Quality control analyst jobs in Durham, NC - 291 jobs

We are seeking highly professional and skilled Spray Technicians. The Spray Technician will be responsible for delivering and maintaining a healthy dynamic appearance for a variety of turf, shrubs, and trees at different locations. What would my responsibilities be? Perform chemical and fertilizer applications on assigned high-profile properties. Scout properties beyond assigned needs for any issues. Report to Manager for direction to treat while on-site or future scheduling. Complete a pre-trip inspection report on vehicle, trailers, and equipment daily. Contribute to our safety culture by attending and actively participating in weekly safety trainings. Follow company safety protocols, identify, and communicate safety issues to the team. Why Join Yellowstone? Competitive hourly pay, paid weekly Benefits package including health, dental and vision insurance, 401k with a company match Industry-leading safety programs Company provided safety gear Equipped with optimal and most professional equipment High profile customers, worksites, and landscape results -A company that values and appreciates YOU Requirements Legal authorization to work in the United States Ability to diagnose insect, disease, and weed issues in the field. One year of experience in fertilization and chemicals Must have reliable transportation to the Branch or first job site Safe driving record and ability to successfully pass a Motor Vehicle Report ("MVR") required Strong English communication skills. Spanish a plus Become part of the team dedicated to Excellence in Commercial Landscaping

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The QC specialist I Raw Material Specifications and Vendor Change Notifications (VCN) will provide Quality Control Support for all KBI US based sites. This support will primarily include routine cGMP operations related to the authoring of material specifications for raw materials and consumables as well as performing impact assessments to raw materials and consumables stemming from Vendor Change Notifications (VCN). The incumbent will perform daily activities to assure timely development of raw material specifications, change control management, and the material readiness program to support project timelines. This includes coordination with approved third-party laboratories and internal testing teams to ensure the appropriate methods are listed on the material specification as well as determination of the appropriate sampling amounts to complete all testing. The QC Specialist I Raw Material Specifications and Vendor Change Notifications provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Additionally, this position acts as QCRM support for internal and external audits as well as working with clients on material specification development. Responsibilities: · Draft specifications for raw materials and consumables and/or draft assessments for VCNs. · Perform change control activities to ensure material specifications are drafted/updated in accordance with established timelines. · Interface with internal and external customers to support client audits and regulatory inspections as required. · Interface with client regarding material specification inquiries. · Support relevant investigations, change controls, CAPAs, and QC-related projects. · Attend relevant operational meetings in support of all activities related to timely establishment of material specifications for raw materials and consumables as well as responses to VCN Requirements: · Education: Bachelors degree in a scientific discipline or related field with 2+ years of experience or Associates Degree in a scientific discipline or related field with 4+ years of experience. Commensurate experience in regulated industry with strong understanding of compendial requirements, analytical testing, and change control may be considered in lieu of the specified education requirements. · Technical skills/Abilitites Demonstrated interpersonal skills, ability to work in a team environment, high attention to detail, and strong problem resolution skills are critical for success in this position. A strong understanding and ability to interpret US, EU, and other regulatory agencies' CGMP compendia and guidelines is necessary for the incumbent. Additionally, exceptional technical writing skills and understanding of regulatory testing requirements and the ability to understand impact due to changes in vendor processes for raw materials and consumables is required for this role. · Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations in English. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. · Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. · Math Aptitude Basic math skills are required. Ability to apply concepts of basic algebra and statistics. · Computer Skills Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, Virtual chat, and meeting platform (such as Microsoft Teams). Ability to use Business related software systems (such as SAP). Salary Range: $55,000 - $75,900 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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 To support functions of the Sample Management group as assigned. Major Accountabilities Support functions of the QC Sample Management group as assigned, including, one or more of the following: Assist in response to BAS alarms and documentation in AIM's system, including root cause determination and resolution Assist in the coordination and scheduling of all QCSM equipment PM's and CM's Assist in distribution of all samples destined for various QC labs on 24/7 basis (Bulk, CV, FIO, Fill Finish, MF59, EM/UM, TD special projects, etc). Total QCSM throughput averages over 800 samples per month and is forecasted to increase Support shipping of QC samples Support sampling activities in a bio safety cabinet Support for timely and effective investigation of area DR's Support inventory control of all retain, reference and reserve samples Responsible for ordering and inventory control for glassware and sterile supply to the various QC labs Support entering all required data into LIMS (materials, projects, products, testing) Specific training requirements to be determined by functional manager depending on activities assigned. Skills: 0-3 years industry experience in one or more of the following: GMPdocumentation in a production environment Conducting and documenting investigations Use of electronic document management systems Use of Atlas document management system or equivalent Sample collection/distribution/testing/shipment Material receipt/testing Glass washing activities and restocking of supplies Qualifications BS degree in sciences, preferably Biology or Chemistry, or other related scientific field Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

