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Job Description QC Analyst I–III Relocation Package Available (U.S. Citizens Only) Global Life Science Hub is recruiting on behalf of a rapidly growing biopharmaceutical company in New Jersey seeking QC Analysts (Levels I–III) to join their expanding Quality Control team. This is an exciting opportunity to contribute to the development and manufacturing of biologics in a state-of-the-art GMP facility, with a full relocation package offered for qualified U.S. citizens willing to move to New Jersey. Role Overview: As a QC Analyst, you will play a key role in performing analytical and microbiological testing to ensure product quality and compliance with regulatory standards. The role requires a minimum of 1 year of hands-on QC or GMP laboratory experience in the pharmaceutical/biotechnology industry. Key Responsibilities: • Perform analytical and/or microbiological testing of raw materials, in-process samples, and finished products under GMP., • Execute assays such as PCR, ELISA, HPLC, flow cytometry, and cell-based assays (depending on level and background)., • Support method qualification, validation, and transfer activities., • Document and review laboratory results in accordance with ALCOA+ and data integrity standards., • Contribute to deviation investigations, CAPAs, and change controls., • Maintain, calibrate, and operate laboratory instruments to ensure readiness for use., • Participate in audits, inspections, and continuous improvement initiatives. Requirements: • Bachelor’s or Master’s degree in Biology, Biotechnology, Chemistry, or related field., • Minimum of 1 year QC or GMP laboratory experience is required., • Analyst I: 1–2 years QC experience., • Analyst II: 2–4 years QC experience in GMP biopharma., • Analyst III: 4–6+ years QC experience with expertise in analytical/cell-based methods and mentoring., • Strong knowledge of GMP, FDA, and ICH guidelines., • Detail-oriented with strong documentation and organizational skills. Why Apply? • Competitive compensation and benefits package., • Relocation package offered exclusively to U.S. citizens willing to relocate to New Jersey., • Career development opportunities across QC levels with exposure to biologics and cell/gene therapy., • Join a collaborative and growing biopharma company shaping the future of medicine.

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

Chemistry Lab Associate The Chemistry Lab Associate at Scientech Laboratories is responsible for independently executing established analytical methods, processes, and procedures for the preparation and analysis of samples from OTC drug, Pharmaceutical, and Cosmetic industry clients. Reports to: Laboratory Manager Collaborates with: Laboratory and Quality Assurance colleagues ROLES & RESPONSIBILITIES • Independently run validated methods for a variety of analytical chemical analyses on laboratory instruments (LC, GC, IR, UV, dissolution, viscosity, melting point, and others)., • Prepare samples of OTC drug, prescription pharmaceutical, cosmetic, dietary supplement, and botanical products for analysis in the above methods., • Process data from instruments (LC, GC, and others) to produce results ready for data review and QA., • Document experiments, analyses, and results accurately in lab notebooks or software systems in an FDA cGMP compliant manner. Ensure that all laboratory work complies with regulatory standards (e.g., FDA, DEA, ISO)., • Help maintain equipment, chemicals, reagents, and disposables supplies., • Follow safety protocols to handle chemicals, equipment, and waste properly. REQUIREMENTS • Bachelors degree in Chemistry with 1-2 years relevant laboratory work experience in Industry., • Experienced with following laboratory SOPs to prepare samples for analysis, run experiments, collect data, and report results., • Experience with HPLC and/or GC methods and instrumentation., • Experience working in an FDA-regulated environment, preferably cGMP., • Independently manages own day-to-day activities to support lab objectives., • Organized and able to plan work efficiently and effectively., • Independent, yet a great team player., • Ability to consistently deliver on-time results for clients., • This is a 100% onsite position.

Our pharmaceutical client is looking for a chemist to join their growing organization! If you are someone who wants to be a part of a highly technical team, this may be the role for you! The Chemist II/III will conduct release and stability testing for pharmaceutical products with specific focus on LC and GC chromatographic analyses as well as dissolution testing. This position involves conducting various analytical tests to ensure the quality and performance of solid dosage forms while maintaining a high level of laboratory safety and compliance. Key Responsibilities: • Prepare solid dosage samples for analysis by accurately weighing, blending, and homogenizing materials to ensure representative samples for testing., • Conduct dissolution testing of solid oral drug products using USP Apparatus I and Apparatus II., • Perform HPLC assays for the quantitative analysis of pharmaceutical components, including potency, purity, and samples from dissolution testing., • Ensure analytical instrumentation is properly maintained., • Ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs)., • Maintain accurate and detailed records of experiments, results, and procedures in laboratory notebooks and electronic systems, ensuring data integrity., • Adhere to safety protocols and participate in laboratory safety initiatives, ensuring a safe and compliant work environment. Minimum Qualifications: • Bachelor’s degree in chemistry with at least two (2) years of experience in the pharmaceutical industry., • Hands-on experience with HPLC, GC, Dissolution, and use of Empower software, • Strong analytical and problem-solving skills., • Excellent communication and teamwork skills., • Attention to detail and commitment to maintaining data integrity.

