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Supplier Quality Engineer Overview: The Supplier Quality Engineer (SQE) position is responsible to develop positive, partner-oriented relationships with members of MCI’s Supply Chain to continuously improve and monitor supplier performance through auditing and the application of quality tools and performance metrics. The SQE must be a self-motivated individual who possesses the ability to analyze, organize, plan and prioritize assignments/tasks to achieve desired results. This position requires effective interaction with a broad spectrum of people to successfully support operations, customer requirements and the corporate strategic vision. Main job responsibilities: • Identify improvement projects and manages cross functional implementation to improve supply chain performance, • Promote the use of Quality tools and continuous improvement techniques at suppliers to reduce variability, achieve process control and improve the overall quality of processes, systems and MCI’s product(s)/materials., • Develop positive relationships and effective lines of communication with suppliers (partnership-oriented), • Train suppliers to effectively execute Supplier Corrective Action Requests (SCAR), Quality Alerts, Corrective/Preventive Actions (CAPA) implementation, change control and root cause analysis, • Perform periodic audits and evaluate Supplier Quality Systems/processes and flow down of customer requirements to assure conformance to requirements., • Collect and evaluate supplier quality data and performance metrics to manage the Supply Chain score card system., • Recommend suppliers for qualification and/or disqualification based on quality performance, • Evaluate supplier processes, collaborate with suppliers on process improvement and value enhanced opportunities, • Ensure effective communication with MCI Engineering, Operations, Quality Engineering and Procurement to identify opportunities for quality and productivity improvements, • Working directly with suppliers, create corrective action plans and effectively resolve identified issues, • Organize and assume a lead role in presenting the status of “Active Supplier Quality” issues, • Ability to provide training in an effective manner, • Foster a positive, cooperative, and safe work environment through effective communication at all levels of the Marotta organization, • Abide by all safety, quality, housekeeping and company policies/procedures to ensure compliance to various regulatory and internal system requirements Additional job responsibilities: • Foster a positive, cooperative and safe work environment through effective communication at all levels of the Marotta organization, • Abide by all safety, quality, housekeeping and company policies/procedures to ensure compliance to various regulatory and internal system requirements Minimum Requirements: • Minimum of a bachelor’s degree in Mechanical/Electrical/Manufacturing Engineering, • Knowledge of, or experience in a manufacturing/testing environment (Aerospace preferred) Knowledge in the areas of Circuit Card Assemblies (CCA’s) inclusive of IPC J STD-001E/NASA STD-8739 and IPC 610 standards and requirements, • Knowledge of Machining and Measurement processes and equipment., • Minimum of (1) year Quality/Design/Manufacturing Engineering Experience – Supplier Quality field experience preferred, • Knowledge of, or experienced in the areas of special processes (ex. plating, painting, weld, etc.), AS9100 & ISO system standards/requirements, P.O. review/approval, ESD, Foreign Object Debris/damage (FOD) Controls, performance metrics and System/Process audits, • Ability to interpret Military, Commercial aircraft and Space level specifications, dwg’s, and standards, • Knowledge of, or demonstrated track record in the area of Lean concepts, variability analysis, SPC/Process controls, root cause analysis, failure Mode Effects Analysis (FMEA), Six Sigma tools, System/Process auditing, etc., • Knowledge of or experienced use of various measuring/inspection instruments (Coordinate Measuring Machine (CMM), Vision System, mechanical instruments, etc.), • This position requires the eligibility to obtain a security clearance, therefore you must be able to obtain/maintain a security clearance, • Must be a US Citizen Other job requirements: • Must be Computer literate (MS Excel/Word/PowerPoint), flow chart and statistical/analytical software packages, • Strong interpersonal, written, time management, analytical, statistical, problem solving, communication and organizational skills, • Demonstrate the ability to read, interpret documents (i.e. procedures, schematics/technical drawings, etc.), • Position requires a detail-oriented individual who can multi-task, provide leadership (project/assignment related), work in a fast-paced environment and communicate issues in a timely/effective manner. Work Environment: • While performing the duties of this job, the employee is potentially exposed to conditions typical of a manufacturing/machine shop environment, including, but not limited to fluids, fumes or airborne particles, moving mechanical parts, noise and vibration, • This job interacts