The QC Microbiology Analyst 1 role is responsible for microbiological testing. -Testing of finished product samples, stability samples, and special test requests of multiple products per standard operating procedures. -Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements. -Ensures review of laboratory testing is done in compliance with SOPs and is completed in an accurate and timely manner. -Maintains compliance with SOPs, GLP, GMP, and HSE requirements. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements -Bachelor's Degree in Microbiology, Biology, Biochemistry or science related!

Kincell Bio engineers cells into therapies . With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at ******************* Quality Control Analyst I will primarily be responsible for supporting late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. As part of the Quality operations, you will initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Actively participates in fostering a positive, collaborative work culture. Authoring and revision of standard operating procedures, test methods, protocols, and reports Participate in executing raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations. Testing of material utilizing methods such as pH, Osmolality, Appearance, cell culture, bacterial endotoxin, dPCR, ELISA, and other assays used for release and characterization of products. Data analysis and review Initiate and participate in laboratory investigations, including deviations and out-of-specifications. Perform equipment calibrations and analysis of cell viability. Participate in the execution of method and equipment troubleshooting and optimization. Maintain documentation in accordance with GDP. Other duties as assigned. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. B.S. degree in science or a life science-related field of study Experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory, is preferred. Experience with the following instrumentation: Flow Cytometer (i.e., NC-200), Cell Counter (i.e., NC-200), Hematology Analyzer, Ella Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances) An equivalent combination of education and experience may be considered. Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH) Involvement in continuous improvement initiatives and laboratory investigations Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable. Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH) Proficiency in Microsoft Office suite applications. Detail-oriented and highly motivated with excellent written and verbal communication skills required. Ability to work independently and stay on task in a fast-paced environment without direct supervision. Ability to function in a rapidly changing environment and balance multiple priorities simultaneously. Physical Demands Adjusting or moving objects weighing up to 25lbs Travel Requirements 10% Location This is a site-based position located in Durham, NC , and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends. #LI-Onsite Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.

