Quality control analyst jobs in North Carolina - 358 jobs

Founded in 1992, InServ is a full-service industrial contractor working in the life science, advanced manufacturing, and food and beverage industries. We specialize in four trades (mechanical, hygienic piping, HVAC, and electrical, instrumentation and controls), working from multiple locations across North Carolina and for clients across the Southeast. InServ is both a knowledgeable and reliable partner for our clients. We assist with design, adhere to schedules, and execute with the highest quality to provide a total solution. ESSENTIAL DUTIES AND RESPONSIBILITIES: Conduct daily walk-through surveillances on assigned project(s) and/or fabrication facilities. Evaluate to ensure conformance and compliance with contractual specifications, government regulations, and InServ's QA/QC policies and procedures. Inspect materials and fabricated products, on-site materials/equipment, and verify installation processes to ensure compliance with contract specifications and regulatory standards. Document and communicate inspection results. Identify and recommend solutions for non-conforming items and nonconformance of QA/QC policies and procedures. Follow-through to ensure nonconformances are resolved. Disseminate written policies and procedures related to compliance activities. Interpret specifications and clarify procedural issues for workers. Verify that all contractual and regulatory policies and procedures have been documented, implemented, and communicated for the project, and as directed by QA/QC Manager or Supervisor. Assess product for compliance to specifications and procedures. Assist with the development of risk management strategies. Contribute to suggestions for improvements in communication and monitoring. Maintain daily logs of project quality and surveillances. Support logged information with photographs/videos - photographing must be in accordance with client's privacy policies. File appropriate and timely inspection and compliance reports. Updated: 1/31/25 JD-QA/QC Inspector: Page 2 of 2 Discuss violations of QA/QC policies and/or specifications for potential stop-work orders with the QA/QC Manager and project management. Explain specifications, regulations, and/or QA/QC procedures and recommend rectifications. Train subcontractors on quality requirements and compliance, as necessary. Perform additional assignments per supervisor's direction. Travel Requirements: Skills, Knowledge, Qualifications & Experience: High school diploma or equivalent; some advanced education and/or technical training is desired. Self-motivated with a desire to be among a strong supportive team. AWS Certified Welding Inspector is desired. Prior NDT Level II (VT) certification is required, in accordance with SNT-TC-1A and endorsed by an ASNT NDT Level III. 3 years minimum experience in Visual Testing (VT). Welding experience is preferred but not required. Biopharmaceutical, high-purity inspection experience is required. Thorough knowledge of all aspects of construction (technology, equipment, processes, and methods). Thorough knowledge of company QA/QC policies, procedures and standards. Strong oral and written communication skills. Ability to identify, troubleshoot and resolve problems before major difficulties develop. Auditing skills. MS Office skills and ability/desire to learn new software. Excellent communication, organizational, and planning skills. Employment is contingent upon satisfying all jobsite-specific access requirements, with no outstanding restrictions from any jobsite or from working with any of InServ's partnering General Contractors, Owners, Customers, etc.

Job Title: Chemist Duration: 06 Months Pay Rate: $25/hr on W2 Shift: 7:00AM-5:30PM (Mon -Thurs) but there is some flexibility in start time Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and company policies and procedures. Perform routine testing (dissolution, assay/degradant, content uniformity and ID) of drug products in a cGMP laboratory. Complete all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures. Enter data into laboratory information system and accurately document all necessary and relevant information in a clear concise manner as per cGMPs. Operate and maintain all analytical instrumentation and equipment as per established procedures; perform basic troubleshooting. Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency. Aid other group members as required. Ensure that equipment and working areas are maintained with good safety and housekeeping practices. Re-stock chemicals and consumables used in analysis. Performs other related assignments and duties as required and assigned. Skills: Understanding of analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy - UV/Vis, NIR, IR, or AA/AE). Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position. Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting. Lift and maneuver equipment and materials weighing up to 20 pounds. Take samples which may require stretching, bending, or twisting to remove product from the equipment and/or drums. Use small hand and power tools to perform incidental maintenance. Perform cleaning and assembly/disassembly on laboratory equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts could weigh up to 20 pounds. Also requires operation of industrial hose (water) and physical exertion (repetitive wiping, rubbing and scrubbing) to clean equipment and laboratory surfaces. Ability to work a 10 hour per day/4-day work week Monday through Thursday; 40 hours per week with overtime as required. Education: The incumbent must have a BA or BS degree in Chemistry or closely related science. Minimum of 1-year relevant experience preferred.

