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
$89k-121k yearly est. 60d+ ago
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Senior Scientist, Production Operations
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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
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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
$76k-113k yearly est. 55d ago
Specialist QA II Manufacturing Oversight
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Specialist QA II Manufacturing Oversight in Boca Raton, FL!
Job Title: Specialist QA II Manufacturing Oversight
:
Position Summary
The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.
Essential Functions (ES) and Responsibilities
* Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
* Perform Quality Assurance review and approval of Deviation Reports.
* Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
* Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
* Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
* Review and release of Plasma pools to manufacturing.
* Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
* Review and release of raw materials in LIMS/SAP.
* Perform audits of Nitrogen receipt process.
* Perform notification and disposition of associated Lookback units.
* Assist with quarantining and release of critical systems, equipment, and controlled environments.\
* Write, review, and revise QA SOPs.
* Review SOPs and documents from other departments and provide feedback as necessary.
* Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
* Assist with training of new employees.
* Coordinate and perform any additional activities or projects assigned by QA Management.
* Experience with LIMS and SAP preferred.
Job Responsibilities or Job Requirements
Competencies
Exceptional organizational and communication skills required
Must have excellent writing and oral skills
Experience Requirements
EDUCATION REQUIREMENTS:
* Bachelor's Degree preferred but can be offset by experience.
EXPERIENCE REQUIREMENTS:
* 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.
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-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
$63k-92k yearly est. 6d ago
Technician, GMP Sanitization
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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, GMP Sanitization in Boca Raton, FL!
Job Title: Technician, GMP Sanitization
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Position Summary
This position is responsible for custodial duties related to the Quality Control and IgG areas. This includes sweeping, mopping, trash, and biohazard removal and other custodial/housekeeping duties as well as sanitization of general and environmentally controlled areas. Follows proper procedures for maintaining equipment, supplies and facilities in a cleanroom environment under cGMP. Responsible for written documentation of activities.
Essential Functions (ES) and Responsibilities
* Perform daily, weekly and monthly cleanings in QC and IgG areas according to defined procedures.
* Prepare cleaning solutions and rotate them per assigned procedures.
* Perform safety showers, checkups and cleaning.
* Follow current Good Manufacturing Practices (cGMPs).
* Light Maintenance duties: (painting, door repairs, light bulb change outs etc).
* Maintain training on all relevant procedures (SOPs).
* Maintain gowning qualification for entering Cleanrooms.
* Record daily, weekly and monthly cleanings in the cleaning logs.
* Perform sanitization of QC and IgG chambers and equipment per assigned procedures.
* Perform sanitization of Cleanrooms.
* Train in all relevant safety procedures.
* Pick up and dispose of trash and biohazardous waste from assigned areas daily.
* Maintain all designated equipment in clean and proper working order.
* Keep inventory of cleaning solutions and mops.
* Effectively communicate status of area and any problems or issues found.
* Other duties as assigned.
* Restock all gowning areas in MFG
* Organize new gowns and return used gowns to the truck once they arrive
Job Responsibilities or Job Requirements
Competencies
FDA Adherence
Experience Requirements
Education Requirements: High School diploma or equivalent.
Experience Requirements: One year previous custodial/floor cleaning 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-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
$33k-39k yearly est. 5d ago
Associate, Regulatory Affairs
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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
$67k-90k yearly est. 60d+ ago
Supervisor, Screening & Registration
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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:
Apply now
$54k-74k yearly est. 60d ago
Donor Screener
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 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). 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
$30k-39k yearly est. 22d ago
Senior Technician, Industrial Maintenance
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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
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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
$49k-67k yearly est. 60d+ ago
Engineer, Validation
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Engineer, Validation in Boca Raton, FL!
Job Title: Engineer, Validation
:
Position Summary
The Engineer, Validation provides validation support to Immunotherapy Production, Quality Control and Plant Engineering. This role also provides activity updates to Validation Manager on a regular basis to ensure compliance issues are being met.
Essential Functions (ES) and Responsibilities
Job Responsibilities or Job Requirements
Competencies
FDA Adherence
Experience Requirements
Education Requirements: Bachelor's degree in science or engineering.
Experience Requirements: 3+ years validation 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.
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$77k-100k yearly est. 5d ago
Phlebotomist
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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.
