Quality control analyst jobs in Pawtucket, RI

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

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 ******************.

We are seeking an enthusiastic Associate Synthetic Chemist to support the discovery of small molecules for next-generation 3D printing resins. You will work hands-on in the lab, executing syntheses of novel molecules, characterizing products, and exploring photochemical and photophysical structure-property relationships. This role is ideal for highly motivated early-career chemists who love synthesis and are excited to accelerate innovation through fast, iterative chemistry. You will be closely mentored by experienced synthetic chemists and will collaborate with analytical scientists and engineers developing our printing systems. Responsibilities Design, execute, and troubleshoot small molecule synthetic routes, with a focus on divergent or modular approaches to rapidly generate lead candidates. Purify products using chromatography and crystallization techniques. Characterize compounds via UPLC, NMR, UV/Vis and IR spectroscopy, and mass spectrometry. Work with cross-functional teammates to explore photochemical and photophysical structure-property relationships that drive 3D printing performance. Maintain excellent electronic lab notebook documentation. Contribute to management of chemical databases (e.g., commercial, proprietary, and virtual compound libraries). Minimum Qualifications Bachelor's degree in Chemistry or a closely related field with equivalent advanced chemistry coursework. ≥2 years of intensive organic synthesis laboratory experience (academic research and/or industrial roles). Experience with synthetic planning with chemical databases (e.g., SciFinder, Reaxys). Excellent command of synthetic and physical organic chemistry fundamentals. Experience with air-sensitive techniques (e.g., Schlenk line), purification (chromatography/crystallization), and data interpretation (NMR / LC-MS). Evidence of strong documentation and organizational skills, attention to detail, and the ability to manage multiple workflows efficiently. Evidence of strong collaboration and teamwork talents/skills. Ability to thrive in a fast-paced, collaborative R&D environment. Preferred Qualifications Command of the basics of photochemistry. Experience with heterocyclic and/or extended aromatic systems, especially those relevant to organic (opto)electronics. Benefits We offer competitive compensation packages in our VC-backed startup. Benefits include a full suite of offerings covering medical, dental, vision and 401k plan. Beautiful setting looking out over a river and seaport; outdoor seating and picnic areas. Highly collaborative work environment. Additional Information Travel: Occasional travel may be required from time to time Location: Boston, Massachusetts We value diversity in our company and are an Equal Opportunity Employer.

Prepare chemical solutions and maintain plating baths for electroplating operations. Operate and maintain electroplating equipment including tanks, rectifiers, and agitation systems. Calibrate and maintain laboratory instruments such as pH meters, spectrophotometers, and conductivity meters. Perform routine and specialized tests to monitor plating thickness, adhesion, and surface finish properties. Analyze chemical concentrations and adjust bath compositions to maintain optimal plating conditions. Document experimental procedures, results, and observations in lab notebooks and digital systems. Clearly and concisely communicate research to team lead and other team members. Collaborate with R&D teams to assist in research and development of new plating processes and surface treatments Collaborate with sales teams to troubleshoot customer plating issues. Ensure compliance with safety protocols, environmental regulations, and waste disposal procedures. Preferred: Experience with production-scale electroplating. Associate, Bachelor, or Master's degree in Chemistry, Chemical Engineering, Materials Science, or related field. 1+ years of experience in a chemical laboratory setting, with a focus on electroplating or surface finishing is a plus Strong understanding of electrochemical principles and electroplating chemistry (e.g., nickel, copper, silver, tin) is a plus Experience with a diverse range of analytical equipment, including UV-Vis, AA, SEM, XRF, XRD, wet chemical techniques, and surface analysis methods. Knowledge of ASTM and ISO standards and quality control procedures. Experience with corrosion science or surface science. Experience with Lean Six Sigma or certification. Qualifications: Strong bias for action and willing to go the extra mile Well-organized, detail-oriented, and results-driven team player. Methodical, proficient in data analysis, and excellent problem-solving skills. Ability to work both independently and as part of a multidisciplinary team. Familiarity with lab safety standards and chemical handling procedures