Job Description Job Summary: The EVP, Scientific Affairs oversees the operations of the Quality Assurance and Quality Control Departments for all divisions across multiple locations and has overall responsibility for the technical operations and the strategic planning of adequate resources needed to ensure the required quality of laboratory operations meet business requirements and customer deliverables. They will develop, implement, and periodically evaluate the QC/QA Department activities to ensure the organization’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization to meet the requirements of customers, consumers, and regulatory and accrediting agencies. The role is also responsible for ensuring cGMP compliance across all business divisions within the Company. The EVP, Scientific Affairs will be accountable for the timely release of products at all steps of the Manufacturing process, based on justifiable rationale, valid scientific data, process control items, etc. Principle Responsibilities: • Directs all Scientific Affairs and assumes responsibility for all Quality related matters; sets priorities and oversees the daily efforts of the QC/QA Team., • Provides guidance and works with various Departments in maintaining cGMP compliance within all business divisions of the Company., • Initiates Quality processes that drive continual improvement within the organization., • Conducts internal quality control audits and random inspections of each site’s Quality Management System as required and periodically reports on status of quality control and operations to executive leadership and, when required, regulatory agencies., • Provides support for third party cGMP certification audits and ensures appropriate corrective actions are conducted., • Directly involved with on-site regulatory (FDA, NJ-DHHS, etc.) inspections as well as internal and third-party audits and writing and overseeing responses to audits to comply with cGMP and GLP. Serves as the contact person and co-hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations., • Facilitates communication among production divisions and management. Provides support to Manufacturing and Product Development as required to troubleshoot production problems and collaborates with management and senior staff across production departments and roles to draft acceptable quality standards., • Evaluates internal and external laboratory capabilities. Recommends new testing procedures and equipment to support cGMP and customer specific requirements., • Develops and implement standards, methods, and procedures for inspection and testing, validation of systems and analytical processes, documentation, and change control systems that ensure the identity, purity, strength, and composition of ingredients and finished products are to specifications., • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements and monitor the compliance through robust internal audit program., • Ensures all laboratory controls and functions and all Quality Control functions as designated in 21 CFR GMP Part 110, 111 and 117 are in place, documented, monitored and enforced to maintain the QC Lab within a cGLP environment at all times., • Assess test results and approve recommended changes., • Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance., • Select, upkeep, calibrate, recertify, and document all instrumentation in the QC lab., • Oversee lot release of components, raw materials, and finished products., • Develop raw material specifications and finished product specifications once material has been through the Product Development process and route for signature., • Ensure sampling and testing priorities are consistent with Manufacturing, Production, and Customer Service schedules., • Preparation of analytical documentation (OOS, deviation reports, test methods, change controls, Certificate of Analysis) for incoming raw materials and finished goods., • Review technical control documentation (SOPs, Batch Records, test methods, specifications, COAs, etc.) from a Quality and Compliance perspective; ensure continuous improvement of departmental SOPs to stay up to date with regulatory and compliance guidelines; create, revise, and gain approval to implement lab SOPs and procedures and to review qualification documents for laboratory instrument/software as is necessary., • Maintain and improve department performance to meet requirements of Regulatory Authorities as well as the policies and standard procedures of the company., • Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories., • Provide technical guidance for validation of analytical methods and develop overall strategy to manage all critical reagents, reference standard, and reference control materials used in the laboratory., • Establish proper communication channels to manage, mentor direct reports to higher levels of management capability and provide strategic leadership to further strengthen the platform with a highly functional QC team., • Plan strategically/proactively with management of other platforms to ensure that resources are allocated adequately to meet each program’s needs., • Ensure that QC decisions are aligned with governance from Company Procedures and regulatory requirements., • Coordinate management structure of the laboratory to build Analytical datasets (release, and analytical verification) for Starting materials, In Process and Finished goods., • Identify gaps and assist with annual budget at both CAPEX and Operation levels. Direct – AVP, VP or Director of QC, QC/QA Team Indirect – Production Staff Supervisory Responsibilities: • Directs and oversees the quality control and quality assurance departments and supervisory staff., • Train QC/QA Team as necessary and validate their work periodically., • Perform annual performance reviews that are timely and productive and develop training plans with direct reports., • Handle discipline and termination of employees in accordance with company policy., • Ensure staff are provided with corporate communications. To perform this job successfully, an individual must be able to perform each principal responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education: BS degree in Chemistry, Engineering or Life Sciences required. Advanced degree preferred. Experience: 10 years in the manufacturing QC/QA field with a minimum of 5 years supervisory experience directing QC/QA and Documentation function within the Nutraceutical or Dietary Supplements industry is required. Solid overall knowledge of USP, FCC, and FDA guidelines as applied to testing of cosmetic and dietary supplement ingredients and finished goods. Experience leading FDA inspections is highly desirable. The desirable candidate will also be knowledgeable in analytical instrumentation (i.e., HPLC, GC, UV-Vis, FT-IR, Atomic Absorption, TLC and USP dissolution apparatus 1 and 2). Working knowledge of product stability studies and microbiological analysis of raw materials, in-process and finished goods required. Physical Requirements: Work requires ability to lift up to 25 pounds; sitting, standing, walking, bending and/or stooping for periods of five hours or more; moving and examining objects at high and low reach, and reading for periods of three hours or more; prolonged periods working on a computer. Position requires normal visual acuity. Additional Skills and Qualifications: Proven experience managing technical services and staff. Demonstrated knowledge of current cGMP requirements, regulations and standards to ensure the maintenance of the cGMP standard of quality. Thorough understanding of quality control standards and methodologies. Thorough understanding of manufacturing and production in the industry. Ability to read and interpret documents such as safety rules, operating and maintenance work instructions, procedure manuals and SDS sheets. Must have the ability to communicate effectively orally and in written form. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals. Must understand and use advanced statistical methods. Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Must have ability to solve complex problems involving multiple variables in standardized situations. Must have a deliberate and acute sense of documentation of all activities while in the manufacturing environment. Must be proficient with and be able to communicate via e-mail. Must be proficient with and able to use computer software including word processors & spreadsheets (Microsoft Word, Excel, Access), and ERP System. Proficient in oral and written communication skills. Must be able to communicate effectively in a cross functional team environment to complete work tasks as instructed. Must have sound judgment and decision-making skills. Excellent organizational skills and demonstrated attention to detail and thoroughness are critical. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Vital Health America is an Equal Opportunity Employer Company DescriptionVital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.Vital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.

