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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 DescriptionPrimary Job Title: Medical Laboratory ScientistAlternate/Related Job Titles: • Medical Technologist (MT), • Clinical Laboratory Scientist (CLS), • Medical Laboratory Technologist, • Position Type: Contract, • Contract Duration: 3.5 months (estimated), • Start: As Soon As Possible, • Follow all laboratory policies and procedures for specimen handling, analysis, reporting, and recordkeeping., • Maintain records demonstrating that proficiency testing samples are tested in the same manner as patient specimens., • Perform complex test analyses using approved methods and release validated results., • Adhere to quality control (QC) standards; document all QC activities, calibrations, and maintenance., • Identify and correct test performance issues, notifying supervisors of problems as necessary., • Maintain accurate documentation of all corrective actions when deviations occur., • Handle STAT and critical results according to laboratory protocol., • Maintain appearance and cleanliness of the laboratory work area., • Verify reagent/test kit details including received dates, expiration dates, and storage conditions., • Participate in safety training, departmental meetings, and regulatory inspections as required., • Collaborate with colleagues and other departments to ensure workflow efficiency and compliance., • Uphold patient confidentiality and demonstrate excellent customer service when interacting with clients.Required Experience:, • Minimum 1 year of clinical laboratory experience performing high-complexity testing., • Experience with laboratory information systems (LIS) and working across multiple computer platforms., • Knowledge of quality control (QC) and quality assurance (QA) best practices., • Proficiency in specimen processing and test result validation.Education & Certifications:, • BS in Medical Technology preferred; or BS/BA in Chemistry, Biology, or Associates degree in Laboratory Science or Medical Technology., • Eligibility for national certification as a Medical Technologist or Medical Laboratory Scientist (ASCP or AMT) preferred., • Candidates educated outside the U.S. must provide a credential evaluation from IERF (International Education Research Foundation)., • U.S.-educated candidates must provide original transcripts., • National and state licensure as required by law.Required Skills:, • Clinical Laboratory Testing, • Quality Control & Instrument Maintenance, • Data Accuracy & DocumentationPreferred Skills:, • Laboratory Information Systems (LIS), • CLIA, HIPAA & OSHA Compliance, • Specimen Handling & Troubleshooting, • Time Management & Prioritization, • Interdepartmental CommunicationAdditional Skills:, • Reagent Management & Inventory, • Training Participation & SOP Adherence, • Critical Results Reporting Benefits: * Medical, Vision, and Dental Insurance Plans * 401k Retirement Fund About the Client: A leading provider of diagnostic information services, empowering healthier lives through clinical testing and data insights. Leveraging the world’s largest laboratory database, the organization delivers innovative diagnostic solutions that help identify, treat, and prevent diseases while improving patient outcomes worldwide. About GTT: GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the U.S. and Canada. We look forward to helping you land your next great career opportunity! Job Number: 25-27088 #gttqst #gttjobs Company DescriptionGlobal Technical Talent is a subsidiary of Chenega Corporation () with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure. We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier. There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: Awards SIA’s Fastest Growing Staffing Firm: 2023 and 2015 SIA’s Best Staffing Firm to Work for: 2019 -2023 Inc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015 Randstad Preferred Supplier: 2020 - 2023 TechServe Alliance Excellence Award. 2019 NH Business Magazines Fast 5 fastest growing companies Ernst & Young Entrepreneur of the Year Finalist: 2015Global Technical Talent is a subsidiary of Chenega Corporation () with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.\r\n\r\nWe are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.\r\n \r\nThere is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: \r\n \r\nAwards\r\n\r\nSIA’s Fastest Growing Staffing Firm: 2023 and 2015\r\nSIA’s Best Staffing Firm to Work for: 2019 -2023\r\nInc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015\r\nRandstad Preferred Supplier: 2020 - 2023\r\nTechServe Alliance Excellence Award. 2019\r\nNH Business Magazines Fast 5 fastest growing companies\r\nErnst & Young Entrepreneur of the Year Finalist: 2015

