Quality control analyst jobs in Waltham, MA - 295 jobs

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.

Quality Control Analyst II Norton 45 per hour This is an onsite role in Norton, MA. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training. Perform routine and non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies in accordance with SOPs Support weekend laboratory operations and maintain required training records Assist with laboratory equipment and inventory maintenance, including reagent and sample preparation Review data in a timely manner and serve as a qualified data reviewer Perform operational assignments such as raw material processing, environmental monitoring, and in-process testing Contribute to the creation and updating of controlled documents, including SOPs, work instructions, and test methods Follow internal policies, SOPs, and applicable regulatory standards (GMP, GLP, ICH) Participate in continuous improvement initiatives and cross-functional collaboration Support regulatory submissions, inspection readiness, and audits Qualifications Bachelor's degree in Chemistry, Biology, Biochemistry, or a related field 4-8 years of pharmaceutical or biotech experience in GMP QC or equivalent environments Experience with method transfer and implementation; understanding of method lifecycle management preferred Strong technical writing, data analysis, problem-solving, and organizational skills Excellent communication and teamwork abilities Proficiency in LabWare LIMS, Microsoft Excel, Word, and PowerPoint preferred

A recognized pharma company is actively seeking a new Quality Control (QC) Analyst for a great entry-level position with their QC Bioassay group. In this role, the QC Analyst will be trained to perform cell-based bioassays, ELISAs, and other biological methods in a GMP-regulated setting, while also supporting external laboratory testing. Responsibilities: Learn and perform immunoassays (e.g., ELISA) and cell-based assays under supervision in a GMP environment to support product release and stability testing Assist in drafting and reviewing standard operating procedures (SOPs) and technical documents Support method transfer, qualification of critical reagents, and other assay-related activities Participate in the review and basic trending of QC data Assist with routine laboratory upkeep, including cell culture maintenance, instrument calibration, and inventory tracking Collaborate with internal teams and external partners as part of cross-functional project support Contribute to investigations and deviation reports under guidance Perform other duties, as needed Qualifications: Bachelor's Degree in Cell Biology, Molecular Biology, Biochemistry, or a related scientific field Familiarity with basic Lab techniques and Data Analysis methods Strong organizational, communication, and interpersonal skills Detail-oriented and eager to develop problem-solving skills in a regulated lab environment Enthusiasm for learning and the ability to work both independently and within a team Desired Skills: Academic or internship experience with Mammalian Cell Culture and/or ELISAs

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.

The Middlesex Corporation is a nationally recognized and award-winning leader in the heavy civil construction industry. Since 1972, the family business founded by Robert W. Pereira has developed an extensive client and project list through its consistent efforts to safely build America's infrastructure. The Middlesex Corporation specializes in building and reconstructing highways, bridges, marine, rail, and transit facilities through its collaborative team approach and focus on core values. In addition, Middlesex Asphalt in Central Florida is one of the largest and most productive asphalt plants in the United States with Middlesex Paving earning an equally solid regional presence and reputation. Position Summary: The MRM Quality Control Technician is responsible for ensuring the quality, consistency, and compliance of ready mixed concrete and aggregates produced by Massachusetts Ready Mix. This role performs routine plant and field testing, inspections, and documentation to verify materials meet applicable job specifications, Department of Transportation requirements, and industry standards. PIffd51030ed3e-37***********9

Quality Inspector III - Weekdays About Us Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, our client is reshaping how the world manufactures critical products. They build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through vertically integrated capabilities, including scalable additive manufacturing and precision machining, they deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Their team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. They foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because diverse perspectives lead to better outcomes. Job Purpose As a Quality Inspector III at our client, you will work in a diversified role within the Quality Inspection team dedicated to ensuring every product delivered meets the highest standards of precision, safety, and reliability. By applying expertise in inspection methods, quality systems, and problem-solving, this role safeguards customer trust, drives continuous improvement, and supports innovation in metal additive manufacturing. This position operates on the weekday shift: Monday-Friday, 6:00 AM to 2:30 PM. Key Responsibilities Perform First Article Inspections (FAI) and routine part inspections using calipers, micrometers, and other gauges. Verify that materials, equipment, processes, and products comply with quality specifications. Develop and validate inspection and test methods; assist in creating SOPs and inspection protocols. Monitor, analyze, and report on product quality metrics. Support compliance with customer, internal, and industry requirements (AS9100, ISO 9001, ISO 13485) through audits and gap analysis. Assist in developing and implementing process controls, corrective actions, and continuous improvement initiatives. Ensure workflows, processes, and products comply with safety regulations. Investigate and troubleshoot product or production issues. Inspect manufactured parts, issue non-conformance reports, and facilitate MRB hardware disposition and corrective action tasks. Work independently and manage daily priorities with minimal supervision. Communicate and collaborate with operations personnel to ensure production needs are met. Initiate and communicate identified nonconformances. Qualifications 5+ years of experience performing part inspections with strong drawing interpretation skills. Extensive knowledge of GD&T principles. Experience with First Article Inspections (FAI), Test Method Validation (TMV), and developing inspection methods. Proficiency in AQL sampling techniques. Skilled in performing dimensional and visual inspections. Experience with root cause analysis, data analysis, and troubleshooting. Experience in medical device, aerospace, or defense manufacturing required. Hands-on experience with advanced inspection equipment and software, including CMMs, PCMMs, vision systems, profilometers, and blue-light scanners (e.g., Zeiss, Faro, Keyence). Ability to troubleshoot issues encountered with inspection equipment. Self-motivated, hands-on team player with excellent communication skills; adaptable to fast-paced environments and excited by new challenges in metal additive manufacturing.