Job Description Key Responsibilities: 1. Formulation Development: o Develop and optimize pest control formulations, including insecticides, rodenticides, repellents, and larvicides. o Tailor formulations to meet efficacy, safety, environmental, and regulatory requirements. 2. Product Testing and Evaluation: o Conduct laboratory and field tests to evaluate product effectiveness against target pests. o Assess physical and chemical stability, efficacy, and environmental impact under various conditions. 3. Regulatory Compliance: o Ensure formulations comply with local, national, and international regulatory standards (e.g., EPA, EU regulations). o Prepare and submit technical documentation for regulatory approval. 4. Research and Innovation: o Explore and integrate emerging active ingredients, delivery systems, and sustainable practices into product development. o Stay informed about new technologies and advancements in pest control chemistry. 5. Process Improvement: o Collaborate with manufacturing teams to scale up formulations and optimize production processes. o Troubleshoot issues during scale-up and recommend improvements for quality control. 6. Documentation and Reporting: o Maintain accurate lab records, including experimental design, data analysis, and findings. o Prepare detailed technical reports and present research results to internal and external stakeholders. 7. Collaboration and Teamwork: o Work with cross-functional teams, including biology, regulatory, and marketing teams, to ensure product success. o Liaise with suppliers and external research organizations as needed. Qualifications: Education and Experience: • Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Agricultural Science, or a related field., • 2+ years of experience in pesticide formulation, pest control product development, or related fields preferred. Technical Skills: • Strong knowledge of pesticide chemistry, toxicology, and modes of action., • Experience with analytical techniques such as HPLC, GC-MS, or FTIR for active ingredient analysis. • Familiarity with encapsulation, emulsification, and other delivery technologies. Soft Skills: • Excellent problem-solving and analytical thinking abilities., • Strong written and verbal communication skills., • Ability to work effectively in a team-oriented and fast-paced environment. Preferred Qualifications: • Experience with biodegradable and environmentally friendly pest control solutions., • Knowledge of integrated pest management (IPM) practices and their implementation. We’re proud of the investments we’ve made in our team, having grown from four to 1000 employees and evolving into one of the leading recruitment and staffing solution providers in the industry. Our recruiters and account managers are passionate about connecting qualified professionals with the right positions in small, medium, and large companies. Our Services W3Global understands the natural ups and downs of an organization’s staffing needs. We are continuously adapting to industry and economic changes to find the right candidates. We specialize in placing permanent, direct, contract, and temporary positions for companies of any size. Our recruiting services include sourcing, recruiting, screening, interview management, salary negotiations, training, and onboarding. We are committed to helping organizations redefine their recruitment process by delivering our SaaS-based proprietary application tracking system software. Our Expertise W3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs. As a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.W3Global was established in 2006 in Fremont, CA with a vision: simplify the recruiting process and develop an industry-disrupting platform to connect candidates with clients. Our cutting-edge Applicant Tracking System enables us to find the right person for the right job, creating value for job seekers and employers. While W3Global initially focused on IT staffing, we have expanded the business to serve many other industries, including accounting and finance, legal, engineering, human resources, government and more.\r\n\r\nWe’re proud of the investments we’ve made in our team, having grown from four to 1000 employees and evolving into one of the leading recruitment and staffing solution providers in the industry. Our recruiters and account managers are passionate about connecting qualified professionals with the right positions in small, medium, and large companies.\r\n\r\nOur Services\r\nW3Global understands the natural ups and downs of an organization’s staffing needs. We are continuously adapting to industry and economic changes to find the right candidates.\r\n\r\nWe specialize in placing permanent, direct, contract, and temporary positions for companies of any size. Our recruiting services include sourcing, recruiting, screening, interview management, salary negotiations, training, and onboarding.\r\n\r\nWe are committed to helping organizations redefine their recruitment process by delivering our SaaS-based proprietary application tracking system software.\r\n\r\nOur Expertise\r\nW3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs.\r\n\r\nAs a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.

