ADMA Biologics jobs

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an BioCenter Quality Assurance Specialist. Job Title: Specialist, Quality Assurance : This position is responsible to ensure all center activities are performed in accordance with standard operating procedures (SOPs) and the center is ready for inspection by regulatory agencies at any time. The Quality Assurance Specialist (QAS) assists in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed in an effort to reduce or eliminate the potential of errors. This may be identified through scheduled audits, performance observations, or record review. This position assists in the gathering and compilation of data and information to provide appropriate monitoring of all quality initiatives and programs. The QAS is responsible for ensuring an appropriate investigation of any deviations from process or procedure is complete. The investigation may require root cause analysis and effective corrective or preventative actions. Monitoring for the recurrence or the potential for recurrence is a critical component of data analysis. Essential Functions (ES) and Responsibilities * Key Duties (E) * Assures the Plasma Center(s) is in compliance with all applicable state, federal, and European guidelines. * Has the responsibility to report any deviations (cGMP) or regulatory practices to the Quality Director. * Assures that SOPs, policies, and practices are updated and validated as applicable and that staff is performing in accordance with SOPs through scheduled audits and direct performance observations. * Authorizes the release of final product and has the authority to stop shipment of any product that does not meet compliance or customer specifications. * Assures accurate labeling and documentation of shipments. * Assures center maintains state of readiness for regulatory and customer audits. * Responsible for tracking and trending errors, corrective actions, and the approval of preventative action. * Reports compliance status to necessary parties. * Assures accuracy of electronic donor records in the applicable donor center system. * Assures all supplies and materials meet quality regulations prior to placement into use. * Monitors and ensures the maintenance and calibration of equipment is completed and documented as required by procedures. * Ensures completion and accuracy of training for new employees and competency training of existing staff on an annual basis. * Oversees execution, documentation, and review of internal and external audits. * Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Able to work in high-pressure, deadline-driven environment Basic computer skills including experience with software programs such as Word, Excel, and GroupWise Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Demonstrated ability to work well with people from diverse backgrounds Exceptional organizational and communication skills required Maintains competence with all position required tasks Managing Time Experience Requirements * Education Requirements: * Bachelor's degree or equivalent professional experience. * Experience Requirements: * One minimum of one year of Quality Assurance experience in a Donor Center or similar Quality Assurance or medical field experience. Preferred Experience Compliance Requirements (ES) * As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. * This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. * Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director, Quality Engineering in Boca Raton, FL! Job Title: Associate Director, Quality Engineering : Position Summary The Associate Director, Quality Engineering is responsible for providing leadership and oversight of Quality Engineering functions supporting GMP manufacturing operations. This role ensures that facilities, utilities, equipment, and processes are qualified and validated in compliance with FDA regulations and company policies. The Associate Director will collaborate cross-functionally with Manufacturing, Facilities, Engineering, Validation, and Quality Assurance teams to maintain a state of control, enable continuous improvement, and ensure readiness for regulatory inspections. Essential Functions (ES) and Responsibilities * Lead and manage the Quality Engineering team supporting GMP facility and manufacturing operations. * Serve as SME for validation, equipment qualification, critical utilities, and process validation. * Set strategy and priorities for Quality Engineering activities to support current operations and new product introductions. * Ensure validation and qualification programs (facilities, utilities, equipment, cleaning, process, and computerized systems) meet regulatory expectations and company standards. * Oversee quality review/approval of validation protocols, reports, and change controls. * Partner with Quality Systems to manage deviations, investigations, CAPAs, and change controls related to engineering and validation activities. * Provide guidance during regulatory inspections. * Collaborate with Facilities/Engineering on maintenance and calibration programs for GMP-critical equipment and systems. * Support technology transfers, scale-up, and process validation activities in alignment with lifecycle approaches (e.g., CPV, Stage 1-3 validation). * Drive risk-based decision-making and ensure effective quality risk management practices are in place. * Champion continuous improvement initiatives to optimize compliance, efficiency, and reliability. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Demonstrated ability to use computer software including MicroSoft Outlook, Word and Excel. FDA Adherence Experience Requirements Education and Experience Requirements: * Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred. * 10+ years of experience in Quality, Validation, or Engineering roles in biotech or pharmaceutical GMP manufacturing. * Strong knowledge of FDA and ICH guidance (e.g., ICH Q8-Q10). * Deep expertise in validation lifecycle, equipment/facility qualification, utilities, and process validation. * Experience supporting regulatory inspections with strong knowledge of current industry expectations. * Familiarity with computerized systems validation and data integrity principles (21 CFR Part 11). * Demonstrated leadership and team management experience. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees.To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a full time Plasma Processor. Job Title: Plasma Processor : Position Summary The Plasma Processor is responsible for ensuring the product integrity of the plasma unit and associated samples from the time the unit is collected until the unit is shipped. The plasma processor follows SOPs to collect the appropriate samples from the unit and visually inspects the unit for acceptability. This position has the responsibility of ensuring all products and samples are moved to the appropriate storage units within the proper timeline and ensuring the freezer is organized in a manner that allows for the appropriate segregation of units and quick location of products or samples. Additional responsibilities include packing and staging units for plasma shipments, preparing units and samples for biohazard waste shipments, locating units and samples as requested, and assisting on the donor floor. They are routinely the initial point of contact for deliveries due to the location in the building and must contact the proper individuals to notify them of delivery. Responsibilities on the donor room floor include the set-up of automated collection instruments, monitoring of donors through the collection process, disconnection of donors from the automated instrument, and the management of Level 1 reactions. Responsibilities in the screening area include the capability of interpreting the results of the health history and vital signs in relation to the criteria as outlined in the company procedures and ensuring the acceptability of donors following these established procedures. In addition to completing and maintaining the qualification of a plasma processor, cross-training and successful qualification for donor tech and donor screener functions is a standard expectation of the role. The plasma processor must maintain clean efficient work environment, and ensure sufficient operating supplies and forms are available as needed. Follows all