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$36k-43k yearly est. 13d ago
Donor Floor Supervisor
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
The individual in this position is responsible to provide supervision for all day-to-day activities on the donor floor and in the plasma processing area. These responsibilities include, but are not limited to management of production, regulatory compliance, scheduling activities, and human resources activities as required.
The Donor Floor Supervisor facilitates the coordination of day-to-day center activities to support the achievement of company goals and objectives. The Donor Floor Supervisor oversees the execution of the training plan and SOPs for staff members working on the donor floor and or in the plasma processing area. This individual actively works to provide an environment of teamwork and mutual respect between staff members. This individual works to ensure donor satisfaction is maximized with the intent of providing a safe, healthy, and friendly environment for both donor and staff.
This individual observes staff to confirm they are performing their work in compliance with SOP's and regulatory requirements. Any deviations from this standard are addressed as soon as possible to lessen the likelihood of reoccurrence. The Donor Floor Supervisor ensures high standards of customer service. The supervisor is responsible to ensure all activities within their area of responsibility are always prepared for audit.
The individual in this position provides supervision on the donor floor 90% of the time and 10% of the time will be spent in administrative tasks. This position provides a bridge between daily operations functions and center administration.
Essential Functions (ES) and Responsibilities
Key Duties (E):
* Ensures donor floor staff are trained and competent to perform job duties in accordance with the SOPs and regulatory requirement.
* Schedules trained staff to ensure sufficient staffing are to support safe and efficient donation activity and meet the expected staffing ratios.
* Actively monitors and directs donor flow to ensure donors are moving through the donor floor at the expected pace and makes necessary adjustment to meet expected donor time in center goals.
* Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs.
* 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.
* Works in cooperation with QA in areas such as monitoring of errors, developing, and implementing corrective actions, and to ensure the Center meet regulatory, cGMP, and customer requirements always.
* Monitors medical supplies usage and use of other company resources to confirm use as intended and in accordance with SOP and routinely monitors inventory against usage. Informs supervisor when supplies are needed.
* Monitors staff performance against existing standards and provides immediate correction to staff as needed. Follows company policies about the documentation and administration of disciplinary actions.
* Manages absences, attendance issues, and work task schedules on a proactive basis.
* Directly oversees donor satisfaction on a day-to-day basis and works to limit all unnecessary annoyances or delays.
* Provides input into staff annual evaluations.
* Sets an example of good work ethic and encourages good work ethic in staff.
* Maintains competence with all position required tasks.
* Travel required on an as needed basis.
* Additional duties as related to/supporting the needs of the business may be assigned by management as deemed necessary.
Supervisory Duties (E): Oversees donor floor employees.
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
ADMA Bio
Basic computer skills including experience with software programs such as Word, Excel, and GroupWise
Experience Requirements
Education Requirements: High School diploma or equivalent required.
Experience Requirements: Two years of phlebotomy experience required. Two years of successful supervisor experience in a medical setting required. Experience should include managing staff schedules and addressing performance issues. Previous experience operating an automated blo
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
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$28k-35k yearly est. 13d ago
Physician Substitute - LPN, RN or Paramedic
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Physician Substitute - RN, LPN or Paramedic.
Job Title: Physician Substitute - LPN, RN or Paramedic
:
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). 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.
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$45k-66k yearly est. 12d ago
Senior Manager, Analytical Development
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Manager, Analytical Development in Boca Raton, FL!
The Senior Manager, Analytical Development will support the development of analytical methods.
Job Title: Senior Manager, Analytical Development
:
Position Summary
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 Manager, Analytical Development in Boca Raton, FL!
The Senior Manager, Analytical Development demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Essential Functions (ES) and Responsibilities
* The Senior Manager will be responsible to direct the work of analytical development scientists.
* Oversees day to day operations of the analytical development team.
* Plans for future project including budget and timelines.
* Ensures project timelines are met.
* Serves as a process and scientific subject matter expert.
* Ensures compliance with cGMP process, training, procedures.
* Responds to reports from internal/external audits.
* Directs validation, development, and qualification studies and reports.
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 follow the cGMP's and procedures with great attention to detail
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
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs
Must be able to prepare, deliver spreadsheets, data analysis, presentations and facilitate for small and large groups
Must be independent and able to design experiments, processes, thinking critically with vision, and is responsible to analyze data and make recommendations to senior management regarding process improvements and development
Possess time management skills and be able to balance multiple job assignments at once
Possesses strong organizational, critical thinking, reasoning, and problem-solving abilities.
