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Job DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.Other Information, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. QC Analytical Associate I is available as well.

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of QC Microbiology, responsibilities of the QC Microbiology Engineer I will include but are not limited to: Microbiological Testing: • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required, • Training in GxP/ GDP, Safety, • Minimum 0-2 years of experience or equivalent experience., • Microbiology testing or within the biopharmaceutical industry experience preferred., • Proficient with computer software; Microsoft Office, • Strong written and oral communication skills, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels, • Must be able to work during the weekend, holidays and as required by the company, • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer II The Quality Control Microbiology Engineer II will support two local sites serving as a support role to clinical and commercial production. The QC Microbiology Engineer II will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer II will include but are not limited to: Microbiological Testing:, • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Writing/conducting investigations pertaining to microbiological testing, • Develop and train QC Microbiology Engineer I personnel on relevant business processesREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 2-4 years of experience with microbiological testing or within the biopharmaceutical industry., • Training in GxP/GDP, Safety, • Proficient with computer software such as; Microsoft Office, • MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical writing skills, • Technical training ability, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Supervisory Responsibility, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • Employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator., • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer III The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer III will include but are not limited to:, • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Supervisory Responsibility; Direct reports, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • Must have the ability to work in a team-oriented environment and with clients., • Must be able to work during the weekend, holidays and as required by the company

Job DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Team Leadership - Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles: QC Microbiology Associates, • Investigate and document non-confirming events and environmental excursions., • Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals., • Interact with other Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites., • Participate in department and cross functional meetings., • Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Author and revise Standard Operating Procedures, Work Instructions, forms and Protocols to reflect current practices., • Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports., • Provide staff development through feedback aimed towards performance development and review., • Ability to remain focused and effective in high stress situations., • Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect., • Able to handle challenging interpersonal relationships., • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Aseptic Processing StandardsREQUIREMENTS, • BS in Microbiology or relevant field required., • Biotechnology Certificate and/or cGMP experience, • Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry., • Strong knowledge of microbiological test methods, philosophies, method validation and method transfer., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office, Excel, and MODA., • Must have ability to work in a team-oriented environment and with vendors., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The employee must be able to comply with personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role., • An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects., • Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear., • The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance), • Heavy cryo-gloves must be used when working with liquid nitrogen, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description We are conducting a search for an experienced Director of Quality Control / Quality Assurance to lead and manage our quality programs in a fast-paced, high-volume food manufacturing environment. The ideal candidate is a certified SQF Practitioner with a proven track record of successful third-party, regulatory, and customer audits, and extensive experience in both foodservice and retail segments. This leadership role is critical to ensuring our products consistently meet the highest standards of safety, quality, and compliance. What You'll Do: • Direct and oversee all QC/QA activities across food manufacturing operations., • Maintain and improve the company’s SQF program; act as the designated SQF Practitioner., • Lead all audit activities (SQF, FDA, , customer, and third-party), ensuring successful outcomes and timely resolution of non-conformities., • Implement and monitor HACCP plans, food safety systems, GMPs, SOPs, and other quality-related programs., • Supervise and develop the QA/QC team; drive a culture of accountability and continuous improvement., • Partner with cross-functional teams including Operations, R&D, and Supply Chain to optimize product quality and efficiency., • Ensure thorough documentation, traceability, and compliance across all quality-related functions., • Manage and respond to customer complaints, deviations, and corrective/preventive actions (CAPAs)., • Monitor industry trends and regulatory updates to ensure ongoing compliance. What You'll Bring: • Bachelor’s degree in Food Science, Microbiology, or related field., • Certified SQF Practitioner (REQUIRED)., • Minimum 10 years of QA/QC experience in the food manufacturing industry, with leadership responsibilities., • Demonstrated success managing quality in both foodservice and retail channels., • Proven track record of passing regulatory, third-party, and customer audits., • Deep understanding of HACCP, GMPs, FSMA, FDA regulations., • Strong organizational, communication, and leadership skills., • Ability to thrive in a high-speed, hands-on manufacturing environment., • Experience with refrigerated, shelf-stable, or specialty food products is a plus., • Bilingual (English and Spanish) is a plus