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

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You'll Do: The Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs) Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards Perform detailed review and provide data integrity oversight of data generated at CDMOs Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements Oversee stability programs to support product retest, shelf-life, and expiration dating Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs) Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.) Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing Provide technical guidance and support to internal teams and external partners Oversee the preparation and review of technical documents, including protocols, reports, and SOPs Ensure data integrity and traceability in all analytical documentation Required Qualifications: PhD with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 years of experience in analytical development and quality control within the pharmaceutical or biotech industry Proven experience with peptides and small molecules in both injectable and solid oral dosage forms Experience managing outsourced activities with CDMOs Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development Proven effective communication and interpersonal skills Ability to work effectively in a fast-paced, collaborative environment Preferred Qualifications: Experience with combination drug/device presentations is preferred Experience with establishing peptide drug substance analytical control strategy for various peptide synthesis modalities (linear SPPS, hybrid approaches, LPPS, and/or recombinant) is preferred Education: PhD or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience Salary Range $115,000 - $140,000 USD For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances. E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. #LI-Hybrid

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: ************ |

About the Role The Small-Scale Cell Culture Scientist is a hands-on technical contributor in the Bioprocess Design Center (BDC), responsible for designing, executing, and documenting upstream cell culture experiments that generate high-quality technical evidence for Thermo Fisher Scientific's single-use bioprocessing technologies. This role operates at the intersection of experimental biology and systems-level process design. The successful candidate will independently own small-scale cell culture studies, translate experimental outcomes into actionable insights, and support integrated workflow development across upstream unit operations. While primarily lab-focused, the role requires strong communication skills and comfort engaging with cross-functional partners and customers. Location: This is an onsite position in Plainville, Massachusetts. Residency within commuting distance is required. No relocation assistance will be provided. Key Responsibilities Experimental Design & Execution Independently design and execute small-scale upstream cell culture experiments (typically 2L-50L) using single-use bioreactor systems. Incorporate process analytical techniques (PAT), online sensors, and at-line/off-line analytics to monitor and assess cell culture performance. Execute mammalian cell culture processes such as fed-batch and intensified workflows, ensuring reproducibility, data integrity, and traceability. Troubleshoot experimental and data-related issues, including sensor performance, data quality, and process variability. Systems, Automation & PAT enablement Analyze experimental datasets using advanced data analytics approaches, including multivariate analysis, trend analysis, and statistical methods, as appropriate. Leverage JUMP™ and other analytical programs to support data-driven decision making and improve experimental efficiency. Translate complex datasets into clear, defensible conclusions and visual summaries suitable for internal and customer-facing audiences. Author protocols, technical reports, summaries, and SOPs that integrate experimental outcomes with process data insights. Data Analysis & Digital Enablement Analyze experimental datasets using advanced data analytics approaches, including multivariate analysis, trend analysis, and statistical methods, as appropriate. Leverage JUMP™ and other analytical programs to support data-driven decision making and improve experimental efficiency. Translate complex datasets into clear, defensible conclusions and visual summaries suitable for internal and customer-facing audiences. Author protocols, technical reports, summaries, and SOPs that integrate experimental outcomes with process data insights. Collaboration & Communication Collaborate closely with engineers, scientists, and cross-functional teams to align experimental work with BDC priorities. Support customer visits, technical demonstrations, and internal reviews by clearly explaining experimental intent and results. Communicate progress, risks, and outcomes effectively to technical and non-technical audiences. Laboratory Operations & Compliance Maintain a safe, compliant, and organized laboratory environment. Follow applicable safety, quality, and data integrity requirements. Contribute to continuous improvement of lab workflows and experimental practices. Qualifications Education B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, Bioengineering, or a related field with 3+ years of relevant experience M.S. with 2+ years of relevant experience Equivalent combinations of education and experience will be considered Experience & Skills Hands-on experience with mammalian cell culture and upstream bioprocessing Familiarity with single-use bioreactor systems and small-scale process development Experience designing and executing controlled experiments; DOE experience preferred Strong data analysis, documentation, and technical writing skills Working knowledge of GLP/GMP concepts and laboratory best practices Proficiency with standard data analysis and reporting tools (e.g., Excel, PowerPoint) Preferred Attributes Demonstrated ability to work independently in a fast-paced, matrixed environment Strong problem-solving skills and attention to detail Ability to translate experimental data into practical insights Comfortable operating in environments with evolving requirements and priorities Collaborative mindset with a customer-centric orientation Physical Requirements Ability to work in a laboratory environment and handle light to moderate lifting (up to ~50 lbs) Standing and walking for extended periods during experimental execution Manual dexterity to operate laboratory equipment and instrumentation Why Join the Bioprocess Design Center The BDC is where Thermo Fisher technologies are stress-tested, validated, and transformed into real-world solutions for our customers. This role offers the opportunity to work hands-on with cutting-edge single-use systems, contribute to evidence that shapes customer confidence, and grow within a technically rigorous, highly collaborative environment. Compensation and Benefits The salary range estimated for this position based in Massachusetts is $96,000.00-$127,000.00. 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: *****************************************************

