Quality control analyst jobs in Haverhill, MA

Title: QC Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This role supports real-time manufacturing operations by leading investigations, resolving on-floor issues, and ensuring high-quality documentation. You'll partner closely with manufacturing, QC, materials, and facilities teams to maintain operational continuity and compliance. Key Responsibilities • Triage manufacturing issues and lead analytical investigations and root cause analysis. • Write clear, compliant quality documentation including deviations and CAPAs. • Coordinate with SMEs to determine immediate actions, containment, and impact assessments. • Interpret data to support structured problem-solving and continuous improvement. • Provide technical operations support across manufacturing and QC functions. Qualifications • 6+ years pharmaceutical or biotech manufacturing experience. • 4+ years analytical investigation and QC-focused experience. • Strong background in RCA, deviation management, and GxP documentation. • Ability to interpret analytical data and think scientifically under time-sensitive conditions. • Experience partnering cross-functionally with manufacturing, QC, materials, and facilities teams. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$55/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results. Dismiss services promo card See curated AI tools for your job search

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role We are seeking a talented, collaborative, and highly motivated individual with expertise analytical methods highly focused on HPLC and QC operations to join our core team of scientists and engineers. The Senior Scientist will execute Quality Control testing, and associated operations and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market. Key Responsibilities Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing. Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows. Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing. Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues. Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review. Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions. Maintain rigorous laboratory documentation and complete, audit-ready analytical records. Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases. Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills. Qualifications Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience. Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation. Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance). Proven success developing and validating GMP analytical methods and supporting GMP operations. Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial. Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA+). Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously. Excellent oral and written communication skills. Commitment to collaborative work within interdisciplinary project teams. At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ******************.

A recognized pharma company is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA. is for candidates who are able to work on a W2 basis.** Responsibilities: Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance) Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc). Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods Perform other duties, as needed Qualifications: 5+ years of experience working in cGMP environment Bachelor's and/or Master's Degree in Analytical Chemistry, Biochemistry, Biophysics, or a related discipline Experience working in the cGMP QC lab of the Pharmaceutical or Biopharmaceutical industry Experience working with external contract labs (CMOs, CROs) Desired Skills: Experience analyzing Nucleic Acids, Virus Capsids, Antibodies, and/or other Biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications QC Microbiologist 5-8 years in biopharmaceutical setting , BS in Microbiology . QC Microbiologist requires: Proficiency in aseptic technique Endotoxin testing using Kinetic Methods Bioburden testing using membrane filtration methods Familiarity with general lab equipment Knowledge of cGMP requirements Must be able to perform lab bench testing QC Microbiologist duties: Performs traditional microbiology testing (Bioburden, endotoxin) in support of commercial product release testing Performs laboratory support functions such as review of data, maintenance of equipment and support of investigations May act as delegate /representative for QCM area on cross functional teams for investigations and continuous improvement projects Receives some supervision on routine work and instructions on new assignments. Organizes daily activities to ensure timely completion of assignments. Receives direction from scheduling. Reports on missed tasks Communicates straightforward This position will interact with peers of same or higher level QCM management and may interact with QA Additional Information $60HR 12 months

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: Develop/author/revise technical reports and laboratory procedures (SOPs, methods) Execute and troubleshoot raw material testing in support of production activities Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures Design and perform testing in support of method transfer/validation/qualification/verification Review/authorize data and perform analysis and interpretation of test results and trends Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration Support and mentor junior team members Collaborate with other network sites to share best practices Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description To provide technical, scientific and project support for the Quality Control- Technical Support team in establishing and monitoring testing procedures, investigations, technical transfer of methods, training of staff, and analysis of data and trends. PRIMARY RESPONSIBILITIES: 1. Provides technical support for method transfers, including protocol / report authoring and reviewing, data analysis. 2. Leads projects related to Quality Control programs as assigned. 3. Trains staff, monitors and oversees testing of Analytical Chemistry methods. In depth understanding of at least one discipline (cell based Bioassay, Immunoassay, Electrophoresis, Separation technology [chromatography]. 4. Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results. 5. Writes technical reports, reviews and revises standard operating procedures as needed. 6. Assists in troubleshooting laboratory equipment and procedures, taking required corrective action. Qualifications PREREQUISITES / QUALIFICATIONS: • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred • Minimum of 4 years of experience as a senior analyst in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory. • Strong technical experience with analytical methodologies. Perform troubleshooting of instrumentation and methods. Have ability to recognize instrumentation and method issues and provide recommendation on instrument and method improvements for the network. • Previous experience with method transfer desired. • Experience with LIMS and Smart lab computer applications a plus. • Proficient in common computer software applications. • Strong general laboratory and organizational skills, effective communication skills, both oral and written. • Strong attention to detail. Additional Information Regards _________________________________________________________________________________________________________ Ankit Gupta | Team Recruitment | Mindlance, Inc. | Office: ************ |