Protein purification
Strong organizational, interpersonal and collaborative skills
Experience Requirements
Education Requirements:
* Master's degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
* Bachelor's degree and 12 years of process development experience.
Experience Requirements:
* 10 plus years of experience developing protein purification processes.
* Minimum of 2 years of experience in a GMP environment.
Other Essential Knowledge:
* Protein biochemistry, especially immunoglobulin chemistry.
* Assay development.
* Assay validation.
* GMP method development and validation.
* Technical transfer of methods.
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.
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.
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
$112k-149k yearly est. 60d+ ago
Chemist II, Bioanalytics
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 II, Bioanalytics in Boca Raton, FL!
Job Title: Chemist II, Bioanalytics
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Position Summary
The Chemist II, Bioanalytics will perform quality control testing of raw materials, in-process, and final products with minimal supervision, with a concentration in immunoassays. Uses knowledge of corporate policies to resolve routine problems and ensure compliance with procedures.
Essential Functions (ES) and Responsibilities
* Perform quality control testing for raw materials, in-process, and final product samples, according to approved Standard Operating Procedures (SOPs) and cGMP guidelines
* Complete testing documentation and data entry as required for procedures and tests performed
* Apply knowledge of analyzing issues and uses judgment to make decisions
* Knowledge of immunoassays, specifically plate-based assays and ELISAs
* Utilize cGMP practices in documentation and execution of job functions
* Perform instrument calibration or qualification according to written procedures
* Write and revise SOPs and/or participate in validation protocol execution, as needed
* Perform testing, as needed, to generate data for qualification/validation and special projects
* Fulfill requests from management for assistance in other matters, as needed
* Accountable for following SOPs and adhering to cGMP guidelines
* Review documentation on trained tasks as assigned by QC management
* Use technical and scientific knowledge to recommend solutions to problems as directed by QC management
* Mentor junior analysts and provide training as requested on QC assays.
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: Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, or related science discipline.
Experience Requirements: At least three years of experience performing chemical/biochemical testing or developing immunoassays. Work in a regulated environment (FDA, EPA, etc.) is highly 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
* Company paid 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
$71k-96k yearly est. 60d+ ago
Trainer
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Trainer!
Job Title: Trainer
:
Position Summary
The Trainer develops, implements, administers and continuously improves the training program for ADMA Biologics. Ensuring that the training program is fully implemented at all levels of the organization.
Essential Functions (ES) and Responsibilities
* Promotes a culture of quality and operational excellence and ensures the advancement of the company's Mission and Values.
* Utilizes adult learning principles to design, create and develop learning solutions to meet learning objectives and accommodates a variety of learning styles.
* Deliver engaging learning solutions that produce the desired outcomes in responding to the learners needs.
* Assist in creating, scheduling, and facilitating training the centralized site-wide cGMP training program for all Boca Raton cGMP staff.
* Develops and facilitates training and development, learning initiatives, and training curriculum for specific roles and departments.
* Conduct New Hire Orientation training.
* Reviews and improves standard operating procedures and training programs used throughout the Company. Assists other functional areas in developing training materials associated with departmental SOPs.
* Participate in development of training metrics to maintain compliance.
* Provides feedback, where appropriate, to departments to ensure full compliance with established procedures and processes.
* Oversee job-specific departmental training to ensure program appropriateness and compliance. Assesses programs for effectiveness and initiate improvement plans where necessary.
* Assists in entering training information into the electronic quality management system.
* Assists, as needed, in processing training records, materials and assignments.
* Coordinates and performs any additional activities or projects assigned.
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 evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures
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)
Must be able to read, understand, and implement programs based on technical regulations and manuals
Must be project oriented, creative, and computer literate
Must have excellent writing and oral skills
Experience Requirements
Minimum of 2 years of experience in Manufacturing, Compliance, Quality Assurance or Quality Control, with at least one year leading training initiatives and continuous improvement in a regulated environment is required.
Education Requirements:
Bachelor's degree is required.
Preferred Experience
Compliance Requirements (ES)
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
$26k-39k yearly est. 30d ago
Senior Project Engineer
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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
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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
$80k-99k yearly est. 60d+ ago
Technician I, Purification
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 I, Purification in Boca Raton, FL!