The Scientist 2, QC Analytical Development (AD) Chemistry is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. The QC AD Chemistry Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (ic IEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria. * Relevant experience in analytical method development and validation. * Demonstrated application and knowledge of ICH guidelines on analytical method validation. * Experience with customers and analytical method transfers. * Experience with project management and demonstrated ability to monitor project progress and provide status updates. * Demonstrated communication skills, technical proficiency, scientific creativity, collaboration with others and independent thought. * Planning of projects in terms of timing, execution of deliverables and resource allocation. * Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities. * Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and SmartSheet. * Familiarity with LIMS Software. * Proficient in physical and chemical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (ic IEF)), wet chemistry sub-visible particle analysis, and glycan analysis, and peptide mapping. * Displays an advanced knowledge of GMP requirements for laboratory operations. * Possesses a broad knowledge of quality control operations, systems, and directives. Minimum Qualifications * Bachelor's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of analytical laboratory experience preferably in Biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO). * 4-6 years of experience in a GMP environment Preferred Qualifications * Master's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7+ years of experience; OR, * Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience. * Experience with Customer Relationship Management. * Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting. * Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system). Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: * Will work in environment which may necessitate respiratory protection * Ability to discern audible cues. * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. * Ability to stand for prolonged periods of time up to 120 minutes * Ability to sit for prolonged periods of time up to 120 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. * Ability to conduct work that includes moving objects up to 10 pounds. * Will work in warm/cold environments. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. * LI-Onsite EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Job Title: Quality Control AnalystJob Description As a Quality Control Analyst, you will be primarily responsible for performing tasks associated with release testing and reviewing laboratory data. This role requires ensuring samples are collected, tested, and reviewed according to quality requirements, ensuring results are valid, accurate, and documented in line with regulatory and corporate standards. Responsibilities * Perform testing and associated tasks without errors according to applicable SOPs and protocols within the Immunology/Biochemistry function. * Properly document test results in appropriate records and computer systems. * Comply with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements. * Participate in lean lab operation, 6S laboratory layout, preventive action, and continuous improvement programs to reduce operating costs. * Engage in cross-training to support staff availability within the QC department. * Develop expertise in assigned assays and techniques. * Perform additional shift work as required to support operations. Essential Skills * Bachelor's degree in Biochemistry or related field. * 1+ years of laboratory experience. * Knowledge of analytical methods and related instrumentation. Additional Skills & Qualifications * Experience with GMPs safety regulations and data integrity. * Experience in performing basic biochemistry/molecular biology-based assays such as ELISA, BCA, SRID, and SDS-PAGE. * Knowledge of aseptic technique. * GLIMS experience. Work Environment The position operates within an Immunology/Biochemistry lab setting. The work schedule follows standard business hours, Monday through Friday, from 8 am to 5 pm. Job Type & Location This is a Contract position based out of Holly Springs, NC. Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Holly Springs,NC. Application Deadline This position is anticipated to close on Jan 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Quality Control Specialist is an entry level opportunity within the Quality Control organization at AskBio. This individual will perform routine GMP testing activities in a regulated gene therapy manufacturing environment. This position is responsible for analytical testing using established methods, preparing reagents and solutions, and supporting the maintenance of cell lines used across multiple clinical programs. The QC Specialist plays a critical role in ensuring data integrity, compliance and operational excellence within the QC laboratories. The Quality Control Specialist, reporting to the Manager of Quality Control, will be an office-based position in RTP, NC. Job Responsibilities Perform routine analytical testing including but not limited to cell-based potency assays, dd PCR, qPCR, ELISAs, limit tests using HPLC techniques Prepare solutions and maintain cell lines for various clinical programs Prepare laboratory solutions, maintains cell lines, and other day to day laboratory activities Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records Assist with management of analytical test method supplies and samples as needed Ensure lab areas are clean and organized, maintaining equipment and consumables Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external Participate in continuous improvement projects in the AD and QC labs Support revisions to work instructions, SOPs, forms, protocols, and reports Minimum Requirements Bachelor's degree in biology or related field Excellent verbal and written communication skills Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team Ability to handle multiple projects/teams simultaneously Ability to work independently in a fast-paced, highly interactive environment with minimal supervision Preferred Education, Experience and Skills Relevant work experience in cGMP regulated Quality Control laboratory Experience working for a pharmaceutical or biotech company GDP experience Experience with cell-based assays and PCR testing Experience working within a cGMP Quality Control LIMS system AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

Conducts various quality control activities and assists with the application and monitoring of established inspection procedures and methods. Inspect and evaluate received/installed equipment and materials to ensure the highest level of quality for final products. Responsible for rejecting items that do not meet specifications and/or company established quality standards. Be familiar with various types of testing equipment and how to interpret results. Key Responsibilities: QA responsibilities: Review and understand job specifications for Quality related scopes Review and understand job drawings (flow diagrams, boundaries, etc…) Review and understand job submittals Implement QC Plan for specific project QC responsibilities: Perform receiving inspections of material and equipment Verify component verification of major equipment per approved submittal Witness company welding quality assurance procedure is being implemented including current weld documentation (IE: WPS, PQR, Weld Log, Weld Travelers, Weld Stamps) Overseeing the installation of all mechanical scopes including sub-contract work Verify all mechanical testing, flushing and cleaning is executed per contract documents Implement non-conformance and corrective actions program Maintain turn over documentation throughout project in hard and digital formats Commissioning responsibilities (when applicable): Witness Factory Acceptance Testing on required Mechanical equipment Coordinate Pipe flushing, cleaning disinfecting (sometimes with 3rd party vendor) Coordinate Mechanical Start-up activities with supplying vendors and or qualified technicians Coordinate Commissioning activities with (3rd party) Cx group, company support, client and other sub-contractors Education: A minimum of a two (2) year business, construction management or mechanical engineering degree Certified Welding Inspector (CWI) qualification is desirable Hands-on or on-the-job training is available when necessary as well as continued education training. Job Requirements/Special Skills: Good Documentation Practices (GDP) Ability to read/interpret isometric drawings, schematics and flow diagrams Familiar with various types of testing equipment Good digital and verbal communication skills with employees, clients and other contractors Professional and positive attitude Open minded with a vision for continuous improvement Ability to take on more responsibility as the business grows. Computer programs (Word, Excel, BIM, Bluebeam, Gmail & Cloud-based servers) Quick to understand new procedures Ability to be flexible in work hours due to after hours testing sometimes required.