both in a professional office environment and a manufacturing/machine shop environment. This role uses standard office equipment such as computers, phones, printers/scanners/copier machine, as well as environments inclusive of the appropriate eye, hearing and foot protection (as required)., • Some travel may be required for this position (50% travel), • Full time position Physical Requirements: • While performing the duties of this job, the employee is regularly required to talk and hear., • The employee is frequently required to reach with hands and arms, and to use hands to finger, handle or feel., • Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus., • This position requires the ability to skillfully use measuring instruments, hand tools, • The employee may be required to lift, push, pull and/or move items weighing up to 50 pounds Salary - $87,500 - $115, 000 We offer a highly competitive compensation package for this outstanding position plus a quarterly bonus along with a full range of top quality benefits and employee services including: medical, prescription, dental, vision, life and disability income insurance programs, 401k retirement plans with company match, generous tuition aid program, paid vacation, sick and personal days, paid holidays and flexible work hours with compressed work week options. We recognize and reward our employee's accomplishments and host several employee engagement events per quarter. This position is at our Parsippany, NJ corporate offices location. Many of our contracts require proof that you are a U.S. citizen and/or that an export license has been obtained for employees who are citizens of certain countries. Your employment, both initially and continually thereafter, is conditioned on production of such proof of citizenship and/or any export license that may be required to comply with any and all applicable laws, regulations, or executive orders, or required by Federal, State, or local government contracts. If you are looking to grow or accelerate your career and be part of a best-in-class organization while enjoying a work-life balance, please apply! We are an Affirmative Action and Equal Opportunity employer M/F/IWD/Veterans VETERANS ARE ENCOURAGED TO APPLY As a Federal Contractor, Marotta is required to have all employees vaccinated against COVID-19 or qualify for a religious or medical exemption. No agencies, please.

Job Description Company Overview: BioMatrix is a nationwide, independently-owned infusion pharmacy with decades of experience supporting patients on specialty medication. Our compassionate care team helps patients navigate the often-challenging healthcare environment. We treat our patients like family and get them started on therapy quickly. We work closely with them as well as their family and their healthcare providers throughout the patient journey, staying focused on optimal clinical outcomes. At BioMatrix the heart of our Inclusion, Diversity, Equity, & Access (IDEA) philosophy is the commitment to cultivate a welcoming space where everyone’s contributions are acknowledged and celebrated. Our goal is to draw in, develop, engage, and retain talented, high-performing individuals from diverse backgrounds and viewpoints. We believe that both respecting and embracing diversity enriches the experiences and successes of our patients, employees, and partners. Pharmacist License Needed: New Jersey Schedule & Location: It is anticipated that an incumbent in this role will work on-site in our Totowa, NJ location. It is anticipated that an incumbent in this role will work Monday through Friday from 8:30am Eastern Standard Time To 5pm Eastern Standard Time. Work location and schedule are subject to change based on business needs. The Pharmacist-in-Charge is a licensed professional who is responsible for providing safe and appropriate pharmacy services to BioMatrix patients in accordance with the policies and procedures of the, BioMatrix, pharmacy practice professional standards, and applicable regulatory entities. The Pharmacist coordinates patient services with the Nursing Department, monitors patient progress toward goals and educates patients, caregivers, staff and other professionals regarding appropriate medication use. The Pharmacist-in-Charge performs specified distributive and clinical pharmacy activities and related services as they pertain to the quality care of the parenteral infusion therapy/ specialty pharmacy patient. The pharmacist will perform additional pharmacy operation responsibilities as assigned by the Associate Director of Pharmacy Services or VP of Infusion Pharmacy Services. QUALIFICATION REQUIREMENTS • Doctor of Pharmacy degree is preferred or Bachelor of Science degree from an ACPE accredited School of Pharmacy., • At least 3 years pharmacy experience and knowledge of one or more of the following specialty pharmacy, infusion pharmacy (sterile, non-sterile, hazardous, non-hazardous compounding)., • A pharmacist license in good standing with the Board of Pharmacy in the state pharmacy resides in at a minimum, multiple licenses are preferred., • A current, unrestricted, in good standing Pharmacy license as granted by the Board of Pharmacy., • A minimum of one to two years home infusion therapy, specialty pharmacy experience or minimum of 2 years clinical hospital experience in compounding (non-hazardous, hazardous, sterile, non-sterile), transplant, Hepatitis C, hemophilia, multiple sclerosis, neurology, immunology, rheumatoid arthritis/psoriasis, Crohn’s/ulcerative colitis nutritional support, oncology, and infectious disease., • Experience providing customer service to internal and external customers, including meeting quality standards for services, and evaluation of customer satisfaction., • Basic level skill in Microsoft Office (including Word, Excel, PowerPoint, etc.)