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

The Sr. Analyst 1, QC Virology works with limited direction to execute QC analytical methods requiring aseptic technique, including viral infectivity assays, mammalian cell culture, growth and purification of viral stocks, titering of viral stocks, and PCR-based methods. The Sr. Analyst 1, QC Virology adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Sr. Analyst 1, QC Virology is primarily responsible for executing routine Virology methods in support of manufacturing, supporting laboratory execution of method qualifications, maintaining cell banks and stocks, growing viral stocks, and training other QC Virology laboratory associates. 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 * Executes analytical methods that require aseptic techniques, including viral infectivity assays, qPCR assays, 28-day and 14-day Adventitious Agent assays, growth and purification of viral stocks, titering of viral stocks, and cell culture maintenance• Ensures analytical testing of in-process samples is performed according to appropriate GMP regulations• Ensures analytical testing data is captured in LIMS software• Reports assay performance and assists with the implementation of improvements that ensure quality and efficiency within QC Virology• Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs)• Coordinates and supports QC Virology lab activities as needed• Provides training for QC Virology associates• Authors and reviews SOPs and technical reports• Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives• Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific disciplinewith 2+ years of relevant experience• 3+ years laboratory experience • 1-3 years GMP laboratory experience• Experience working with BSL1 and BSL2 viruses in a GMP lab environment including mammalian cell culture propagation and maintenance. Preferred Requirements: * Master's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience• Experience working in a Virology lab in an GMP Environment• Experience with LIMS software preferred Physical and Work Environment Requirements: Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 60 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. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. Will work in small and/or enclosed spaces. Will work in heights greater than 4 feet. 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_****************).

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_****************).

This role contains the following responsibilities covering 2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday: The Senior QC Analyst (2nd Shift) will be trained to execute analytical test methods and their corresponding analytical techniques. The core function is composed of completing QC testing for in-process, characterization, release, or stability samples. Additionally, when need arises, Senior QC Analyst will assist with troubleshooting and support In-process Support Associates with STAT samples during 2nd shift. Responsibilities include: In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or direction Execution of method transfer, method qualification, and/or method validation testing performed under protocol Solution preparation Organizes and processes samples according to GxP standards Independent analysis and collation of data to draw conclusions Enter data into control charts and LIMS, if applicable Supports lab investigation and deviation reports Supports implementation of Corrective and Preventive Actions Revises SOPs and technical documents Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data Tracks department metrics upon request; actively engages in improvement of department metrics Partakes in continuous improvement projects or leading simple improvement projects Ensures state of safety and regulatory audit readiness at all times Maintains work to current Good Manufacturing Practices (cGMP) Ensures Trainer qualification status to expand team matrix Laboratory support - ensures areas are neat, clean, organized, and equipment is functioning Participates in data review activities Duties may include support in STAT testing coordination It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility Minimum Requirements: Relevant degree and 4-8 years' biopharmaceutical industry experience, preferably in protein analytics Salary: $63,000-$86,900 KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. 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.

Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: Greenville, NC/DPD How Will You Make an Impact?: As a Formulation Technician II, you will play a vital role in producing sterile injectables and working on moderate-scale problems that require analysis and critical thinking. You will follow written and verbal instructions to ensure that pharmaceutical products are manufactured in accordance with industry guidelines and regulations. Night and day full time shifts available. Shift hours are 6pm-6am or 6am-6pm on a 2-2-3 rotating schedule. A Day in the Life: Ensure pharmaceutical products are manufactured in strict accordance with area SOPs and current cGMP. Verify and document production activities in batch records, logbooks, and controlled forms. Complete tasks vital to manufacturing drug products in an aseptic filling area, including cleaning cGMP areas, performing line changeovers, parts preparation, filter integrity testing, operating parts washers and autoclaves, performing tray loading and unloading, operating the filling isolator, and general material handling. Troubleshoot equipment alarms. Education: High school diploma or equivalent required. Experience: Required: Minimum of 1 year of work experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment Knowledge, Skills, Abilities: Ability to excel in a team environment, follow standard operating procedures, and perform repetitive work duties Basic math skills. Good verbal/written communication. Attention to detail while maintaining a quality product. Physical Requirements / Work Environment Work in a clean-room environment with controlled temperature, humidity, and low ambient noise. Wear appropriate gowning and personal protective equipment. Infrequently lift and manipulate up to 50 pounds unassisted. Stand and move about, including reaching, bending, stooping, grasping. Use hand tools and equipment. What We Offer: Compensation Competitive Pay Performance Related Bonus where eligible Annual merit performance-based increase Excellent Benefits Medical benefits Paid Time Off/Annual Leave Employee Referral Bonus Career Advancement Opportunities