Perform all inspections and functional testing on all manufactured generator systems to ensure that the gear meets necessary electrical code, that the gear functions as designed by the specified engineer, and that the gear is safe to be energized on-site before it leaves the manufacturing plant. Qualification Requirements Must be able to reliably work an eight-hour minimum shift with some voluntary exceptions. To perform this job successfully, an individual must be able to perform each essential procedure safely and thoroughly. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Functions + Locate and keep track of documentation for specific jobs. + Run procedural tests and inspections in an organized format complying with necessary functions for gear types. + Load files and test sequence of operations as dictated in project CD set notes. + Accurately record test results and component specs. + Move gear with use of forklift or pallet jack. + Removal and reinstallation of panels up to 50 lb. + Other duties as assigned. Minimum Qualifications + High school diploma, equivalent, or higher degree (Relative work experience will be considered). + NFPA70E is required (Can be provided by PowerSecure if other requirements are satisfactory). + Ability to read and interpret documents such as safety rules, operations manual, and written directions in the English language. + Ability to follow report guidelines to accurately document test results and product specifications. + Ability to add, subtract, multiply, and divide in all units of measure in order to determine splice plate length and basic voltage and amperage measurement ratios. + Ability to wear and maintain proper PPE. + Minimum of 2 years' experience working with Switchgear, Electrical, or Generator systems (unless applying for an apprenticeship position). + Engineering or programming experience will be accepted in lieu of Switchgear, Electrical or Generator experience. Knowledge, Skills and Abilities + Knowledge of diesel engines. + Understanding of electrical schematics and ability to interpret mechanical notes. + Through accumulated experience, must be able to quickly and effectively diagnose and repair nonconforming electrical circuits. + Excellent verbal and written communication skills required. Physical Demands + Limited local travel will be required. Less than 10% + Must be able to work in confined spaces and to position one's self in various positions including low to the ground or high up on equipment. + Must be able to lift 50lbs and manipulate heavy test equipment and cables. + Manual dexterity to operate digital equipment, including computers and PLC's, protective relays, controllers, and other such equipment with + small fine buttons and operators. + Must be able to work outside for extended periods of time Work Environment When running the engines, you will be working outdoors with exposure to the elements. This can include, but is not limited to, heat, cold, or rain. A risk of electrical shock is always present. At times there can be hazards from moving equipment (i.e.: forklifts). There can be a lot of ambient noise, and in some cases hearing protection must be worn. Risk of cuts or abrasions is present, especially when dealing with panels, or maneuvering between units for splice plate measurements or mechanical checks. About Us PowerSecure, a Southern Company subsidiary, is a leading provider of innovative energy solutions to electric utilities and their industrial, institutional, and commercial customers. Join Our Power Team! (https://cloud.3dissue.com/***********37/242401/HR-9-14-2020/index.html) We invest in high-value and cost-effective benefits for our employees. Our benefits package includes: + Medical, dental, vision and life insurance coverage + Competitive pay and a matching 401 (k) plan + Vacation, Company Holidays, Paid Time Off (PTO- personal and sick days) + Flexible spending accounts/Health savings account + Wellness Incentive Programs + Employee Referral Program + Tuition Reimbursement PowerSecure is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. This position is not open to third party recruiters. #ZR Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor.Operating Company: PowerSecure