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals 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 DescriptionScientist – Engineer, MSAT The Scientist-Engineer, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets. This includes leading projects in process development, technology transfer and continuous improvement of our client's novel manufacturing processes. Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all. • Accountable for the design and execution of experimental studies in the laboratory, for example:, • Perform laboratory experiments for client projects, • Perform analytical testing for client projects, • Preparation and scheduling of laboratory equipment for experiments, • Provide technical leadership of client products during manufacturing and development, for example:, • Direct technical communication with clients during manufacturing and development, • Support manufacturing in identifying and resolving manufacturing process constraints, • Lead the generation of manufacturing and development documentation, for example:, • Generating experiment protocols and reports for development projects, • Generating draft batch records and other manufacturing documentation, • Generating manufacturing risk assessments, such as FMEA, • Perform data analysis to reach actionable conclusions, for example:, • Compile and analyze experimental data, • Present experimental data internally and externally to clients, • Supervise direct reports.REQUIREMENTS, • Bachelor's degree in relevant life science or engineering discipline, • Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols, • Demonstrated ability to deliver projects to specific timelines and budgets, • Experience in working effectively and delegating tasks in a team-based environment, • Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications, • Basic understanding of the technical principles, theories and concepts of cell therapy or similar products, • Aseptic processing, Good Manufacturing Practice (GMP), communication skills, specific process and analytical equipment, • This job may require occasional evening and weekend work.

Job Description Clinical Testing Company seeks Medical Laboratory Scientist who will be responsible for performing routine and non-routine activities pertaining to laboratory testing and the reporting of results. 2 Shifts Available: Shift: Tuesday - Saturday 9:00am - 5:30pm Shift: Tuesday - Saturday 12:00pm - 8:30pm Will perform moderately difficult to complex tasks and will perform assigned analytical testing procedures in an accurate, precise, and timely manner. JOB RESPONSIBILITIES: • Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test result;, • Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;, • Analyze specimens using approved testing procedures (see department SOPs)., • Review and release test results., • Follow CLIA, HIPAA, OSHA, and safety guidelines as described in their respective guidelines., • Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and all maintenance performed;, • Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance., • Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify the senior technologist or supervisor., • Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications., • Follow department's procedure in reporting STATS or Critical results to clients., • If applicable, answer questions from customers or other lab personnel., • Maintain complete records of all testing performed on-site., • Maintain general appearance of the department., • Make sure reagents/test kits have received dates, expiration dates, and if applicable opened dates. 15. Review/train on new procedures., • Attend monthly department and any additional training/educational meetings., • Participate in all applicable safety training sessions. Know the location and contents of the safety manual. Know the location/use of all applicable safety equipment., • If needed, participate in government or regulatory agency inspections., • Perform other duties as directed by supervisor. Required Knowledge: • A solid understanding of basic laboratory testing is required for this position. The successful candidate must possess good computer skills and be able to adapt to working in multiple computer systems., • Must have knowledge of QC and QA as well as knowledge of all areas of the laboratory. Education: • BS in Medical Technology preferred; or BS/BA in Chemistry or Biology, or Associates degree in a Laboratory Science or Medical Technology, or, • Previously qualified as a Technologist under 42 CFR 493. 1433 published in March 14, 1990., • Foreign educated candidates must provide a detailed credential evaluation from IERF (International Education Research Foundation)., • United States educated candidates must provide a detailed original transcript., • A successful candidate should possess or be eligible for national certification as an MT / MLT from a recognized organization (ASCP or AMT). Work Experience: • 1 year Clinical experience (high complexity testing) preferred., • Minimum of 1 year of clinical laboratory experience in highly complex testing for those with BS/BA in Chemistry or Biology., • National and State licensure as required. Special Requirements: • Must have the ability to establish work priorities and handle several procedures simultaneously., • Must interact with other departments., • Contact with clients may be required, good customer service skills are important.