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Job Title FIELD SUPPORT ENGINEER TIER 1 Department FSE – Field Service Engineers Company COPAN DIAGNOSTICS, INC Department Scope The Field Service Engineer is involved in all areas of microbiology equipment technology. This position is responsible for new equipment inspections and installations, administering preventative maintenance (PM), calibrating and performing electrical safety tests (EST) on automated microbiology equipment, monitoring work order requests, troubleshooting, completing repairs, and documenting all service activities. PROCESS & KEY ACCOUNTABILITIES Process Key accountabilities SPECIFIC ACTIVITIES Perform tasks associated with the installation, maintenance, repair, troubleshooting, and assembly of automated microbiology equipment involving basic knowledge and abilities associated with electronics, robotics, and mechanical processes. Achieves performance measures associated with the maintenance of equipment, productivity, customer satisfaction, and other performance standards. Complete all necessary documentation of activities involving the servicing of equipment in accordance with the manufacturer's requirements. Serves as a resource for the proper operation and maintenance of equipment. Instructs instrument operators in proper equipment use. Adheres to the highest level of customer service while managing customer requests with diplomacy. BASIC COMPETENCES Reliable and able to work independently with limited supervision Excellent customer service skills Outstanding communication abilities Computer literacy Ability to read instrument schematics JOB LEVEL SKILLS Associate’s degree in Industrial, Electrical, or Mechanical Engineering, or minimum 2–3 years of equivalent formal related training Comfortable working in clinical environments with infectious agents and biohazards Willingness and ability to work outside normal working hours, including weekends and holidays Ability and willingness to travel extensively (approximately 75%) with minimal notice PHYSICAL REQUIREMENTS Must be able to sit for long periods (e.g., on airplanes or in vehicles) Must have manual dexterity to operate job-related equipment and tools Must be able to occasionally lift and/or move up to 75 lbs Must be able to occasionally crouch, kneel, and/or duck into tight spaces Must be able to stand for long periods Extended kneeling and crouching may be required WORK ENVIRONMENT Frequent travel to off-site job locations Work is often performed in clinical or laboratory settings Exposure to infectious agents and biohazards Unpredictable scheduling, including work on weekends and holidays Pay Rate: $35.00 Hourly-Non Exempt. Company DescriptionBe a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab, and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for the automatic segregation of bacterial cultures, followed by automated colony picking.Be a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab, and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for the automatic segregation of bacterial cultures, followed by automated colony picking.

Job Description The Lab Technician is a position that works in a high performance, customer focused Team environment and is responsible for conducting the daily tasks associated with the Quality Assurance laboratory to maintain the high quality of products produced. The Lab Technician will be responsible for the inspection of raw materials, ingredients and products manufactured to ensure compliance with all internal and customer required specifications through the excellent performance of assigned duties. These actions are to be performed while keeping safety as a primary objective and following all established Good Manufacturing Practices (GMP’s), Regulatory, and Company policies and procedures. As an integral member of the Quality Control Team, the Lab Technician plays a pivotal role in ensuring that a high level of collaboration and flexibility occurs between the QC Team and all other support and production departments to not only meet but exceed the operational and production goals set for the facility while making sure that the Quality of our products and the safety of ourselves and others remain a top priority. Essential Duties & Responsibilities: • Approving incoming components by confirming all materials meet required specifications; this is done through conducting both visual and measurement tests; responsible for rejecting and returning all unacceptable materials., • Confirms all in-process production meets required specifications and approves products when visual and measurement tests have proven product meets designated stipulations; must effectively communicate any and all required adjustments to the Production Supervisor., • Approves finished products by confirming specifications are met and conducting visual and measurement tests; prepares certificates of analysis and any certificates of compliance as needed., • Documents inspection results by fastidiously completing reports and logs accurately and with timeliness., • Excellent data entry skills required for inputting accurate and detailed data into the quality database, • The ideal candidate will be proactive in discovering deviations from company and customer standards and providing immediate notification to operators and supervisors, • Responsible for monitoring and inspecting process control points, critical control points, and essential quality attributes, an employee in this role must be familiar with all the essential quality attributes of AAK Foodservice products., • Keeps measurement equipment operating by following operating instructions; calibrating equipment and assist with submissions of work orders when needed., • Collects and submits samples to outside laboratories as needed., • Maintains safe and healthy work environment by following standards and procedures, complying with legal regulations., • Accomplishes quality and organization mission by completing related results as needed., • Verifies cleanliness of equipment while working in conjunction with sanitation personnel., • High school diploma, GED required, • AAS or BS degree in a laboratory science (e.g. in microbiology, biochemistry, biology, food technology), or Experience as a QA Technician in a food or like manufacturing (consumer products) environment or equivalent experience in an industrial lab required, minimum of 2 years., • Auditing experience preferred but not required., • Demonstrated technical knowledge in Quality Processes and systems including but not limited to: SPC, HACCP, Operating procedures, and Manufacturing practices., • Ability to work with minimal supervision in a fast-paced environment, • Ability to make objective and independent decisions, • Ability to read, write, and comprehend written instructions, product specification sheets, work instructions, technical documents and manuals., • Bi-lingual English / Spanish preferred, • Strong written and verbal communication and interpersonal skills., • Ability to introduce information to a group or in a group meeting, perform training to new employees, and assist in preparing new procedures, work instructions, etc., • Demonstrated ability to perform with consistent accuracy with detail-oriented work., • Ability to prioritize multiple tasks and organize work efficiently. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to stand; walk; use hands to fingers; reach; stretch; bend; kneel; crouch; climb; balance; etc., • The employee must regularly lift and/or move up to 50 pounds. Plant operations, environment and hours. Able to manage through urgent situations. The job is performed in a manufacturing plant environment. Exposure to loud noises, dust, dirt, heat, sparks, oil, and smoke may occur—earplugs / ear protection required in this area. Personal protective equipment (safety glasses, steel-toed shoes, appropriate clothing) is required in manufacturing plants.