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 **************** . **Purpose and Scope:** The **Specialist, Quality Assurance for QC** will be responsible for providing direct Quality oversight and support for Quality Control and US Methods and Tech Transfer laboratory operations and method qualification activities. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This role will collaborate with cross-functional teams such as other Quality Assurance, Validation, Manufacturing, and MSAT teams to ensure quality and compliance. **Essential Job Responsibilities:** **Quality Oversight of Laboratory Operations:** + Provide QA oversight of QC laboratory activities, including testing of raw materials, in-process samples, drug substance and drug product, and environmental monitoring. + Conduct routine area walkthroughs to ensure laboratories operate in a state of control and comply with current Good Manufacturing Practices (cGxP). **Test Method and Material Lifecycle Management:** + Oversee the qualification, validation, and transfer of analytical methods, critical reagents, and reference standards. + Review and approve associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards. **Technical Leadership and Support:** + Serve as a Subject Matter Expert (SME), providing advanced technical guidance and troubleshooting support for complex laboratory and quality-related issues. + Make informed decisions with minimal guidance, proactively seeking input when addressing cross-functional challenges. + Assist in workload management by prioritizing and distributing tasks across the team to ensure efficient execution of responsibilities. **Data and Documentation Review:** + Review and authorize laboratory testing data within Laboratory Information Management Systems (LIMS). + Review and approve Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support batch disposition. + Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements. **Quality Systems and Compliance:** + Lead or support nonconformances and deviations related to QC processes, including laboratory investigations, Out of Specification (OOS), and Out of Trend (OOT) results. + Author, review, and approve controlled documents such as Standard Operating Procedures (SOPs), specifications, protocols, and reports for Quality and GMP-related functions. + Author, review, and approve Quality System records, including Nonconformances, Corrective and Preventive Actions (CAPAs), and Change Management documentation, with thorough causal and impact assessments. **Qualifications** **Required:** + Bachelor's degree in a related scientific or technical discipline with 5-8+ years of experience in biotechnology or pharmaceutical industry or a Master's degree and 3-5+ years of experience in biotechnology or pharmaceutical industry. + Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality Control environment. + Strong knowledge of Quality Control laboratory operations and systems. + Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices. + Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects + Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others + Excellent problem-solving skills and experience with root cause investigations and CAPA determination + Off hours coverage and flexibility may be required **Preferred:** + Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product) + Knowledge and experience within a Quality Control discipline and/or method validation. + Experience working in a Laboratory Information Management system **Working Environment:** + This position is based at Astellas in Sanford, NC and will require on-site work in a cGMP regulated manufacturing facility (80-100%). + On occasion, this role may travel to other Astellas facilities (0-5%). + Flexible grade level based on candidate background and skillset. **Salary Range** **:** $93,100 - $146,300 (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 \#LI-TD Category BioPharma QA Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

The Scientist 1, QC Microbiology supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do Performs non-routine complex testing, identifies requirements and executes actions as part of change control process. Assists and guides others in the lab with routine testing Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision Leads qualification and study directed testing activities Reviews and evaluates advanced lab testing results Acts as a qualified trainer and Subject Matter Expert (SME) of multiple tests Authors, reviews, and edits documents and study protocols • Supports intermediate investigations of OOS assays and events Ensures compliance with cGMP and participates in audits and inspections Supports laboratory management and mentors' others on the team, as needed Leads LEAN lab and six sigma principles and applies them to laboratory processes Acts as project leader for projects in the lab and department Leads audit readiness and participates/supports for the team Performs other duties, as assigned Minimum Requirements: Bachelor's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years' experience OR Master's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years' experience OR PhD with 1+ years of applicable industry experience 3+ years of experience working in a regulated GMP environment Expert understanding of GMP, GLP, GDP requirements Experience and proficient knowledge in Microbiology theory Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing Advanced LIMS experience Advanced experience with document control including writing and editing technical documents and presentations Preferred Requirements: SME level knowledge in Microbiology theory SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing Investigations training (Trackwise or similar) LEAN/6S certification Familiarity with global regulatory guidelines and testing implications Physical and Work Environment Requirements: Will work in environment which may necessitate respiratory protection X No Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes Ability to discern audible cues. No X Yes Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes Ability to ascend or descend ladders, scaffolding, ramps, etc. x No Yes Ability to stand for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to sit for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes Ability to operate machinery and/or power tools. X No Yes Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.) Will work in outdoor elements such as precipitation and wind. X No Yes Will work in small and/or enclosed spaces. No X Yes Will work in heights greater than 4 feet. No X Yes --- To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: * Advance innovative science by pushing boundaries. * Bring transformative therapeutics to patients in need. * Provide an environment for employees to reach their fullest potential. Our values: * Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. * Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. * Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. * Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. * Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Quality Control Specialist is an entry level opportunity within the Quality Control organization at AskBio. This individual will perform routine GMP testing activities in a regulated gene therapy manufacturing environment. This position is responsible for analytical testing using established methods, preparing reagents and solutions, and supporting the maintenance of cell lines used across multiple clinical programs. The QC Specialist plays a critical role in ensuring data integrity, compliance and operational excellence within the QC laboratories. The Quality Control Specialist, reporting to the Manager of Quality Control, will be an office-based position in RTP, NC. Job Responsibilities * Perform routine analytical testing including but not limited to cell-based potency assays, dd PCR, qPCR, ELISAs, limit tests using HPLC techniques * Prepare solutions and maintain cell lines for various clinical programs * Prepare laboratory solutions, maintains cell lines, and other day to day laboratory activities * Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data * Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records * Assist with management of analytical test method supplies and samples as needed * Ensure lab areas are clean and organized, maintaining equipment and consumables * Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments * Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external * Participate in continuous improvement projects in the AD and QC labs * Support revisions to work instructions, SOPs, forms, protocols, and reports Minimum Requirements * Bachelor's degree in biology or related field * Excellent verbal and written communication skills * Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team * Ability to handle multiple projects/teams simultaneously * Ability to work independently in a fast-paced, highly interactive environment with minimal supervision Preferred Education, Experience and Skills * Relevant work experience in cGMP regulated Quality Control laboratory * Experience working for a pharmaceutical or biotech company * GDP experience * Experience with cell-based assays and PCR testing * Experience working within a cGMP Quality Control LIMS system AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