Job DescriptionDescription: length of assignment: 6 months Work hours per day: 8 hours (Monday through Friday; 40 hours/week) Interview Process: Teams (other arrangements possible as needed) Job Responsibilities: • Perform analysis of samples and raw materials using chromatographic, spectroscopic, wet chemistry, physical testing and other analytical techniques. Techniques utilized include specific gravity, viscosity, potentiometric titrations, Karl Fisher, TLC, pH, liquid chromatography, gas chromatography, FTIR, others., • Apply existing test methods and procedures to complete the required analytical testing., • Collects, process and interpret accurately results, derive conclusions based on sound science, and prepare reports to effectively communicate results and findings to key stakeholders (audience with and without scientific backgrounds)., • Perform root cause analyses for non-conformance events related to laboratory testing., • Communicate effectively with management regarding testing statuses of projects., • Adhere to written procedures and practices to ensure good quality, compliance, and safety., • Ability to quickly adapt to changes, delays, or other unexpected events, and prioritize the work to ensure on time delivery of results and critical project milestones., • Communicate effectively with management regarding testing statuses of projects., • Adhere to written procedures and laboratory practices to ensure good quality and compliance., • Adhere to site and department’s health and safety guidelines and maintain personal and shared workspace., • Adapt to changes, delays, or other unexpected events, and prioritize the work to ensure on time delivery of results and critical project milestones. Qualifications: • Bachelor’s degree in Chemistry, or related field, with 1-3 years of professional experience, • Working knowledge of pH, TLC, Auto-titrators, FT-IR, Karl Fisher, Viscosity, and along with other wet chemistry analysis., • HPLC experience (preferred) and GC experience, • Strong written and verbal communication skills required., • Demonstrate ability to work in a diverse environment to manage multiple projects simultaneously and meet timelines., • Capability of working independently as well as working in a fast paced team driven environment, • Excellent bench skills and organization while maintaining a safe work environment., • Experience with Empower, ELN and LIMS software preferred Interview Process: Teams (other arrangements possible as needed) Job Responsibilities: • Perform analysis of samples and raw materials using chromatographic, spectroscopic, wet chemistry, physical testing and other analytical techniques. Techniques utilized include specific gravity, viscosity, potentiometric titrations, Karl Fisher, TLC, pH, liquid chromatography, gas chromatography, FTIR, others., • Apply existing test methods and procedures to complete the required analytical testing., • Collects, process and interpret accurately results, derive conclusions based on sound science, and prepare reports to effectively communicate results and findings to key stakeholders (audience with and without scientific backgrounds)., • Perform root cause analyses for non-conformance events related to laboratory testing., • Communicate effectively with management regarding testing statuses of projects., • Adhere to written procedures and practices to ensure good quality, compliance, and safety., • Ability to quickly adapt to changes, delays, or other unexpected events, and prioritize the work to ensure on time delivery of results and critical project milestones., • Communicate effectively with management regarding testing statuses of projects., • Adhere to written procedures and laboratory practices to ensure good quality and compliance., • Adhere to site and department’s health and safety guidelines and maintain personal and shared workspace., • Adapt to changes, delays, or other unexpected events, and prioritize the work to ensure on time delivery of results and critical project milestones. Qualifications: • Bachelor’s degree in Chemistry, or related field, with 1-3 years of professional experience, • Working knowledge of pH, TLC, Auto-titrators, FT-IR, Karl Fisher, Viscosity, and along with other wet chemistry analysis., • HPLC experience (preferred) and GC experience, • Strong written and verbal communication skills required., • Demonstrate ability to work in a diverse environment to manage multiple projects simultaneously and meet timelines., • Capability of working independently as well as working in a fast paced team driven environment, • Excellent bench skills and organization while maintaining a safe work environment., • Experience with Empower, ELN and LIMS software preferred, • Basic knowledge of the Microsoft Office Suite