Job Title: Technician I, Purification
:
Position Summary
This position is under direct supervision of the Group Leader. This experienced position is responsible for the manufacture of plasm products through protein separation and other tasks involving Ultrafiltration, Chromatography, and Nanofiltration.
Essential Functions (ES) and Responsibilities
* Cleans and sanitizes equipment before and after use.
* Responsible for production operations.
* Makes and verifies connections on flow panels.
* Performs pH and conductivity measurements.
* Performs chemical and buffer additions.
* Operation of Ultrafiltration system.
* Initiates product processes on the Process Automated System (PAS).
* Column chromatography using up to 80cm columns.
* Takes and prepares product samples.
* Orders and maintains raw material inventories.
* Complete batch records.
* Assists Group Leaders in training of other tech positions.
Job Responsibilities or Job Requirements
Competencies
Ability to follow the cGMP's and procedures with great attention to detail
Experience Requirements
Education Requirements: Bachelor's degree or equivalent experience.
Experience Requirements: GMP experience 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
$28k-36k yearly est. 60d+ ago
Manager, Laboratory
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Manager, Laboratory in Boca Raton, FL!
Job Title: Manager, Laboratory
:
* Independently manage the inventory and ordering for Analytical and Process Development Departments.
* Manage the department schedule for routine testing tasks and QMS tasks.
* Manage equipment maintenance and repairs.
* Participate critically in the Quality and Change Review Boards.
* Assist in the Technical Transfer of assays to other departments.
* Serve as an analyst in assay development and troubleshooting, with guidance.
* Perform routine immunological assays.
* Draft SOP's.
* Maintain knowledge of current QC assays and suggest areas for improvement.
* Maintain strict adherence to GMP documentation practices.
* Review the reports and work of other scientists on the team.
* Work collaboratively.
* Maintain knowledge of regulatory guidelines pertaining to assay development/qualification/validation.
* Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
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 InsuranceCompany 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
$57k-86k yearly est. 5d ago
Intern, Analytical Development & Quality Control
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Intern, Analytical Development and Quality Control in Boca Raton, FL!
Job Title: Intern, Analytical Development & Quality Control
:
Position Summary
The Intern, Analytical Development and Quality Control assists with laboratory projects by performing assays, basic statistical analysis, and routine laboratory functions as required. Presentation of work and progress to the team at the end of the internship.
Essential Functions (ES) and Responsibilities
* Perform biological or chemical based assays, analyze data, and prepare reports as necessary to fulfill individual project goals. Assist scientists with daily laboratory functions as required.
* This position may be filled within Analytical Development or Quality Control Departments.
* By the end of the internship, the successful candidate, will have learned to perform at least one assay, analyze data, and present work to the team. The successful candidate will also have a deeper understanding of the role of analytics within the pharmaceutical industry and have demonstrated GMP skills.
Job Responsibilities or Job Requirements
Competencies
Able to work in high-pressure, deadline-driven environment
Computer proficient with intermediate skills in office programs
Experience Requirements
* Education Requirements: Rising Biology/ Chemistry or related field Junior or Senior.
* Experience Requirements: One semester of laboratory coursework.
Preferred Experience
Compliance Requirements (ES)
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
$29k-37k yearly est. 5d ago
Field Reimbursement Manager Market Access
ADMA Biologics Inc. 4.6
ADMA Biologics Inc. job in South Burlington, VT
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 Market Access Field Reimbursement Manager (South Central Region and Florida)!
Job Title: Field Reimbursement Manager Market Access
:
Position Summary
The Market Access Field Reimbursement Manager (FRM) (South Central Region and Florida) 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.
* Maintain compliance with PHI/HIPAA and company policies.
* This role will cover the Central region and will be responsible for the central United States, as well as covering additional regions as needed.
* 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:
* Texas
* New Mexico
* Oklahoma
* Arkansas
* Louisiana
* Florida
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
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ADMA Biologics may also be known as or be related to ADMA BIOLOGICS INC., ADMA BIOLOGICS, INC., ADMA Biologics, ADMA Biologics Inc, ADMA Biologics, Inc., ADMA PLASMA BIOLOGICS INC. and Adma Biologics, Inc.