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions - together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. Duties and Responsibilities Laboratory role to support the qualification and validation of analytical methods for biologic drugs and process related impurities Primary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR Work collaboratively within a group of scientists to perform analytical method development qualification or validation under cGMP in collaboration with the Quality Control unit Apply expertise in molecular biology, cell biology and/or immunochemistry to analytical development team across the lifecycle of the procedures Participate in the technology transfer of analytical methods into QC and analytical method qualification Method transfer, method validation, method development Review & revise SOPs and/or author reports, protocols & other documentation as appropriate Collaborate with other labs to prepare methods for transfer to the QC GMP labs Provide training and work direction for group members as required Qualifications Bachelor's Degree in chemistry or a biological science with minimum of 8+ years of related experience (or master's degree with 5+ years of experience) in a cGMP environment Experience utilizing Spectramax M5 or M2 plate readers and the associated Softmax GMP software required Strong understanding of molecular biology assays in support of the product quality testing for Biologics drug substances/drug products Experience with analytical characterization of biologics is expected Strong organizational, time management skills, and prioritize work schedule to meet deadlines Must be able to communicate effectively with managers, peers, and clients Must demonstrate effectiveness in ability to train others as needed Strong knowledge and expertise of quality requirements pertinent to pharmaceutical AD labs Strong working knowledge of laboratory safety including standard precautions associated with hazardous & biohazardous material handling Experience with drug substance, drug products, intermediates, as well as experience with monoclonal antibodies is desired Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H) PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus Computer skills to include full competence with Microsoft Word, Power Point & Excel Working Conditions Laboratory environment working with chemical reagents and analytical equipment Normal office working conditions: computer, phone, files, fax, copier Personal Protective Equipment must be worn as required Minimum travel required Physical Requirements Frequent lifting up to 10 lbs.; frequent standing/walking Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods PPE as required ____________________________________________________________________________ Base Pay Range $52/hr - $67/hr

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description • This role will report to the Manager of QC Microbiology for support of product testing area. The candidate will support release testing for commercial, clinical and PV products. The candidate will support a variety of GMP activities in the QCM laboratory area. Analyst will be assigned testing roles via QCM standard work process • Performs traditional microbiology testing (Bio burden, endotoxin) in support of commercial product release testing • Performs laboratory support functions such as review of data, maintenance of equipment and support of investigations • May act as delegate /representative for QCM area on cross functional teams for investigations and continuous improvement projects • Receives some supervision on routine work and instructions on new assignments. • Organizes daily activities to ensure timely completion of assignments. Receives direction from scheduling. Reports on missed tasks • Communicates straightforward • This position will interact with peers of same or higher level QCM management and may interact with QA Qualifications • BS in Microbiology preferred • 5-8 years in biopharmaceutical setting preferred. • Proficiency in aseptic technique • Endotoxin testing using Kinetic Methods • Bio burden testing using membrane filtration methods • Familiarity with general lab equipment • Knowledge of cGMP requirements • Must be able to perform lab bench testing Additional Information Thanks and Regards, Karan Sharma 510-254-3300 ext. 150

Support raw material qualifications, method transfers, and validation of assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis and various HPLC methodologies (e.g. peptide map and carbohydrate analysis). Review compendial methods (USP, EP, JP) for alignment with internal raw material test procedures and specifications. Perform routine/non-routine data analysis calculations. Document analytical data under cGMP and corporate guidelines. Participate and resolve laboratory investigations of unexpected analytical results. Write/review SOPs, test methods, material specifications, validation protocols and reports. Support cGMP laboratory initiatives following laboratory SOPs. Other duties may be assigned. Qualifications Bachelor's degree in chemistry, biochemistry, or related scientific discipline required. Master's degree preferred. 6 years experience with a Bachelors or 4 years with a Masters Additional Information Interested candidates may contact at Praveen.arora at artechinfo.com or ************

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company. Schedule: Sunday - Wednesday 6:00AM - 4:30PM Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss Initiate the production of batch documentation used for engineering and cGMP production. Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes Complete executed Batch Records accurately and completely prior to submission to supervision for review Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Cross train to increase technical skills across the department Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements. As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed. Work with enabling groups to improve/implement processes. Other duties as assigned. Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 1-2 year's work experience in a GMP environment preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. #LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

The Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. The Senior Analyst, Quality Control Chemistry will support external laboratory testing and internal study protocol design, study report review and IND support as needed. This position will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to perform routine QC testing of in-process, DS, DP, and raw material samples. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs). Responsibilities: Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance) Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc.). Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed. Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods. Method Transfer / Validation of QC chemistry methods at internal and external laboratory. Model leadership behaviors and mentor/train junior staff The job responsibilities may change as needed to support activities relevant to the clinical phase. Requirements / Qualifications: BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment. Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must. Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred. Experience working with external contract labs (CMOs, CROs) is a plus. Strong collaboration and team-working skills. Strong communication, interpersonal and organizational skills. Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines. Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.