FDA and OSHA policies and procedures and maintains confidentiality of all personnel, donor and center information. They also assist with the administrative duties to support the Donor Center and maintain compliance with procedures and regulations while following the current Good Manufacturing Practices (cGMPs). Essential Functions (ES) and Responsibilities Key Duties (E): o Labels and verifies sample tubes, unit label number, and sample tube label number prior to sampling. o Collects all required samples from the unit following ADMA SOP's to ensure that sterility is maintained. o Places units and samples in freezer within 30 minutes of collection. o Completes the entire processing of only one (1) at a time to prevent unit mix ups. o Stores units and samples in accordance with SOPs. o Accurately and efficiently completes all unit, sample packing, and shipping functions. o Physically arranges cases and samples in the freezer to ensure it always remains organized for ease of retrieval of both units and samples. o Perform quality control of areas area equipment. o Obtain any back up samples as required for the laboratory or customers. o Sets-up and readies the collection device correctly. Essential Functions (E) and Responsibilities Collects and labels the required samples at the donor bedside. o Inspects soft goods prior to use to confirm there is no breakage, kinks in the line, contamination, or particles in the solutions. o Correctly maintains, handles, and cleans equipment in accordance with manufacturer's recommendations. o Operates the automated collection device as determined in the user manual. o Monitors the donor for any sign of reaction before, during, and after plasmapheresis. o Disconnects the donor from the automated collection device and ensures the donor is in good physical condition prior to release. o Records information in the collection device as prompted. Records medical incidents as applicable. Records equipment incident information as prompted. o Restocks supplies as necessary. o Reports all unsafe situations or conditions to immediate supervisor or member of center management immediately. o Confirms donor identification in Screening. o Teaches the donor to use the self-administered questionnaire and assist as needed. o Performs donor arm checks. o Determines donor vital signs and weight and properly records results in applicable donor center system. o Determines donor suitability by reviewing donor responses to questionnaire and confirming the donor has provided the correct answers to donor suitability questions. o Defer donors based on knowledge of donor acceptance and deferral criteria. o Explains deferrals and associated time frames to donors. o Respects and maintains donor confidentiality regarding donor deferrals. o Performs donor total protein readings using a refractometer and records the results in n applicable donor center system. o Performs donor hematocrit readings and records the results in applicable donor center system. o Enters required information into the applicable donor center system. o Confirms all required donor suitability criteria and associated records are complete and accurate before determining donor acceptance. o Maintains an organized and clean work environment. o Maintains competence with all position required tasks. o Attends scheduled staff training and staff meetings. o Additional duties as related to/supporting the needs of the business can be assigned by management as deemed necessary. o Perform the function of donor floor technician and other positions based on the needs of the business and at the discretion of leadership. Job Responsibilities or Job Requirements Competencies Demonstrated ability to work well with people from diverse backgrounds Basic computer skills Maintains a professional appearance and demeanor when interacting with peers and donors Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Managing Time Able to work in high-pressure, deadline-driven environment Experience Requirements * Education Requirements: High school diploma or equivalent required. * Experience Requirements: None Preferred Experience Compliance Requirements (ES) o Executes donor reviews in accordance with SOPs. o Follows all FDA and OSHA policies and procedures and maintains confidentiality of all personnel, donor, and center information. o Performs work duties with strict adherence to procedures and regulations. o Performs job duties and maintains records in accordance with cGMP requirements. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year). To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Executive Operations Coordinator in Boca Raton, FL! Job Title: Executive Operations Coordinator : Position Summary The Executive Operations Coordinator supports the executive as assigned. Provides key administrative functions that enable the executive to operate at peak efficiency. Coordinates email correspondence, travel arrangements, minutes of meetings, assembly of materials for presentations and manages the executives' calendar. Will analyze and prepare data and reports. Maintains complete confidentiality at all times. Essential Functions (ES) and Responsibilities * Compose original correspondence, documents, reports, and presentations as directed; edit for clarity; proofread for accuracy and appearance; copy, mail, scan, fax and/or overnight mail as needed. * Maintain appointment calendar; coordinate, schedules, arrange meetings and conferences on behalf of the Executive. Meeting arrangements may include reserving meeting space, hotel rooms, arranging meals or refreshments, and audio/visual equipment, etc. * Support high-level executives in their daily tasks. Represent the executive office in a pleasant and professional manner at all times. * Act as liaison by maintaining open communication. Answer all telephone calls internal and external, as well as screen telephone calls; redirect calls as needed; take messages. Relay urgent or sensitive calls; follow-up to ensure proper response. * Types and designs general correspondence, memos, charts, tables, graphs, business plans, PowerPoint presentations, publishing documents etc. Proofread documents for spelling, grammar and layout and make necessary changes. Responsible for accuracy and clarity of final documents. * Works independently and with a team on projects. Acts as project manager for special projects which may include planning, scheduling, coordinating presentations and information, creating specialized reports, and disseminating information, materials and meeting minutes. * Always maintain complete confidentiality. * Exercises sound judgment in addressing and proactively manager daily business issues with minimal direction. * Maintains an orderly, logical filing system and a digital filing system of business licenses, contracts, SOWs, and any other documentation to facilitate prompt retrieval of documents. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Experience Requirements Experience Requirements: Requires five or more years of successful administrative experience, including at least three years at the senior executive level; preferably in a mid to large public corporation. Requires professional experience in working with senior-level executives within and outside the company, as well as customers, vendors, visitors, and others. Education Requirements: Bachelor's degree required. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-Rail - Free shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* * ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Scientist, Production Operations in Boca Raton, FL! Job Title: Senior Scientist, Production Operations : Position Summary The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Thie role will drive and/or coordinate process improvements, utilizing the quality system as required. Generate and analyze trend reports on production processes (both in-process and FIN) as needed and track effectiveness of changes. Support a strong cGMP environment. Essential Functions (ES) and Responsibilities * Develop subject matter expertise in biologic protein fractionation, purification, and fill finish technologies to support Production Operations. * Technical lead for all departmental projects, change controls, risk assessments, deviations, CAPAs, and audit support. * As needed provide data/analysis to support groups including: MQA, PD, Regulatory Affairs, Microbiology, Engineering and Validation. * Utilize project management skills to track progress of projects to ensure milestones are met. * Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set and communicate status on a routine basis. * As needed analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control. * Support the development of training strategies and materials for manufacturing and support teams as needed. * Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required. * Partner with support functions to continuously improve safety and quality to meet ADMA goals. * Stay current on industry trends. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail FDA Adherence Strong organizational, interpersonal and collaborative skills Experience Requirements Education Requirements: Bachelor's degree in science, engineering, or another related technical field preferred Experience Requirements: * 10+ years of experience in Plasma Fractionation or Purification or Fill Finish Operations * Experience in all aspects of Manufacturing preferred * Knowledge of world-class manufacturing methods (QLP, Lean, Six Sigma), DMAIC, Good Manufacturing Practices, Food and Drug Administration regulations * Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels. * Must be able to work and facilitate a team-orientated environment. * Must have demonstrated project management skills and/or project delivery skills. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, SOPs, in their area of work and responsibility. This includes ensuring all Quality Assurance(QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner, Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* * ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Screening and Registration Supervisor. Job Title: Supervisor, Screening & Registration : Position Summary The Screening and Registration Supervisor will supervise the day-to-day activities of both the registration and screening areas. The Screening and Registration Supervisor will oversee the execution of the training plan and SOPs for all employees who work in these areas. This individual will work to ensure an environment of teamwork and mutual respect between staff members. This position will manage donor flow to ensure donor satisfaction and center production is maximized with the intent of providing a safe, healthy, and friendly environment for both donor and staff. Continuous observation of staff to ensure compliance with SOP's and regulatory requirements. Any identified deviations in these areas must be immediately addressed to lessen the likelihood of repeated infractions and elevated to the next level of management as deemed necessary. The supervisor is responsible for ensuring that all activities under their oversight and the staff reporting to them are always prepared for audit. This includes organization of area, staff training to include complete and accurate records, and staff execution of all activities. Providing a high level of customer service is a critical responsibility of this position. This position is not intended as an administrative position but provides a bridge between daily operations functions and administration. Essential Functions (ES) and Responsibilities * Key Duties (ES): * Monitors donor flow to ensure donors are moving through the center at the expected pace, adjusting as necessary, and seeking ways to improve workflow and identify efficiencies. * Works directly with QAS/designee in areas such as monitoring of errors, developing and implementing corrective actions, and ensuring the Center meets regulatory, cGMP, and customer requirements always. * Ensures medical supplies and other company resources are used as intended by routinely monitoring inventory against usage. * Ensures trained and adequate staff are available daily. * Directly oversees donor satisfaction on a day-to-day basis and works to limit all unnecessary annoyances or delays. * Provides input into annual evaluations. * Sets an example of good work ethic and instills good work ethic in staff. * Other duties as assigned by management. * Supervisory Duties: * Monitors staff performance against existing standards and provides immediate correction to staff as needed. * Manages absences, attendance issues, and work task schedules on a proactive basis. * Provides routine feedback to supervisor through one-on-one communication, telephone updates, action reports and other management reports. Informs supervisor of critical issues right away. Job Responsibilities or Job Requirements Competencies Experience Requirements * Education Requirements: * High School diploma * Experience Requirements: * Previous experience in a supervisor role in a medical related field preferred. * Ability to drive for extended periods (four hours at a time). * Ability to drive or fly to company/industry meetings, training, and in support of other ADMA Centers as determined by supervisor. * Occupational Exposure to blood borne pathogens. * Available to work extended shifts and weekends. * Ability to lift, pull, or tug up to 40lbs. * Work requires extended periods of standing and bending. * Ability and skill level to supervise and train others required. Preferred Experience Compliance Requirements (ES) * Ensures staff reporting to them are trained and competent in accordance with the SOP's, regulatory requirements, center training plan, and available to support safe and efficient donation activity. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Donor Screener. Job Title: Donor Screener : The Screener is responsible for ensuring the acceptability of donors following established procedures. The Screener must be capable of interpreting the results of the health history and vital signs in relation to the criteria as outlined in the company procedures. Responsibilities on the donor room floor include the set-up of automated collection instruments, monitoring of donors through the collection process, disconnection of donors from the automated instrument, and the management of Level 1 reactions. The Screener also assists with the administrative duties to support the Donor Center and maintains compliance with procedures and regulations while following the current Good Manufacturing Practices. The Screener is a representative of our organization and interacts directly with the donors. The Screener is always expected to be professional and courteous. Essential Functions (ES) and Responsibilities * Confirms donor identification. * Teaches the donor to use the self-administered questionnaire and assist as needed. * Performs donor arm checks. * Determines donor vital signs and weight and properly records results in applicable donor center system. * Determines donor suitability by reviewing donor responses to questionnaire and confirming the donor has provided the correct answers to donor suitability questions. * Defer donors based on knowledge of donor acceptance and deferral criteria. * Explains deferrals and associated time frames to donors. * Respects and maintains donor confidentiality regarding donor deferrals. * Performs donor total protein readings using a refractometer and records the results in n applicable donor center system. * Performs donor hematocrit readings and records the results in applicable donor center system. * Performs quality control of screening equipment. * Enters required information into the applicable donor center system. * Confirms all required donor suitability criteria and associated records are complete and accurate before determining donor acceptance. Job Responsibilities or Job Requirements Competencies Ability to understand and interpret government regulations and customer specifications Able to work in high-pressure, deadline-driven environment Computer proficient with intermediate skills in office programs Experience Requirements * High school diploma or equivalent required. Preferred Experience Compliance Requirements (ES) * Executes donor reviews in accordance with SOPs. * Performs work duties with strict adherence to procedures and regulations. * Performs job duties and maintains records in accordance with cGMP requirements. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Technician, Industrial Maintenance - Night in Boca Raton, FL! Job Title: Senior Technician, Industrial Maintenance : Position Summary This position has the responsibility to ensure the proper operation and maintenance of all facility systems and equipment. They will take corrective action and repair equipment when necessary. Provides appropriate notification and documentation of all work performed. Daily activities may include performing mechanical and/or electrical troubleshooting and tasks, PM activities, and other tasks involving various operations and repairs within a cGMP manufacturing facility. This is a night shift position (7PM-7AM). Essential Functions (ES) and Responsibilities * Responds to emergencies as requested utilizing resources to effectively repair and ensure the safety and availability of ADMA systems and equipment. * On non-supervised shifts, the individual is responsible for the continued operations of the facility, plant, and production systems. This employee has the authorization in the absence of written procedures or instructions to start and stop equipment to ensure continued operation until necessary corrective action can be taken and if necessary, call in additional off-duty personnel to assist in problem resolution. * Responsible for the proper operation and maintenance of all facility systems. This includes, but is not limited to the following: routine preventative maintenance; corrective maintenance and document related work performed, materials, parts and supplies used in work order documentation for systems like Water for Injection (WFI) systems, autoclaves, HVAC systems, steam systems, high capacity chillers, ultra-low temperature refrigeration systems, cooling towers, liquid pumping and compressible gas fluid systems including air compressors, nitrogen, natural gas, diesel fired boilers, clean steam, waste water systems etc. * Performs the job function in compliance with safety, health, environmental, and governmental regulations and in compliance with ADMA SOPs for facility operations. * Research codes and existing ADMA procedures for conformance to regulatory codes. * Insure outside venders and contractors are trained in applicable ADMA procedures regarding safety, environmental, and health. They must also be monitored to comply with all ordinances such as electrical and construction codes. * Assist the Instrumentation Technician II in the calibration and repair of devices within the manufacturing facility. * Assist facility management in the training and the development of skills for Facility Operations I & II. * Ensure plant is clean and free of debris or clutter. * Will assist in special projects and/or construction projects. Duties may include demolition, renovation, and new construction. Job Responsibilities or Job Requirements Competencies Ability to read and understand blueprints Able to work in high-pressure, deadline-driven environment Good mechanical aptitude and knowledge of general maintenance. Experience Requirements Education Requirements: High school diploma or equivalent plus four (4) years of technical or vocational training. Equivalent experience may be substituted for technical/vocational experience. Experience Requirements: Six years + previous maintenance in a manufacturing environment and/or construction experience. cGMPs and ISO regulatory knowledge needed for this position. Preferred Experience Preferred Education Requirements: Florida Professional License preferred. Preferred Experience: Six years' experience in the pharmaceutical/medical devices industry preferred. Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Reliability Engineer! Job Title: Reliability Engineer : Position Summary The Reliability Engineer will provide maintenance reliability and predictive maintenance support to the Manufacturing Facility and develop/establish the reliability engineering tools/programs to ensure that all equipment remain in optimal state of operation and cGMP compliance. Must have the ability to apply engineering theory, practices, and principles to determine root cause of equipment failures and to perform equipment performance evaluations. Essential Functions (ES) and Responsibilities * Works to ensure the reliability and maintainability of new and modified installations. The Reliability Engineer is responsible for adhering to the Life Cycle Asset Management (LCAM) process throughout the entire life cycle of new and existing assets. * Participate in the development of design and installation specifications along with commissioning plans. Participate in the development of criteria for and evaluation of equipment and technical MRO suppliers and technical maintenance service providers. Develops acceptance tests and inspection criteria. * Participates in the final check out of new installations. This includes factory and site acceptance testing that will assure adherence to functional specifications. * Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems. * Professionally and systematically defines, designs, develops, monitors, and refines an Asset Maintenance Plan that includes Value-added preventive maintenance tasks and Effective utilization of predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems * Provides input to a Risk Management Plan that will anticipate reliability-related, and non-reliability-related risks that could adversely impact plant operation. * Works with Production to perform analyses of assets including Asset Utilization, Overall Equipment Effectiveness, remaining useful life and other parameters that define operating condition, reliability, and costs of assets. * Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations. These problems include capacity, quality, cost, or regulatory compliance issues. To fulfill this responsibility the Reliability Engineer applies: * Data analysis techniques that can include: * Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Analysis, Six Sigma (6σ) Methodology * Root-cause, Root-Cause Failure and Failure Mode Effectiveness Analysis (RCA, RCFA, FMEA) * Failure Reporting, Analysis and Corrective Action System (FRACAS) * Preliminary Hazards Analysis (PHA) Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Ability to read and understand blueprints Ability to understand and interpret government regulations and customer specifications Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures Able to work in high-pressure, deadline-driven environment Actively provides feedback to operations management and staff regarding staff performance against SOPs. Works to develop and maintain a collaborative and effective working relationship with operations management Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project) Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines FDA Adherence Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs Knowledge of instruments and electronics would be helpful to assist in the calibration and repair of control devices Must be able to prepare, deliver spreadsheets, data analysis, presentations and facilitate for small and large groups Possess time management skills and be able to balance multiple job assignments at once Experience Requirements Education Requirements: Bachelor's degree in mechanical engineering or equivalent. Experience Requirements: Minimum of 5 years of reliability engineering/maintenance experience in a cGMP, Pharmaceutical/Biological manufacturing environment. Experience with process equipment (e.g., pumps, centrifuges, refrigeration, fluid flow). Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* * ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: Job Title: Phlebotomist : This position is responsible for ensuring the safety of donors and purity of product as a result of the plasma collection process. They monitor the donor throughout the collection process for equipment errors, donor reactions, or any unexpected events taking the appropriate actions when any unexpected event occurs. Must be capable of interpreting the results of the health history and vital signs in relation to the criteria as outlined in the company procedures. Responsibilities on the donor room floor include the set-up of automated collection instruments, monitoring of donors through the collection process, disconnection of donors from the automated instrument, and the management of Level 1 reactions. Ensures the product integrity of the plasma unit and associated samples. Ensures products are dispositioned and has the responsibility of collecting appropriate samples while ensuring product is frozen and stored in accordance with ADMA procedures. Stages units for shipment and samples for testing. Physically arranges samples and cases in freezer to ensure organization. The phlebotomist is a representative of our organization interacting continuously with donors so must at all times be professional, courteous, and attentive to service provided to all donors at the site. Teamwork, respect, and courtesy is required with your coworkers at all times. Takes initiative to elevate work related skills with the goal of obtaining the Advanced Phlebotomist position. In addition to completing and maintaining the qualification of a phlebotomist, cross-training and successful qualification for plasma processing and donor screener functions is a standard expectation of the role. Essential Functions (ES) and Responsibilities * Identifies donors in accordance with SOPs. * Greets donor in a courteous and professional manner. * Sets up and readies the collection device appropriately. * Performs arm scrub correctly to ensure donor safety and product purity. * Verifies the label set printed clearly, is legible, and the alignment is correct. * Labels the collection bottle as defined in ADMA SOP's. * Collects and labels required samples at the donor bedside. * Inspects the soft goods prior to use to confirm there is no breakage, kinks in the line, or contamination or particles in the anticoagulant or saline. * Performs quality control of area equipment. * Operates the automated collection equipment in accordance with ADMA SOP's and manufacturer's instructions. Job Responsibilities or Job Requirements Competencies Ability to understand and interpret government regulations and customer specifications Able to work in high-pressure, deadline-driven environment Computer proficient with intermediate skills in office programs Experience Requirements * Physically arranges cases and samples in the freezer to ensure it always remains organized for ease of retrieval of both units and samples. * Perform quality control of equipment used in the processing and packing areas. * Obtain any back up samples as required for the laboratory or customers. * Must maintain the confidentiality of all personnel, donor, and center information. * The phlebotomist is required to assist with the administrative duties to support Donor Center initiatives as assigned. * Attends scheduled staff training and staff meetings. * Additional duties as related to/supporting the needs of the business can be assigned by management as deemed necessary. * Monitors donors for any signs of reaction before, during and after plasmapheresis. * Accurately documents collection issues in the applicable center system and in accordance with center SOP. Note that the system used in the center may be a manual system. * Disconnects the donor from automated collection equipment and ensures donor is in good physical condition prior to release. * Completes all documentation requirements accurately and as required for the machine and donation software system. * Reports all unsafe situations or conditions to immediate supervisor. Preferred Experience * Previous experience as a phlebotomist in a blood or plasma collection center preferred. * Minimum of 12 months in the health field preferred or a combination of experience and education equivalent to this requirement. Compliance Requirements (ES) * Strictly adheres to all cGMPs, ADMA SOP's and appropriate regulations. * Annual GMP training. * Maintains an organized and clean work environment ensuring splatters, spills, and the floor are cleaned appropriately before moving to the next task. * Ensure enough supplies are available as needed. * Disinfects the bed thoroughly between each donor. * Teaches the donor to use the self-administered questionnaire and assist as needed. * Performs donor arm checks. * Determines donor vital signs and weight and properly records results in applicable donor center system. * Determines donor suitability by reviewing donor responses to questionnaire and confirming the donor has provided the correct answers to donor suitability questions. * Defer donors based on knowledge of donor acceptance and deferral criteria. * Explains deferrals and associated time frames to donors. Job Description Footer: Apply now

The Physician Substitute Manager is part of the site leadership team, promoting company culture and enforcing company standards and expectations, within all areas of the center. This position is directly responsible for providing supervision to all Physician Substitutes within the plasma collection center. These responsibilities include, but are not limited to, operational efficiency, regulatory compliance, performance evaluations, time and attendance oversight, and corrective actions, as necessary. The Physician Substitute Manager must ensure competency of all medical staff and enforce Physician Substitute adherence to Standard Operating Procedures (SOPs), FDA guidance, and regulations when determining the acceptability of donors. Soliciting guidance of the Medical Director and/or Center Licensed Physician(s) when necessary. This position also oversees the reviews of normal donor laboratory test and the proper management of abnormal test results, to ensure all staff are compliant with the regulatory and ADMA procedural requirements. The Physician Substitute Manager reports directly to the Center Director for day-to-day management and leadership. They may collaborate with the Medical Director or Licensed Center Physician(s) while making any decisions which directly impact donor suitability. This position must ensure the appropriate medical oversight in screening, phlebotomy, and the plasma processing areas. It is required to work in the production areas of the Donor Center 85% of the time to facilitate identification of production, staffing, quality, and personnel issues. Job Description Footer: Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Physician Substitute. Job Title: Physician Substitute, Licensed Practical Nurse : Position Summary Under the direction of the Medical Director and/or Center Licensed Physician(s), the Physician Substitute determines the acceptability of all first-time donors and return applicant donors. The Physician Substitute determines the suitability of donors by following Standard Operating Procedures (SOPs) designed to ensure the donor meets suitability criteria in accordance with FDA guidance and regulations. The Physician Substitute also reviews normal donor laboratory test and refers abnormal test to the Physician for review. The Physician Substitute works closely with the Medical Director or Licensed Center Physician(s) while making any decisions which directly impact donor suitability. The Physician Substitute also provides medical oversight in screening, phlebotomy, and the plasma processing areas. Essential Functions (ES) and Responsibilities Key Duties (ES): * Performs new and returning donor physicals, and annual donor physicals. The Physician Substitute may not perform physical examinations for donors receiving red blood cell immunizations. * Administers and answers donor questions about the Plasmapheresis Informed Consent, RSV Plasmapheresis Informed Consent and the informed consent for any other applicable donation program. * Administers the AIDS Bulletin and assesses the donors understanding of high-risk activities. * Keeps accurate, legible, and complete donor records in accordance with cGMP. * Reviews normal donor laboratory work within time requirements as outlines in the SOPs and refers abnormal lab work to the Licensed Center Physician(s). * Observes and approves staff training in medically related areas. * Ensures donor reviews are executed in accordance with SOPs. * Provides immediate care and assessment of all donor reactions. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Able to work in high-pressure, deadline-driven environment Basic computer skills including experience with software programs such as Word, Excel, and GroupWise Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Demonstrated ability to work well with people from diverse backgrounds Maintains a professional appearance and demeanor when interacting with peers and donors Experience Requirements * Education Requirements: High school diploma or equivalent required. * Experience Requirements: None. * Certification(s): CPR certified or the ability to obtain certification. * License(s): Current RN, LPN, or Advanced EMT license in the state the Donor Center operates. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. * Job Limitations: The Physician Substitute may not: * Prescribe immunization orders or evaluate the clinical response to donor immunizations. * Authorize Donor Center staff to administer drugs from the emergency kit. * Fulfill the Licensed Physician's responsibilities for: * Therapeutic Exchange Plasma * RBC Immunization * Plasmapheresis of HBsAg reactive Donors * Plasmapheresis of HIV antibody positive Donors * Disease State Donor Programs * Review abnormal lab results. * Re-instate Donors who have been deferred due to an abnormal Serum Protein Electrophoresis (SPE). Licensed Center Physician approval is required for the reinstatements of deferred donors. Physician Substitute may only review steps with Licensed Center Physician to re-establish suitability of a Donor. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Job Title: Associate, Regulatory Affairs : Position Summary Responsible for coordinating and executing ADMA Biologics lookback program. Coordinate communications between State, CLIA, and COLA programs with Center Management. Contribute to compliance with FDA's requirements for Biological Product Deviation Reporting. Essential Functions (ES) and Responsibilities * Provide guidance to Plasma Centers regarding compliance with FDA regulations/guidance and applicable international requirements. Coordinate communications necessary to complete government-mandated tasks (e.g., lookbacks, Biological Product Deviation Reports) between Center Managers, other departments, customers, and regulators to facilitate information sharing and resolve problems. * Responsible for timely and accurate processing and coordination of ADMA Biologics lookbacks consistent with regulatory requirements and customer specifications. Research discrepant/ missing information and analyze final reports for accuracy to provide accurate and timely information to customers. * Serve as ADMA Biologics' primary contact regarding CLIA and COLA programs. Provide guidance and assist in responses to audits and inspections. * Evaluate Post Donation (PDI) and Error/Accident Reports (EAR) to determine if they meet the threshold of Biological Product Deviation Reports (BPDR) for reporting to the FDA. Prepare and submit BPDRs to the FDA. Maintain statistical data relating to EARs/PDIs/BPDRs. * Evaluate Plasma Center freezer temperature exposure incidents to determine plasma relabeling and reporting to customers. Generate resolution letters for Plasma Center records. * Assist with investigations related to DMS change requests, including donor number errors and test hold removals. * Track incoming/outgoing paperwork to ensure FIFO processing; determine what information should be retained versus what should be discarded and prioritize processing. * Update departmental SOPs as required. * Filing, faxing, copying, and mailing of paperwork and reports. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Ability to understand and interpret government regulations and customer specifications Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures Able to work in high-pressure, deadline-driven environment Experience Requirements * A minimum of 2 years of experience in Plasma or related field or FDA regulated industry with some laboratory and cGMP experience. Education Requirements: * Bachelor's Degree required. Degree can be offset by equivalent experience. Preferred Experience * Some general office experience helpful, typing and customer service; experience in plasma center operations preferred. Compliance Requirements (ES) The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Chemist I in Boca Raton, Florida! Job Title: Chemist I : Position Summary The Chemist I will perform quality control testing of raw materials, in-process and final products; following general instructions on routine work and detailed instructions on new assignments. Essential Functions (ES) and Responsibilities * Perform quality control chemistry and/or Immunoassays for raw materials, in-process and final products according to approved Standard Operating Procedures (SOPs). * Perform instrument calibration or qualification according to written procedures. * Perform testing as needed to generate data for method validations and other special projects, following general instructions on routine work and detailed instructions on new assignments. * Fulfill requests from management for assistance in other matters as needed. * Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines. * Utilize cGMP practices in documentation and execution of job functions. * Review documentation on trained tasks as assigned by manager. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Able to work in high-pressure, deadline-driven environment Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Possess time management skills and be able to balance multiple job assignments at once Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations Experience Requirements Education Requirements: B.S. in Chemistry, Biochemistry, Molecular Biology or related science discipline is required. Experience Requirements: This position requires experience in a laboratory setting. Work experience in a regulated environment (FDA, EPA, etc.) is preferred. Preferred Experience Compliance Requirements (ES) The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-Rail * Free shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Technician, Industrial HVAC in Boca Raton, FL! Job Title: Technician, Industrial HVAC : Position Summary This position has the responsibility to ensure the proper operation and maintenance of all facility HVAC systems and equipment. Take corrective action and repair equipment, as necessary. Provide appropriate notification and documentation of all work performed. Daily activities will include performing HVAC PMs, troubleshooting systems, mechanical and electrical repairs related to HVAC systems and other tasks involving various operations and repairs within a cGMP manufacturing facility. Essential Functions (ES) and Responsibilities * Responsible for the proper operation and maintenance of all facility HVAC systems, high-capacity chillers, ultra-low refrigeration systems, cooling towers, and liquid pumping systems. * Responds to emergencies as requested utilizing resources to effectively repair and ensure the safety and availability of ADMA systems and equipment. * Ability to maintain, troubleshoot, and repair package units including large tonnage systems. * Ability to maintain, troubleshoot, and repair split systems including large split systems, built up systems, water source heat pump equipment. * Ability to maintain, program, troubleshoot, and repair commercial chiller cooling systems and chilled water pumps. * Ability to maintain, program, troubleshoot, and repair VFDs in various applications. * Ability to trace out and troubleshoot complex electrical systems. * Ability to maintain, troubleshoot, and repair specialized systems such as Daikin, Vilter, and Dunham Bush screw compressor systems. * Ability to maintain, troubleshoot, install cooling tower motors, fans, and pumps. * Perform complex troubleshooting and repair of HVAC systems ensuring the facility stays within a cGMP state. * Provide technical assistance for investigations when equipment or system failure occurs. * Oversee technical repairs performed by outside contractors on HVAC or related equipment. * Research codes and existing ADMA procedures for conformance to regulatory codes. * Ensure outside vendors and contractors are trained in applicable ADMA procedures regarding safety, environmental, and health. They must also be monitored to comply with all ordinances such as HVAC and construction codes. * Ensure the plant is clean and free of debris or clutter. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Ability to read and understand blueprints Experience Requirements Education Requirements: High school diploma or equivalent is required. A minimum of two years of technical or vocational training is required. Equivalent experience (two years HVAC work) may be substituted for technical/vocational experience. Experience Requirements: 10 years of previous HVAC work in a manufacturing or commercial environment is required. Working knowledge of local, state, and other HVAC codes is required. Preferred Experience Experience with BMS (Building Management Systems) is preferred. Demonstrated experience/proficiency/knowledge/training in a regulated cGMP (FDA, EPA, etc.), manufacturing, or pharmaceuticals environment preferred. Basic knowledge of HVAC system installation, operational techniques and safety compliance, instrumentation, and controls, and building automation systems. Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* * ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Project Engineer in Boca Raton, FL! Job Title: Senior Project Engineer : Position Summary The general purpose of the Senior Project Engineer is to provide engineering, project management, manufacturing and maintenance support to the GMP manufacturing site. Ability to troubleshoot, problem solve and implement engineering solutions for existing manufacturing processes and equipment. Direct, evaluate and assist capital engineering and process improvement projects. Design, procure and commission new process and utility equipment and upgrades to existing systems. Essential Functions (ES) and Responsibilities * Managing mid-to-large sized engineering projects by planning and tracking activities of cross-functional teams and contractors. Develop schedules and performance requirements using appropriate verification tools and techniques to manage project scope, schedule and cost ensuring that project goals are met on time and within budget. Analyze resources and priorities to be applied to assigned projects and perform risk management activities to minimize project risks. * Develop and execute commissioning plans to ensure that process and utility systems and equipment are suitable for their intended use * Develop and review process flow diagrams and piping and instrumentation drawings (P&IDs) for new process and utility systems and modifications to existing systems * Direct and or assist in the design and execution of all capital projects assigned. * Support engineering development with load calculations of flow, heating/cooling capacity, pressures, etc. * Utilize strong technical writing skills to prepare engineering evaluations, change control documentation, testing plans, corrective and preventive actions (CAPAs) * Lead and assist in investigations of process systems and equipment to determine and document root cause and ensure the appropriate corrective actions are initiated and implemented. Use statistical tools in analyzing data to predict trends, measure process capability, improve operating procedures or preventative maintenance procedures, identify bottle necks and equipment reliability. * Help develop efficient PM plans for all key pieces of manufacturing and utilities equipment and provide troubleshooting expertise in all areas of plan operations and maintenance. * Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance/facility aspects of the manufacturing facility * Assist in writing regulatory documents for FDA submissions as required. * Create capital expenditure requests and purchase requisitions for approvals prior to procurement of process and utility systems and equipment Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Ability to read and understand blueprints Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures Able to work in high-pressure, deadline-driven environment Actively provides feedback to operations management and staff regarding staff performance against SOPs. Works to develop and maintain a collaborative and effective working relationship with operations management Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project) Excellent problem-solving and analytical skills and be able to frame issues clearly for less technical colleagues and customers Exceptional organizational and communication skills required Good mechanical aptitude and knowledge of general maintenance Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs Must have excellent writing and oral skills Outstanding interpersonal, verbal, and written communication skills - must be able to translate technical concepts into non-technical terms for both senior level management and frontline staff Possess time management skills and be able to balance multiple job assignments at once Experience Requirements * Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* * ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Business Systems Analyst- FICO in Boca Raton, FL! Job Title: Business Systems Analyst - FICO : Position Summary The Business Systems Analyst is responsible for performing a variety of business system support activities at the Boca Raton facility. Essential Functions (ES) and Responsibilities * Function as a technical resource to facilitate the various stages of the data solutions life cycle including Investigation, Analysis, Design, Testing, Installation, Maintenance and Training. * Function as subject matter expert of applications, including third-party applications, that interface with SAP such as Blackline, Vertex, Concur, and SAP Analytics Cloud (SAC). * Function as subject matter expert of internal SAP FICO business processes. * SAP S4HANA Finance experience in General Ledger, Accounts Receivable, Accounts Payable, Bank and New Asset Accounting. * SAP S4HANA experience in SAP Controlling: Cost center, Product costing, Material ledger and Actual Costing. * Work as a liaison between IT, SAP AMS vendor and local departments supporting SAP FICO module. * Design, configure, deliver processes in SAP FICO and work with the business on problem areas and propose solution. * Manage issue resolution, interaction with internal and external resources, outside vendors, independent research and investigation. * Support end users and business owners by answering questions, service desk ticket requests and troubleshooting potential problems. * Lead opportunities that drive modernization using new SAP technology, tools, features, and functions. * Investigate existing data solutions for opportunities to improve business processes and participate with management in the investigation of new technologies. * Test developed solutions to ensure accurate compliance with project goals and established procedures, and document the results for management review. * Design and create test scripts, perform unit testing, and support business owner user acceptance testing of system enhancements. * Assist in our internal change management process and SAP minor enhancement requests by working closely with the Functional, Development, Infrastructure, BASIS and Security teams, to deliver high quality solutions on time. * Review and revise SOPs with emphasis on compliance and continuous improvement. * Assist with internal/external audit requests to meet SOX compliance. * Create, review, and update SAP system related policies, procedures, templates, and forms. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Ability to understand and interpret government regulations and customer specifications Able to work in high-pressure, deadline-driven environment Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project) Excellent problem-solving and analytical skills and be able to frame issues clearly for less technical colleagues and customers Exceptional organizational and communication skills required Must have thorough knowledge of Oracle, SQL, and Jaspersoft studios SAP Security Knowledge Experience Requirements * Information Technology or related field experience required. * 3-5 years' experience in application support. * 3-5 years' experience with SAP S4HANA, ECC in a GAMP 5, cGMP, and SOX-regulated, public stock company, via in house IT Department. * Experience with supporting various SAP FICO Module. * Understanding of SAP best practices and usage of FIORI apps, embedded analytics. Preferred Experience Information Technology or related field. Preferred Education Requirements: Bachelor's degree in Computer Science or related field. Compliance Requirements (ES) The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Center Training Coordinator in Myrtle Beach, South Carolina! Job Title: Center Training Coordinator : Position Summary The Center Training Coordinator position is to ensure the competency and continued development of center