Job DescriptionQuality Control Microbiology Analyst II, III QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology. • Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Writing/conducting investigations pertaining to environmental monitoring and testing, • Develop and train QC Microbiology Analyst I personnel on relevant business processes.REQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry., • GxP/GDP, Safety Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical training ability, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring., • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Analyst II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work ordersREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • GxP/GDP Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityWorking Environment, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityPhysical Requirements, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be physically capable to stand; walk; site; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear., • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Position & Client Overview: Our client located in northern New Jersey is currently interviewing for a permanent microbiology manager for their busy, high volume physicians operated laboratory. This is a day shift position that requires advanced microbiology experience and certification. This is a brand new state of the art facility. Salary: $120,000 Living in Clifton, NJ means experiencing a true four‑season climate, with average temperatures ranging from winter lows around 24–28°ree; to summer highs that typically reach 84–85°ree;. The town blends suburban calm with easy access to urban energy, offering plenty to do year‑round. Outdoor lovers enjoy parks like Garret Mountain Reservation for hiking, picnicking, and scenic views, while colder months bring opportunities for snowy walks and cozy indoor escapes. Indoors, residents take advantage of local restaurants, shopping centers, fitness studios, and community events that keep things lively no matter the weather. The mix of varied temperatures and diverse activities makes Clifton feel both dynamic and comfortably familiar. Job Summary: Responsible for the management and administrative functions for the laboratory. Responsible for policy development and implementation, regulatory compliance and quality assurance. Supervision is exercised over laboratory supervisors, clinical staff and support staff. Skill Requirements: • Managing and authoring processes and procedures, • Training and presenting technical information to staff, • QA/QC of the departments, • Fiscal and budgeting responsibilities Responsibilities include but not limited to: • Evaluating laboratory operations consulting with pathologists; reporting results according to protocols mandated by the hospital and public health department, • Ensuring maintenance of medical laboratory equipment performance by developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair, • Maintaining medical laboratory supplies inventory, determine inventory level; anticipating needed supplies, • Maintaining laboratory productivity, monitoring workload, identifying peak and slack periods, • Participating in the hospital quality assurance program; consulting with pathologists; performing proficiency surveys; reviewing QC & QA programs, • Maintaining medical laboratory staff by recruiting, selecting, orienting, training employees, counseling, reviewing/evaluating and disciplining employees as needed, • Complying with state and professional continuing education licensure requirements, • Contributing to benchwork as needed Education, Certification, & Experience: • Bachelor's degree in biology, • ASCP or equivalent certification, • Four years of advanced microbiology experience HealthCare Connections, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, religion, national origin, disability, pregnancy, protected veteran status, sexual orientation, gender identity, genetic information or other protected status pursuant to law. #IND

Job DescriptionQuality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology. • Environmental monitoring in controlled environments: Non-viable particulate monitoring; Active viable air monitoring, Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring: Ensure equipment is in proper working conditions; Ensure all equipment is properly; maintained/calibrated; Assist with routine laboratory testing; Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required; Minimum 0-2 years of experience or equivalent experience. Environmental monitoring or within the biopharmaceutical industry experience preferred., • Proficient with computer software such as; Microsoft Office, • Strong written and oral communication skills, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Trained in GxP/GDP, Safety, • The QC Microbiology Analyst I must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology., • Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Writing/conducting investigations pertaining to environmental monitoring and testing, • Develop and train QC Microbiology Analyst I personnel on relevant business processes.REQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry., • GxP/GDP, Safety Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical training ability, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring., • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Analyst II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work ordersREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • GxP/GDP Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityWorking Environment, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityPhysical Requirements, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be physically capable to stand; walk; site; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear., • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.