., • Completion of a Post Graduate residency program preferred but not required, • At least 3 years of experience in home care, specialty pharmacy or hospital setting., • Maintains policies and other standards established by the pharmacy., • Performs initial patient evaluation and reassessments as it pertains to the following:, • Assumes delegated responsibilities for the management of drug therapies., • Collects, analyzes, interprets and evaluates appropriate data necessary to identify the patient's drug therapy needs, drug interactions, unusual doses, allergies, adverse reactions/side effects, response to therapy, compliance to therapy, etc., • Obtains histories and applies these theories with those taken by others and other patient data to optimize drug therapy management., • Sets therapeutics objectives and monitors patients for desired therapeutic response in order to design and utilize acceptable drug therapy management., • Interprets data for objective assessment of physiological functions in order to monitor the effects of drug therapy., • Evaluates the significance of signs or symptoms related to certain disease processes to make recommendations for the modification of drug therapy to these problems and to contribute to their prevention., • Assists the referring physician and institution in planning and implementing patient care to ensure a smooth transition from the hospital to the home., • Assists home patients in the self-management of home infusion/specialty pharmacy therapy., • Conducts patient calls to perform any patient assessments., • Provides counseling and answers questions from patients, family and health care professionals concerning the drug therapy., • Assists in the evaluation and management of problems, which may arise due to the psychological, social and economic aspects of therapies., • Maintains thorough and appropriate documentation in the patient's medical records of all communications and telephone contacts with the patient and their physician., • Prepares progress reports for the referring physicians, insurance provider and others when needed., • Supervises or directly compounds and dispenses pharmaceuticals and related ancillary supplies in accordance with federal, state and local laws and standards of practices within the profession., • Processes and checks all medications, supplies, and equipment prior to dispensing from the pharmacy., • Assists in purchasing, receiving, inventorying and storing of pharmaceuticals., • Assists in special projects and clinical research as directed., • Maintains proficiency in the skills and theory of home infusion and specialty pharmacy therapies by reviewing the literature and attending in-services, seminars, and conferences., • Participates in "on-call” rotation., • Participates in quality assurance activities and audits as directed., • Performs related duties as requested., • Experience and a strong knowledge base in intravenous admixture., • Must be capable of assuming responsibilities in the monitoring and management of nutritional support and drug therapy relative to the total needs of the home care patient in collaboration with physicians, nurses, and other health care professionals., • Must be flexible with work schedules including on-call coverage., • Must be capable of assuming responsibilities in the monitoring and management of nutritional support and drug therapy relative to the total needs of the home care patient in collaboration with physicians, nurses, and other health care professionals., • Experience and a strong knowledge base in intravenous admixture., • Participation and membership in professional societies and organizations is desirable., • Knowledge of the principles and practices involved in compounding and dispensing of prescriptions., • Knowledge of pharmacy, drug, narcotic, and related laws and regulations of the state board of pharmacy and respective prescription monitoring programs, along with federal laws and accreditation standards., • Knowledge of pharmaceuticals, drugs, narcotics, and poisons., • Knowledge of the calculation of doses and the preparation and use of percentage and stock solutions., • Knowledge of the basic sciences underlying pharmacy, such as chemistry, biology, and physics., • Knowledge of the processes involved in the manufacture of pharmaceutical preparations., • Knowledge of stock control and related record keeping., • Ability to apply safety and efficiency in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness and the maintenance and management