staff, including management. This position is responsible for the execution and ongoing monitoring of center training programs. The role involves facilitating instruction, scheduling, and coordinating training to align with business objectives and needs. Additionally, this role provides information and feedback necessary for analyzing center training needs and supports the development of Preceptors nominated for center training support. Furthermore, this role utilizes the Learning Management System (LMS) / eQMS to track staff progress through the training process, ensuring competency and completion. Essential Functions (ES) and Responsibilities * Executes and provides support for all ADMA BioCenter training initiatives. * Ensures center personnel complete the required training for their job function in a timely manner and demonstrates competency upon completion. * Performs observations and checks in with new hires during the training process to ensure they are progressing as expected and work with center management and training leadership to make corrections as necessary. * Conducts new hire orientation and onboarding activities. * Report analysis findings and learning resource needs to -Training leadership when identified. * Provides feedback to assist in selection of center preceptors. * Support the training and development of Training Preceptors at plasma center locations. * Ensures an active cross training program is established and maintained. * Maintains working knowledge of LMS /eQMS and assigns or ensures training is assigned to staff as needed. * Collaborates with training leadership & Instructional Designer to develop training plans related to CAPAs where training or additional development is documented as part of the CAPA response. * Assists with updates to training materials when revisions are required. * Participate in the continuous evaluation and improvement of training programs, training materials, and learning profiles for the business. * Maintains competency in all center functions. * Runs regularly training reports from the LMS / eQMS and advises leadership and staff of any training pending. * Required to continuously work in production areas to assist with training and remain current on skillsets. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detail Ability to train and motivate employees at all levels within an organization Knowledge of all Federal and State regulations including OSHA and CUA Able to work in high-pressure, deadline-driven environment Experience Requirements * A minimum of 1 year of working in a plasma center with responsible roles, which may include training or working as a preceptor for at least 1 year and or working in a clinical setting for at least 1 year. Preferred Experience * 1-2 years of Phlebotomy experience. Compliance Requirements (ES) The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations. Other Essential Knowledge: * Experience planning, organizing, and coordinating resources. * Strong organizational skills. * Strong written and verbal communication, interpersonal and presentation skills required to drive results and deliver relevant information to the business. * Ability to travel by car and/ or air as needed. * Intermediate knowledge of Microsoft Office products. * Ability to work with media to conduct video and other presentations. * Knowledge of traditional and modern training methods and techniques. * May work in temperatures of colder than -30C for short periods of time. * Potential exposure to Blood-Borne Pathogens. * * Maintain all training related paperwork, including but not limited to accurate documentation and storage of applicable records. * Supports any audits from a training perspective. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Field Reimbursement Manager - Northeast and Mid-Atlantic Regions! Job Title: Field Reimbursement Manager Market Access - Northeast & Mid-Atlantic Regions : Position Summary The Market Access Field Reimbursement Manager (FRM) (Northeast & Mid-Atlantic Regions) will proactively engage with the ADMA Biologics field force to provide education and support to provider, their offices, and support staff on ADMA HUB Patient Support Program and services, national and regional payor coverage, policy, and criteria. This role serves as the key contact for field-based reimbursement and access support-related matters and is responsible for being the local market access expert on payer, policy, and processes to help providers navigate coverage and help support patients in obtaining coverage. Essential Functions (ES) and Responsibilities * Provide clear and detailed coverage, criteria and policy education to healthcare provider offices, physician owned infusion suites, ambulatory infusion suites, National and Regional Specialty pharmacies/Home Infusion providers and hospital-based outpatient infusion centers. * The (FRM) will work with the ADvantage Ig Patient Support Program (HUB) to help ensure clear and transparent communication between providers and ADMA. * Communicate technical knowledge of patient enrollment, prior authorizations, appeals, and ADMA Biologics sponsored HUB support programs. * Serve as the market access training lead for respective territory, delivering policy updates and program information as needed. * Collaborate in cross-functional meetings with Sales, Market access, and Medical Affairs as needed to help support providers. * This is a remote role and travel within your region and national meeting will be approximately (65-75%). * The FRM will have responsibility in supporting Providers and Sales in the following states: Northeast Region MA, ME, VT, RI, NH, CT. Mid-Atlantic Region: NY, NJ, PA, DE,VA, WV, DC, NC. Job Responsibilities or Job Requirements Competencies Ability to effectively manage staff. Ability to handle multiple priorities and tight deadlines. Understand concepts, requirements, and accounting issues for all business areas Ability to understand and interpret government regulations and customer specifications Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures Able to work in high-pressure, deadline-driven environment Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project) Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Exceptional organizational and communication skills required Must have a strong customer service orientation and able to work well under pressure while interfacing with all levels of personnel, and consultants Experience Requirements * 10 years of experience working for a major pharmaceutical organization on the field reimbursement team, understanding different site of care provider segments and payors, i.e., (Commercial, Medicare, Medicaid, VA/DOD/Tricare, and ACA) as well as a deep understanding of the Medical and Pharmacy benefits, billing and coding practices for infused products is required. * Extensive frontline experience working with and across the various infusion service areas within the US health care system. Specifically, Physician Buy and Bill offices, Ambulatory Infusion suites, National and Regional Specialty Pharmacies/Home Infusion Providers and hospital owned outpatient infusion centers. * Must be able to understand and clearly disseminate payor policy and criteria for coverage in the medical and pharmacy benefit to existing and future providers. * Must be able to think independently, analyze issues and make recommendations that will help providers and patients obtain coverage to start therapy. * Must have extensive Buy and Bill experience in Rare Disease, Plasma/IVIG, Oncology or Orphan Disease. * Strong understanding of healthcare regulatory and enforcement environments along with demonstrated integrity on the job. * Employees are responsible for ensuring compliance with all ADMA Quality policies, standards, and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. * Must be Proficient in Microsoft Office, Excel, and PowerPoint and Teams. * Strong people skills. * Excellent written and verbal communication skills. Preferred Experience Education Requirements: * BA/BS/RN degree required, preferably in life science, business, or nursing, master's degree a plus. RN is highly desirable. Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vesting Medical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ********************* ADMA Biologics is an Equal Opportunity Employer. Apply now