Sr. Scientist - FSP - Quality Control Shift: Full-Time; Monday - Friday; 8am-5pm EST ONSITE: This is a fully onsite role based at our customer's site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers' organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies. Key responsibilities: Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs Maintain accurate testing records and adhere to cGMP/GDP expectations May participate in executing method validations and/or method transfers Assist in troubleshooting of analytical methods with the assistance of manager when necessary May participates in author and review of data, SOPs, analytical methods, protocols and reports May participate in compliance related teams working towards the goal of continuous improvement. Report OOT/OOS results and other deviations to area management. Perform other laboratory duties as assigned. Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years') OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR PhD In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Understands cGMP concepts and general practices Knowledge and experience in chromatography, dissolution, and Karl Fisher Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance Strong attention to detail Demonstrate good communication skills both oral and written. A minimum of a Bachelor Degree in science or related discipline is required. Typically requires 4 years of experience in GMP pharmaceutical/biopharmaceutical industry Working Environment: Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in Massachusetts is $95,000.00-$110,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com) Job Summary The Quality Control (QC) Analyst will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. They will also participate in quality testing for ongoing customer stability studies and provide on-time, high quality results to meet Lonza's manufacturing demands. A QC Analyst applies job skills and company policies and procedures to complete a variety of tasks. They will work on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required and works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. 8 Hour Day Shifts: Monday through Friday Key Responsibilities * Running test samples for in-process, lot release and stability studies. * Reviewing assays. * Writing quality records (Deviations, CAPA, Change Control) and test methods. * Performs other duties as assigned. Key Requirements * Bachelor's or Associate's Degree preferably in Microbiology, Biochemistry, or related science discipline. * Use of Microsoft Suites (Word, Excel, PowerPoint). * Use of Laboratory computer systems. * Experience using GMP Quality Systems such as: TrackWise, LIMS preferred. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE · Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements. · Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring. · Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance. · Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations. · Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods. · Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed. · Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management. · Ability to prepare technical data and present to senior leadership. WHAT YOU WILL BRING · Bachelor's degree in Biology (Microbiology) · 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain). · Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing. · Excellent/Effective written and verbal communications skills. · Prepare technical data and present to senior leadership. · Escalate issues professionally and on a timely basis. OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE · Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements. · Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring. · Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance. · Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations. · Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods. · Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed. · Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management. · Ability to prepare technical data and present to senior leadership. WHAT YOU WILL BRING · Bachelor's degree in Biology (Microbiology) · 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain). · Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing. · Excellent/Effective written and verbal communications skills. · Prepare technical data and present to senior leadership. · Escalate issues professionally and on a timely basis. OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. Vaxess is a multi-disciplinary organization, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a skilled, collaborative, and highly motivated formulation technician with expertise in chemical, biotech, medical device or pharmaceutical manufacturing to join our growing team. The Formulation Technician will play a pivotal, hands-on role in meeting overall production goals by ensuring execution of formulation activities, while closely collaborating with cross-functional teams. Responsibilities Performs cGMP formulation operations according to documented procedures or batch records Operates formulation equipment such as fluid dispensers, mixers, pumps, and filtration systems Completes production batch records, logbooks, test records, and other documentation following Good Documentation Practices in a timely manner Performs in-process assays such as pH, density, filter integrity, and API concentration measurement Contributes to root cause analyses (RCA) and process development investigations Reviews and verifies documentation for completeness and compliance with regulatory standards Supports formulation related process development efforts as needed Adheres to all safety guidelines, including PPE usage, chemical handling, and emergency procedures. Performs other assigned duties related to manufacturing, facilities, and quality control as needed Qualifications 2 + years' relevant experience working in regulated environments in chemical, biotech, medical device or biopharmaceutical industries; experience working in a clean room is preferred High school diploma minimal, associate's degree or trade certifications preferred Strong laboratory techniques including pipetting, weighing, mixing solutions, aliquoting, and documentation Ability to work in a laboratory and clean room environment Good written and verbal communication skills, attention to detail, and a demonstrated ability to work independently as well as effectively within a team Entrepreneurial spirit and drive to positively impact global human health Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ******************.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Shift: Full-Time; Monday - Friday; 8am-5pm EST ONSITE/HYBRID: This is a fully onsite role based at our customer's site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Key responsibilities: Perform technical and quality reviews of internal and external documents, including raw data, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports and etc. Enter and trend stability data in SLIM system and generate stability timepoint summary reports. Establish/extend DS and DP shelf lives and generate shelf-life reports based on stability data. Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows. Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years') OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR PhD In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Proven Experience with stability studies, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports, including raw data and external documents. Stability data in SLIM system and generate stability timepoint summary reports. DS and DP shelf lives and generate shelf-life reports based on stability data. Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows. Attention to detail and ability to multitask, review tons of data. Working Environment: Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in Massachusetts is $90,000.00-$110,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description JobDescription: Skills: Must be detail-orientedand able to work with a high volume of documents in a fast-paced environment.Be highly organized and process-oriented. PreferredQualifications: Additional Information Best Regards, Sneha Shrivastava ***********