of health., • Ability to fill prescriptions and prepare official drugs and standard medications., • Ability to recognize physical, chemical, and therapeutic incompatibilities., • Ability to analyze and understand Physicians' or other recognized, medical personnel's oral or written orders involving standard symbols and terminology., • Ability to apply pharmaceutical laboratory techniques., • Ability to maintain accurate records and prepare reports and correspondence related to the work., • Ability to maintain favorable public relations., • Ability to organize and coordinate the work of others., • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings., • This position requires constant sitting with occasional walking, standing, kneeling or stooping., • This position requires the use of hands to fingers, handle or feel objects and the ability to reach with hands and arms., • This position requires constant talking and listening., • Specific vision abilities required by this job include close vision and the ability to adjust focus., • Will participate in legal and ethical compliance training each year., • Will consistently behave in compliance with the BioMatrix legal and ethical policies and procedures., • Will abide by the policies of BioMatrix as set forth in the Compliance Manual., • Will not participate in any conduct considered to be unethical or illegal. EXPECTATION FOR ALL EMPLOYEES Supports the organization's mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect personalization, commitment to our community, and accountability and ownership. GENERAL INFORMATION: The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of personnel so classified. The incumbent must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate. Incumbents within this position may be required to assist or find appropriate assistance to make accommodations for disabled individuals in order to ensure access to the organization's services (may include: visitors, patients, employees, or others).

Job DescriptionTitle: Quality Systems Engineer Reports to: Quality Systems Manager Department: Quality Assurance / Quality Control Supervises: Validation Technician (s) and Quality Associates Organizational Relationships: Contact with all areas of QA/QC, R&D, Purchasing, Operations, Process Engineering, Warehouse, Customers, and other area personnel. Responsibility Summary: The Quality Systems Engineer will perform Process Validation and Cleaning & Sanitization Validation under quality systems to ensure compliance. They will maintain formal drug stability programs, bulk hold studies, product compatibility, SOP binders, supplier and vendor qualification programs, and participate in IQOQ including Risk Assessment of Quality Systems. Responsibilities: The Quality Systems Engineer is responsible for supporting the company's business events through a variety of tasks, including: • Reviews and approves/confirms all new formulas in the Quality Systems., • Design and author protocols and reports to support qualifications, validation and designs of experiments., • Perform capability analysis and trending to support validation and qualifications., • Co-ordinates process validation and product stability programs and maintain associated reports., • Conducts Annual Drug Reviews and Device History Reviews., • Maintains regulatory documents and all documents of external origin., • Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods., • Participates in internal and external audit process., • Participates in product recall audits., • Complies with 21 CFR Part 210, 211 & 820.Perform other duties as assigned by the manager., • Perform Process Validation and Cleaning & Sanitization Validation under the quality systems to ensure compliance., • Maintains formal drug stability program, bulk hold studies, and product compatibility by coordinating samples submission, testing, result retrieval and program review., • Maintains files and database of customer-approvals and documents as evidence of authenticity., • Effects changes to specification sheets as approved through proper change control requests., • Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications., • Maintains copies of approved change controls as applicable to product specification updates/revisions., • Maintains SOP binders and updates such through approved CCs., • Communicates new and updated SOPs to all employees at EWL., • Maintain suppliers and vendors qualification program., • Participate in IQOQ including Risk Assessment of Quality Systems., • Perform annual drug and device history reviews., • Associate’s degree (2-year college degree) required., • Previous experience in Pharma, Cosmetics, food, medical device, or allied profession preferred., • Good Technical Writing ability., • Excellent knowledge of Word, Excel, Access, and other Windows-based programs., • Good record-keeping skills. Compensation & Benefits: The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, Vision, Life, • PTO, • Special Paid Leave for employees’ personal events, • Company Paid Holidays, • 401(k) employer match, • Year-End Gift Powered by JazzHR w53EO6ptBL

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