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

Piper Health & Sciences is seeking a full-time iPSC Production Scientist to join a growing organization's Bio/Engineering Production team onsite at their Massachusetts location. The ideal candidate will have a strong biology background and hands-on experience in iPSC stem cell culture, differentiation, and QC within a pharmaceutical or biotech environment. Responsibilities of the iPSC Production Scientist Include: * Full-time onsite schedule: Monday-Friday, 9:00 AM - 5:00 PM * Lead and support iPSC production and related lab activities * Perform hands-on stem cell culture and differentiation * Execute QC-related tasks in accordance with SOPs * Maintain accurate lab documentation and records * Support Bio/Engineering Production workflows * Follow all safety, GMP, and GLP standards Qualifications of the iPSC Production Scientist Include: * Biology degree is strongly preferred (Biomedical Engineering degrees are NOT a fit) * Proven hands-on experience with: * iPSC cell culture * Stem cell differentiation * Quality Control (QC) processes * Pharmaceutical or biotech industry experience preferred Compensation of the iPSC Production Scientist Includes: * Salary Range: $83,200.00 - $114,000.00 per year (equivalent to $40.00 - $55.00 per hour), based on experience and certifications. * Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401k through ADP and sick leave as required by law. * Ability to work with a well renowned and growing organization that has a robust pipeline and quality culture. This job opens for applications on 1/12/2026. Applications for this job will be accepted for at least 30 days from the posting date. #LI-AW1 #LI-ONSITE keywords: Scientist, iPSC Production, stem cell culture, induced pluripotent stem cells, cell differentiation, quality control, QC, laboratory scientist, cell biology, biotechnology, pharmaceutical production, bioengineering, GMP, GLP, SOP compliance, tissue engineering, regenerative medicine, bioprocessing, cell therapy, stem cell research, lab operations, onsite scientist, Medford MA jobs, contract scientist, PhD biology, master's biology, postdoctoral research, biotech scientist, pharma scientist, cell culture specialist, stem cell specialist, iPSC scientist, QC scientist, bio production scientist, laboratory techniques, cell-based assays, biotech careers, pharma careers, stem cell manufacturing, cell culture workflows, life sciences jobs, biopharma jobs, laboratory compliance, scientific documentation, biotech industry experience, pharmaceutical industry experience, cell line development, research scientist, production scientist, laboratory QC, stem cell differentiation protocols, cell culture maintenance, full-time onsite scientist, bioengineering production team, regenerative biology, tissue culture, cell therapy manufacturing, biotechnology research, pharmaceutical QC, biomanufacturing, cell biology techniques, stem cell QC testing, scientific method, laboratory safety standards, GMP compliance, GLP compliance, biotech contract role, scientist contract position, iPSC culturing, stem cell production, biotech Medford MA, pharma Medford MA, scientific careers, laboratory scientist jobs, cell therapy scientist, bioprocess scientist, QC laboratory scientist, stem cell lab work, biotech production workflows, pharmaceutical production workflows, life sciences contract jobs, biotech contract scientist, pharma contract scientist.

