e-mail. Must be proficient with and able to use computer software including word processors & spreadsheets (Microsoft Word, Excel, Access), and ERP System. Proficient in oral and written communication skills. Must be able to communicate effectively in a cross functional team environment to complete work tasks as instructed. Must have sound judgment and decision-making skills. Excellent organizational skills and demonstrated attention to detail and thoroughness are critical. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Vital Health America is an Equal Opportunity Employer Company DescriptionVital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.Vital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.

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Design, develop, and implement QA standards, methods, and procedures for evaluating hardware, software, and service products. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law.