Contract Length: 6 month with potential extension About the Role We are seeking a highly motivated and independent QC Equipment Technician to be the operational and compliance expert for all laboratory equipment within our state-of-the-art biopharmaceutical Quality Control (QC) facilities. This specialized role is critical for ensuring the continuous qualification, calibration, and maintenance of high-precision analytical instrumentation, directly supporting the compliance and integrity of our clinical and commercial testing programs. Key Responsibilities The QC Equipment Technician manages the full lifecycle of laboratory assets and supports the robust quality system that governs their use: Equipment Lifecycle & Maintenance Coordinate and schedule calibration, maintenance, and Installation, Operational, Performance Qualification (IOPQ) activities with Facilities, Metrology, and QC end-users to minimize equipment downtime and address Out of Tolerance (OOT) events immediately. Monitor, coordinate, and communicate equipment lifecycle timelines-from acquisition and induction to qualification, implementation, and decommissioning-utilizing project management tools. Submit asset induction, work, and administrative requests to ensure equipment failures are addressed immediately and data in the Computerized Maintenance Management System (CMMS) is accurate and in the proper state. Serve as the primary QC point person for all equipment inquiries, acting as the liaison between the laboratory team and appropriate external vendors. Ensure all vendor representatives strictly follow site safety and cGMP procedures when working on equipment. Perform minor, non-invasive repairs on high-precision systems like UHPLC (e.g., changing capillaries, flow cells, needles/seats) and execute basic troubleshooting to diagnose complex failures. Quality & Compliance Documentation Support the authoring, review, and maintenance of high-stakes quality system records, including Deviations, Change Controls, and CAPAs (Corrective and Preventive Actions) as required. Author, revise, and maintain Equipment/Instrument Standard Operating Procedures (SOPs). Review preventative maintenance reports, calibration certifications, CMMS records, and perform system inventory audits to ensure compliance. Ensure all equipment documentation meets stringent cGMP, GDP (Good Documentation Practices), and data integrity requirements (ALCOA+) throughout its operational life. Ensure all tasks are performed in compliance with safety and cGMP requirements. Inventory & Logistics Order supplies and maintain inventory for equipment consumables and accessories. Assist with locating and collecting assets due for service and returning them to the laboratory promptly once service is complete. Basic Qualifications Education: Bachelor's degree (BS) in a relevant scientific discipline (e.g., Chemistry, Biology, Engineering, or related field). Experience: Minimum of 5 years of experience in a regulated laboratory setting with a BS degree. OR Minimum of 3+ years of experience in a GMP Quality Control (QC) laboratory setting. Knowledge: Demonstrated aptitude and ability to learn quickly to develop a strong understanding of GxP principles (cGMP, GLP). Skills: Proven expertise in laboratory equipment IOPQ, calibration, maintenance, and troubleshooting. Familiarity with electronic Quality Management Systems (eQMS) and CMMS software.

Location: Rochester MA (100% On-site), 1st shift only 6:30A-3:30P M-F, salary range $72K-$82K, full-time role: health insurance with an HRA, dental, vision, LTD, and a 401(k) retirement plan with an employer match. 3 weeks PTO, 1 week sick. Generous relocation package offered. Qualified candidates are encouraged to apply. Large precast concrete supplier in Massachusetts and New Hampshire, providing high-quality products for over 70 years. Their extensive product range includes septic tanks, manholes, drainage structures, bulkheads, curbing, residential steps, and retaining wall systems, all crafted to precise specifications. They cater to engineers, contractors, and homeowners, emphasizing superior performance and exceptional customer service. The Quality Control Technician (“QC Technician”) will work within the production plant and is ultimately responsible for product testing. The QC Tech will assist in the execution of quality control processes, procedures and protocol associated with the production of pre and post concrete pours. Responsibility Responsible for ACI concrete field tests Responsible for quality control inspections in manufacturing plant Inspect forms before pouring (Pre-Pour). Inspect product after removed from forms (Post-Pour) Notifies Production Supervisor if deficiencies are found. Perform and/or schedule repairs on products as needed. Housekeeping - maintain a clean work area. Including cleanliness within breakroom, restroom, and general facility areas. Expected to maintain knowledge of precast plant techniques and procedures. May assist with precast production operation as needed. Characteristics Always committed to safety. Maintain a safe work area. Follow safe work practices as outlined in the Safety Program. Always committed to quality. Follow and implement quality control measures. Excellent attendance. Reliable means of transportation to and from work. Ability to learn, organize and prioritize work and handle multiple tasks. Outstanding attitude, honesty, and ethic at all times. Expected to use sound judgment, diplomacy, and discretion. Work independently or cooperatively with others. Self-drive in carrying out the functions of the job. Requirements: ACI Concrete Field-Testing Grade 1 Certified (preferred) NPCA PQS Training Must be at least 18 years of age per federal guidelines. Good communication skills, both verbal and written to all levels of staff Ability to remain focused in busy environment. Computers and tablets skills in order to perform tasks. Ability to read blueprints and sketches.