Responsibilities: Assay execution GMP documentation Maintenance and cleaning of the lab equipment Requirements / Qualifications: Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience 6 years would be ideal, GMP experience is a must, extensive experience with cell based methods, Elisa, Aseptic techniques and hands on experience with various assays is required Experience with Quality Control. Ability to work independently and quickly take ownership of tasks Strong data analysis skills. Nice to have: immunology, biology, and chemistry background.

Job Description - The Quality Control Raw Materials Chemist III ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and potentially external clients Essential Functions Perform testing of raw materials, packaging components, and other samples. Author or act as author for lab investigations, analytical testing methods, deviations, protocols and SOPs for raw materials and raw material instrumentation. Provide technical support to the laboratory for method and instrument troubleshooting as needed. Lead the Raw Materials laboratory implementation project by overseeing installation, qualification, and training on new instruments and techniques. Provide training for other analysts for raw materials testing Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules and timelines. Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks. Oversight for review of QC Raw Material data for compliance with specifications and regulatory requirements Interact with third party laboratories for any microbial and analytical testing of raw materials Generate and/or review shipping paperwork for third party testing and prepare samples for shipment. Create purchase requisitions for lab supplies and third-party testing Perform weekly laboratory audit inspections Perform sampling of raw materials as needed Review third party laboratory investigations and protocols. Other duties as assigned Powered by JazzHR IhEoyEcRDL

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Location : Mebane, NC 27302 Duration : 6 months contract (With a high possibility of extension) • ISO 9000 experience • Manufacturing experience (work in manufacturing plant environment) • Leadership skills (facilitate meetings, drive change, lead team, etc) • Strong MS excel skills • SAP experience will be a plus (not required by highly desired) Job description: • Take responsibility for continuous improvement of production operations including safety, scheduling, quality, Lean and training/development in assigned areas • Develop and maintain Quality Management System documents such as manufacturing methods, technical documentation, and training documentation • Support and facilitate investigations, root cause analysis and corrective actions. • Practice analytical problem solving incorporating use of strong math skills • Demonstrate initiative to learn and seek improvement opportunities with minimal direction Qualifications • Must have a Technical or Business Associates degree or equivalent work experience. • Minimum 3 year quality control experience • Minimum 1 year ISO and/or regulatory experience • Demonstrate understanding of quality procedures and concepts • Demonstrated lean manufacturing participation • Demonstrated EHS participation and support Additional Information To know more about this position, please contact: Himanshu Prajapat ********************************** ************