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements: If this sounds interesting to you, it’s probably because up to this point you have: • A science degree, specifically in Microbiology., • Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency., • Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology., • Thrived in an environment where growth and change are rapid., • Strong Quality Control background preferred. The main responsibilities for this position are: • Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies., • Revise quality and compliance standard operating procedures as required., • Review Quality Control method validation and method transfer protocols/reports., • Assist with Internal Audits., • Collaborate in management of deviations/CAPAs/change controls., • Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance., • Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Job Description One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years' experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chemical and instrumental techniques on APIs, raw materials and finished products according to schedule. Must have the technical ability to understand client requirements and assist in the preparation of testing protocols. • Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC,UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies., • Prepare standards and samples for analysis., • Perform physical, chemical and instrumental techniques on APIs, raw materials and finished products., • Execute method transfer and validation protocols., • Document work clearly and accurately., • Perform technical writing and peer review as needed., • Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples., • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of product testing experience in a GMP laboratory., • ICP-MS/OES experience required., • Previous data acquisition software (Totalchrome, Empower, etc.) experience required., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs.Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

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 DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

**This is a first shift opportunity, Monday-Friday. JOB DESCRIPTION • A client of ours is looking for an analytical stability chemist to join their team in Florham Park, NJ. This person will be supporting the analytical department through method development, validation/transfer, while managing stability studies for all the brands/products within this company's umbrella. They will be responsible for routine analytical work (HPLC, GC instrumentation), protocol and report writing, and adapting methods for formulation or packaging changes. They will ensure stability compliance for both new and existing product/formulas. REQUIRED SKILLS AND EXPERIENCE -1-2 years of experience in a lab -BS degree in Chemistry, biochemistry, chemistry related -Experience working in a regulated lab; pharma or CPG -HPLC and/or GC experience -Wet chemistry experience NICE TO HAVE SKILLS AND EXPERIENCE -Experience in CPG (lotions, skincare) -Experience troubleshoot -Experience preparing technical documents -Experience in GMP environment

Our pharmaceutical client is looking for a chemist II to join their growing organization! If you are someone who wants to be a part of a highly technical team, this may be the role for you! The Chemist II/III will conduct release and stability testing for pharmaceutical products with specific focus on LC and GC chromatographic analyses as well as dissolution testing. This position involves conducting various analytical tests to ensure the quality and performance of solid dosage forms while maintaining a high level of laboratory safety and compliance. Key Responsibilities: • Prepare solid dosage samples for analysis by accurately weighing, blending, and homogenizing materials to ensure representative samples for testing., • Conduct dissolution testing of solid oral drug products using USP Apparatus I and Apparatus II., • Perform HPLC assays for the quantitative analysis of pharmaceutical components, including potency, purity, and samples from dissolution testing., • Ensure analytical instrumentation is properly maintained., • Ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs)., • Maintain accurate and detailed records of experiments, results, and procedures in laboratory notebooks and electronic systems, ensuring data integrity., • Adhere to safety protocols and participate in laboratory safety initiatives, ensuring a safe and compliant work environment. Minimum Qualifications: • Bachelor’s degree in chemistry with at least two (2) years of experience in the pharmaceutical industry., • Hands-on experience with HPLC, GC, Dissolution, and use of Empower software, • Strong analytical and problem-solving skills., • Excellent communication and teamwork skills., • Attention to detail and commitment to maintaining data integrity.

Service Technician/Engineer (M/W/D) For Mass Spectrometry/HPLC. Bring a passion for field service? Do you want to help customers on-site and be a trusted contact person? Do you want to use your knowledge and experience to help customers and Sciex develop a strong partnership?. Service Technician/Eng