Job Description About Us Stellar Industries is a rapidly growing industry leader in manufacturing metalized ceramics. We are a major supplier of innovative, high-quality parts to the Aerospace, Photonics, Telecommunications, and Commercial industries. The company was acquired by TRUMPF Photonics in 2019 and has significant growth goals. About the Role The Quality Control Inspector Level II maintains quality standards by inspecting incoming materials from outside suppliers, in-process production, and finished products in accordance with the quality standards and operating procedures set forth by the Head of Quality Control/Quality Assurance. What You Get to Do Works independently with minimal supervision. Maintain an organized and clean work area. Uses Hand tools, including but not limited to tweezers, calipers, and micrometers. Confirms specifications by conducting visual and measurement tests. Works with a variety of blueprints and technical drawings; must be able to interpret changing requirements as products and builds vary. Completes a General Inspection Report by documenting inspection findings regarding product dimensions, quantity of parts accepted/rejected, and basis of rejection. Uses Vision Systems and documents results into the computer. Follow all safety protocols. Cross-train as requested in other areas of the company. About You Minimum of 3 years of quality control experience. Must be able to work in a sitting position for up to 10 hours. Must be able to wear a lab coat, spittle mask, and gloves while working. The position requires working with measuring devices and microscopes. Individuals must have previous experience working in a similar environment. Must be able to work independently and demonstrate extremely high levels of precision and accuracy. line, High-Temperature BTU Furnaces, as well as various facility-related items, including air handlers, air compressors, air filtration units, etc. What We Offer Competitive pay A generous benefits package that includes medical, dental, 401K plan, and PTO Employer-paid vision plan, Employer paid Basic Life and AD&D Insurance, and Employer Paid Disability Insurance Tuition Reimbursement 4-Day workweek, Monday-Thursday 12 pm-10:30 pm Monday-Thursday 12:00 pm - 10:30 pm

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 **Qualifications** **Required:** + B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays + Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing + Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements) + Ensures inspection, testing and release timelines are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data + Experience using LIMS as an end user; Excellent technical writing and verbal communication skills + Must be capable of observing and adhering to lab safety standards and procedures + Successfully performs work independently with minimal instructions + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred:** + Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment + Experience in qualification of analytical equipment, including those with computerized systems + Experience in method validation/qualification/verification/transfer **Working Conditions:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + This is an on-site role working in a cGMP regulated manufacturing facility. **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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

Job Description Senior Scientist, Analytical Chemistry & Quality Control Salary: $100,000-$130,000 FLSA Status: Exempt We are on the search for a Senior Scientist to join our team at Pharmaron's manufacturing site in Coventry, RI. In this position, the Senior Scientist, Analytical will support process chemistry and manufacturing activities through analytical method development, optimization, validation, and transfer in compliance with all applicable guidelines. Primary Responsibilities: Develop, optimize and validate analytical methods that are GMP friendly based on quality-by-design and document formal protocols and reports. Participate in method transfer activities, including writing protocols and reports. Perform stability testing and data trending, as required. Review and Approval of Scientific Reports and SOPs. Manage analytical projects, coordinate analytical activities and ensure the project timelines are met. Implementing new analytical techniques and strategies to expand departmental capabilities. Solving multiple complex scientific problems. Ensuring adherence to GMP. Presenting and communicating clearly and effectively with clients. Experience and Education: PhD in Chemistry with 2 years of experience or MSc/BS in Chemistry or related field with 6 years of experience with the following instrumentation: HPLC, GC, NMR, FTIR, UV. Excellent communication skills, both verbal and written. Effective in managing multiple competing activities and delivering to timelines. Ability to work in a cross-functional environment. Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance preferred. High level of awareness of innovative technologies and ability to adapt to in-house needs. Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package, including: Medical, Dental & Vision Insurance with significant employer contributions. Employer-funded Health Reimbursement Account. Healthcare & Dependent Care Flexible Spending Accounts. 100% Employer-paid Employee Life and AD&D Insurance. Short- and Long-Term Disability Insurance. 401(k) plan with generous employer match. Access to an Employee Assistance Program. Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #ED-L1