Job Description : A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** POSITION OVERVIEW: We are seeking a Quality Associate, Commissioning & Validation (Mid to Junior level) to support the commissioning and validation of a manufacturing facility. This role is responsible for reviewing, verifying, and documenting that equipment and systems are commissioned, qualified, and validated in alignment with GMP expectations. You will work closely with engineering and technical teams to ensure activities remain compliant, complete, and on schedule. This is a hands-on quality role requiring strong attention to detail and the confidence to identify gaps and advocate for corrective actions when needed. WORK LOCATION: On-site presence at manufacturing or project locations is required during active commissioning activities. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Commissioning and Qualification Review commissioning, IQ, OQ, and PQ protocols and reports for GMP equipment and systems Verify execution aligns with approved protocols and regulatory expectations Ensure deviations, discrepancies, and punch list items are documented and resolved Confirm traceability from requirements through execution and final approval Quality Oversight Provide quality review and approval of validation deliverables Ensure documentation meets data integrity and GMP standards Support risk assessments, impact assessments, and change controls tied to commissioning activities Escalate compliance risks clearly and early Cross-Functional Collaboration Work directly with engineering, automation, facilities, and manufacturing teams Support technical teams by clarifying quality expectations and documentation needs Help teams close gaps without unnecessary delays Schedule and Readiness Support Track review timelines and follow up to maintain progress Support inspection readiness related to commissioning and validation activities Assist with responses to internal or external audit questions QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Education : Bachelor's degree in science, engineering, or a related field Technical Experience : 2 to 5 years of experience in GMP manufacturing, quality, validation, or commissioning support Working knowledge of equipment qualification and validation lifecycle Familiarity with GMP documentation standards and regulatory expectations Preferred Experience : Experience supporting facility start-ups, expansions, or tech transfers Exposure to commissioning and qualification of manufacturing equipment or utilities Understanding of FDA, EMA, and ICH GMP expectations Experience working in fast-paced, cross-functional project teams Skills and Attributes : Detail-oriented with strong documentation discipline Comfortable working with technical and engineering teams Able to manage multiple reviews simultaneously Clear communicator capable of raising issues constructively Practical mindset focused on compliance and execution ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Edwards, Inc. is a full-service industrial general contractor providing construction, fabrication, and crane services. We are currently seeking a Day Shift Quality Control Welding Inspector for our Spring Hope, NC, Pipe Fabrication Shop. This position is Monday through Thursday 6am to 6pm. Fridays and Saturdays are possible depending on workload. The QCI Inspector will be responsible for: Reading and interpreting shop fabrication and isometric drawings. Verifying pipe spools dimensions as fit-up to shop fabrication and isometric drawings. Verifying heat number traceability is correct as recorded. Provide a visual weld examination of shop welding. Verify welding filler materials are in compliance and the LOT traceability is recorded. Monitor welding to ensure weld procedure specifications are being followed, correctly. Verify weld preparations, weld sizes, and weld placement in accordance with shop weld details. Ideal Candidates Should Have: Physical requirements include, but are not limited to: Continually walk/stand on surfaces which may be even/uneven, stable/unstable, and varying compositions. Work in awkward spaces and/or positions including confined spaces and climbing. The ability to routinely lift up to 135+ lbs. Excellent hand/eye coordination, depth perception, and peripheral vision. Essential Requirements & Skills: Requirements 5 years of experience in industrial piping (preferred but not required) Organizational Skills Able to interpret basic weld symbols as defined by AWS A2.4 Able to read and interpret Codes (i.e. ASME B31.1, B31.3, etc.) Ability to read shop fabrication and isometric drawings. Ability to read dimensional measuring devices. Experience in reading weld procedures and specifications (Preferred) Current AWS Certified Welding Inspector (preferred but not required) Excellent communication skills and commitment to safety. Additional Skills Valid Driver's License (Preferred) High School Diploma or Equivalent Bilingual Skills (English/Spanish) is a plus but not required. Competitive Benefits Package: Health / Dental Insurance Disability Life Insurance Paid Time Off: Vacation and Holiday 401(k) with company match And more! Working conditions may be indoor or outdoor. Schedule may include overtime, overnight, and weekend work. Pre-employment investigations and evaluations may include drug, physical functionality, criminal background, MVR and/or skills evaluations. Pay commensurate with experience/knowledge. Edwards, Inc. is an Equal Opportunity Employer and participates in E-Verify. Application may be made in person, or an application may be completed online at ************************************ Pre-employment investigations and evaluations may include drug, physical functionality, criminal background, MVR and/or skills evaluations. Edwards, Inc. is an Equal Opportunity Employer and participates in E-Verify.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description • Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and quality standards. • Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples. • Displays strong investigative or technological orientation with independence for design of projects/studies. • Organizes and provides written and/or oral presentations of work with minimal input. • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance. • Responsible for final authorization/approval/release of documentation/equipment/processes. • Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility • Plans and leads projects to ensure their timely completion. • Provide guidance/coaching to junior colleagues. Qualifications • Minimum 5 - 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry. • BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry • University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred. Additional Information Thanks Warm Regards Ricky Bansal 732-429-1925