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.

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 ***********

We are seeking an experienced Quality Control Technician with proven leadership skills and a devoted work ethic who is looking for a successful career and the opportunity to grow with The Middlesex Corporation, a rapidly growing, successful, and well-established heavy civil infrastructure company. As a Quality Control Technician, you will play a critical role in the overall leadership and successful and timely delivery of complex multimillion-dollar fast-track, complex heavy-civil, highway, and bridge projects from the pre-construction stage through project execution and completion. Responsibilities: Comply with and actively promote all Safety policies and procedures, including reporting accidents, incidents, and near-misses to uphold the company's core value of "Safety first." Actively participate in overall day-to-day operational leadership and decision-making as the subject matter expert for all project quality management functions, including self-performed work, materials, or work performed by suppliers, vendors, subcontractors. Provide ongoing and regular quality control-related technical input for construction planning, interpretation of design, development of efficient construction methods, and quality control processes for execution of the work. Manage and schedule all required quality testing, inspections and documentation including all third-party quality control related services. Manage the quality processes required per contract documents, specifications, drawings, engineering calcs for work activities such as crane/hoisting lifts, temporary works, falsework, shoring, formwork, safety systems, etc. Provide overall leadership to ensure work is constructed in compliance and work quality is accurately documented through clear and traceable record keeping and reporting. Develop and implement project specific Quality Control Plan that meets company policies, project requirements and is aligned with industry standards and best practices. Perform periodic audits to verify adherence to QA/QC Management Plan. Develop a comprehensive working knowledge of project contract documents, (drawings and specifications, and requirements by reference, etc. Maintain applicable industry reference standards and facilitate project access to relevant team members. Develop and implement a project Quality Control orientation program to ensure project team members are familiar with the requirements of the project QC Management Plan, and conduct to relevant project specific training, relative to Quality Control roles, responsibilities, processes, and procedures. Contribute to interpretation and dissemination and communication of project quality control requirements to relevant, staff including field crews and craft supervision. Assist in document management to ensure all project documents are updated and current to reflect any changes, revisions, etc. Assist in the procurement, buy-out, and management of subcontractors, suppliers/vendors to ensure subcontract /vendor agreements capture required quality related scope of work. Prepare and submit accurate Quality Control project status project reports. Manage project submittal process to ensure timely receipt, review and approval of submittals and shop drawings, as-builts, and other required documentation. Actively participate in RFI process to ensure timely receipt, review, response close out. Monitor project work for any non-compliance issues and ensure corrective measures are approved, executed and closed out with documented acceptance. Manage project close-out including, timely management of punch list, commissioning, and transitional system operations turnover. Qualifications: Four-year engineering or construction management degree or equivalent combination of technical training and relevant experience. Minimum of two (2) years of documented experience performing in a construction quality control management role on a heavy civil construction rail project. Comprehensive understanding of construction industry practices and standards, as well as experience with supervision, estimating, scheduling, budget preparation, and project status reporting. Experience utilizing project management software systems. Currently possess or can attain the NETTCP Quality Assurance Technologist and USACE Construction Quality Manager Certification. Heavy-Civil construction experience. PI964e8016bac9-37***********2

Title: QC Specialist - Chemistry Employment Type: Contract Status: Accepting Candidates About the role This role supports Quality Control Chemistry operations by leading QC Sample Management activities across multiple lab functions. You will ensure compliant, on-time sample processing while partnering with digital and quality teams in a fast-paced cGMP environment. Shift: Wednesday-Saturday, 6:00 AM-4:00 PM. Key Responsibilities • Lead QC Sample Management operations supporting Chemistry, Microbiology, Bioassay, and Raw Materials • Oversee daily schedules to ensure compliant sample processing and documentation • Author and maintain SOPs, deviations, CAPAs, and change controls • Act as primary support for audit readiness and regulatory inspections • Partner with Digital teams to optimize LIMS (LabVantage) and data workflows • Manage CTU systems, investigations, and compliance issue resolution Qualifications • BA/BS with 3-5 years or MS with 1-3 years of cGMP Quality Control experience • Strong hands-on experience with QC Sample Management • Proficiency with LIMS and Veeva Quality Systems • Working knowledge of FDA, EU, and ICH regulations • Experience with gowning, aseptic technique, and lab safety practices • Proven people management and cross-functional leadership skills Compensation (MA Pay Transparency): • Estimated hourly range: $40-$45/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

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