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Sr. Scientist/Scientist II-II, Critical Reagents is responsible for overseeing all reference standards and other critical reagents in line with internal SOPs and ICH guidelines. This individual will work collaboratively with QC Operations, Analytical Development, and Quality Assurance in support of clinical pipeline and commercial products. This position requires strong leadership skills, statistical and technical knowledge, and a commitment to quality and compliance. The position will be hired at the Scientist II, Scientist III or Sr. Scientist level based upon the experience of the successful candidate. ESSENTIAL JOB FUNCTIONS Oversee the Critical Reagents and Materials function. Oversee the day-to-day operations of the GC QC Technical Services group. Provided operational oversight for critical reagent and materials management across the quality organization. Develop and maintain robust systems for the qualification, monitoring, tracking and storage of critical reagents and materials. Collaborate with cross-functional groups to ensure the continued supply of qualified reagents and materials. Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents and materials. Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials. Represent Quality Control on project teams and in meetings as required. Authors and reviews standard operating procedures, protocols, and reports as required. Manages the implementation/maintenance/continuous improvement of Quality Systems as required. SPECIAL JOB REQUIREMENTS Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired BS or MS in Life Sciences or Engineering Essential ON-THE-JOB EXPERIENCE 8+ years of pharma/biotech industry experience Essential Well versed in cGMP/ICH/FDA/EU regulations and guidelines Essential Large molecule, gene or cell therapy experience is required. Essential Expertise in reference standards programs, including ICH regulations and quality control methods. Essential Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents. Desired Experience in Quality Control within the biological pharmaceutical industry. Desired Proficiency in writing SOPs, qualifications protocols, and reports. Essential Familiarity with statistical software (JMP). Essential SKILLS / ABILITIES Excellent analytical and problem-solving skills Essential Must possess excellent communication and organizational skills Essential Cross functional collaboration ability to work well with diverse groups Essential Ability to manage multiple activities with challenging timelines Essential Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint) Essential Effective oral and written communication skills Essential Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards Essential Exhibits highest integrity and committed to ethics and compliance standards Essential Open and transparent in sharing data and information Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock Occasionally exposed to extremely loud noise levels Movement Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 25 pounds Occasionally lift and/or move up to 50 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail Pay Range: The annual salary range for this position is $100,000-$145,000. GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS Paid vacation days, amount based on tenure Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

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 $100,000.00-$120,000.00. 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 ***********

Title: Senior Scientist / Scientist, Quality Control Analytical Development Employment Type: Contract (6 months) Status: Accepting Candidates About the role This position supports QC Analytical Development through analytical method qualification, validation, and assay execution for biologic drug substances. The role partners closely with development and QC teams to advance methods into GMP testing environments. Key Responsibilities • Perform analytical method qualification and validation for biologics and process-related impurities. • Execute ELISA, qPCR, and potency assays supporting method lifecycle activities. • Support method development, transfer, and technology transfer into QC laboratories. • Prepare, review, and revise technical protocols, reports, and SOPs. • Collaborate cross-functionally with QC and development teams to ensure method readiness. • Provide training and technical guidance to team members when needed. Qualifications • Bachelor's degree with 8+ years, or Master's with 5+ years in Chemistry, Biology, or related field. • Hands-on experience with ELISA, qPCR, immunochemistry, and biologics analytical characterization. • Strong understanding of cGMP, pharmaceutical analytical development, and method lifecycle. • Experience with SoftMax and plate-based analytical systems. • Background with biologics, monoclonal antibodies, drug substances/products preferred. • Excellent documentation, communication, and organizational skills. Compensation (MA Pay Transparency): • Estimated hourly range (Senior Scientist): $55-$65/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.

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

Job Description Position: QC Scientist/Sr. Scientist (3rd shift, working hours: 11 pm- 7am), Quality Control & Analytical FLSA Status: Exempt We are on the search for a 3rd shift QC Scientist to join our QC team at Pharmaron's manufacturing site in Coventry, RI. In this position, the Scientist will support manufacturing and process chemistry activities through analytical method verification, optimization and sample testing in compliance with all applicable guidelines. Primary Responsibilities: Sample raw materials and conduct QC testing of raw materials, intermediates, API, IPC and cleaning verification samples following established procedures. Document and report results of all experiments in a timely-manner consistent with department practices and governing procedures, as applicable. Participate in method transfer or validation activities, including executing the protocols and preparing the reports. Review experimental data, notebooks, and instrument qualification protocols / reports. Write, revise, develop, and evaluate SOPs. Maintain good laboratory practices and GMP in compliance with safety and environmental requirements. Ability to work successfully in both a team/matrix environment as well as independently. Report lab event or deviation and participate in the investigation. Ensure high quality in QC and analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs. Provide training to other team members on instrument and testing method. Participate, support and facilitate site audits as directed and required. Perform other related assignments and duties as required and assigned. Experience and Education: BS in Chemistry with 3+ years of experience or MSc in Chemistry with 1+ year of experience. Have experience of using the following instrumentation: HPLC, GC, FTIR and KF. Ability to perform routine QC work independently or with less guidance. Excellent communication skills, both verbal and written. Effective in managing multiple competing activities and delivering to timelines. Ability to work in a cross-functional environment. Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance preferred. Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package, including: Medical, Dental & Vision Insurance with significant employer contributions. Employer-funded Health Reimbursement Account. Healthcare & Dependent Care Flexible Spending Accounts. 100% Employer-paid Employee Life and AD&D Insurance. Short- and Long-Term Disability Insurance. 401(k) plan with generous employer match. Access to an Employee Assistance Program. Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #IL-14

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: *****************************************************

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***********

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.