Come join our family! Microbac Laboratories is an essential business offering competitive pay and benefits including medical, dental, vision, life insurance, disability, generous paid time off including vacation, holidays and flex-time, a wellness program, referral bonus, tuition reimbursement and more! Whether you are just starting your career in science or looking to further it, Microbac will put you on the path of an exciting career with room to grow. Quality, safety, giving back to our communities, diversity and inclusion, customer success and employee wellbeing are part of our core culture. We are looking for motivated individuals to join our family as a Microbiology Analyst II. ABOUT MICROBAC Microbac serves our clients with the utmost expertise and respect for their market requirements, constraints and challenges. We embody a company-wide commitment to exceptional customer experience, which has been refined over nearly 50 years of trusted, analytical and measurement experience. Through our network of laboratories, offices, and field services, we have the flexibility to meet the unique requirements for each client, project and scope. As a privately held third-party testing company, Microbac operates with a commitment to safety, quality and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets. JOB SUMMARY We are currently seeking a full-time Microbiology Analyst II, working in an accredited commercial laboratory, responsible for performing microbiological testing, data analysis, and documentation to ensure product quality and regulatory compliance. This role involves operating specialized lab equipment, supporting method development, and supervising junior staff. The analyst also collaborates with Quality Assurance, contributes to investigations and audits, and helps maintain a high standard of laboratory accuracy, safety, and efficiency. ESSENTIAL FUNCTIONS: Operate, calibrate, and maintain specialized laboratory instrumentation for microbiological testing, such as incubators, autoclaves, microscopes, and particle counters. Prepare media, reagents, and samples for analysis following SOPs (Standard Operating Procedures). Ensure proper aseptic techniques to prevent contamination. Identify microorganisms using traditional and/or rapid methods (e.g., Gram staining, biochemical tests, MALDI-ToF). Maintain microbial culture collections and growth promotion. Monitor sample workflows and proactively address backlogs to ensure timely completion of testing. Manage laboratory supplies and support procurement activities for relevant departments. Perform advanced microbiological testing on raw materials, finished products, and environmental samples. Accurately record detailed observations, analyze data, interpret test results, and maintain documentation in lab notebooks and LIMS. Assist in the development, validation, and implementation of new test methods and procedures. Investigate anomalies or inconsistencies in analytical data and implement corrective actions. Explore and evaluate new technologies or methodologies to enhance laboratory capabilities. Prepare and review Certificates of Analysis (CoAs) and other technical documentation. Ensure all documentation complies with internal SOPs and external regulatory standards. Adhere to and enforce Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and other relevant quality standards as well as relevant guidelines, such as FDA, USP. Participate in quality investigations (e.g., OOS, deviations) and support root cause analysis and CCP development. Collaborate with the Quality Assurance team to review, revise, and maintain SOPs. Support internal and external audits by ensuring laboratory readiness and documentation accuracy. Provide day-to-day supervision, mentorship, and training to laboratory technicians and junior analysts on equipment usage, testing protocols, and laboratory practices. Assign and oversee daily testing activities to ensure efficient and compliant lab operations. Review and approve analytical results and reports, including peer review of data generated by junior staff to ensure accuracy and compliance. Support ongoing staff training and contribute to performance evaluations and development planning. Other duties as assigned MINIMUM REQUIREMENTS: Bachelor's degree from a four-year accredited institution in a related field of applied science; plus, five or more years of related experience; or six plus years of related laboratory experience with no degree Strong understanding of principles, terminology, practices, techniques and instrumentation commonly used in a laboratory setting Ability to interpret data, record observations, prepare reports, and perform peer review Ability to effectively prioritize work and manage time to meet deadlines and rush orders Computer literacy Ability to work with delicate laboratory equipment Ability to communicate effectively in both written and verbal formats Ability to understand and adhere to established SOPs PREFERRED QUALIFICATIONS: A general understanding of terms and concepts typically used throughout the industry is preferred WORKING CONDITIONS AND PHYSICAL REQUIREMENTS: The physical demands and working conditions 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 the essential functions. Physical Requirements: While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools; talk or hear. The employee is occasionally required to stand, walk, and sit. The employee must regularly lift and/or move up to 25 pounds. Specific vision abilities required by this job include color vision and depth perception. Working Conditions: While performing the duties of this job, the employee will be in a general office environment. The noise level in the work environment is usually moderate. This job may require travel less than 20% As a privately held third-party testing company, Microbac operates with a commitment to safety, quality and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets. OTHER: This is not an exhaustive list of all duties an employee may be required to perform. Microbac reserves the right to revise the job description at any time. Employment is at-will. Microbac, promotes a drug-free, alcohol-free workplace. Applicants considered for hire must pass a drug test before beginning work. Refusal to submit to testing will result in disqualification of further employment consideration. Microbac is an Equal Opportunity Employer - We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. All qualified applicants will receive consideration for employment.

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Its a simple route driver job and company will be providing the car. Job Description: The CQ Lab Analyst I, will perform basic analysis for raw materials, in process and/or finished products in a safe, compliant, and efficient manner. The Job responsibilities include performing wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality. Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required. • Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified. • Follows procedures at all times, adopting cGMP, cGDP practices. • Follows supervisor directions at all times. • Able to function independently, but asks questions as necessary • Accepts dynamic work sequences • Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed • Consistently communicates work sequence status to supervisor in a timely manner. • Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement. • Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals. • When faced with roadblocks and issues, routinely offers suggestions for improvements • Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift wherever possible. • Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter Education experience required: BS/MS in Chemistry or BS Science Degree, 0-2 years of experience Qualifications Education experience required: BS/MS in Chemistry or BS Science Degree, 0-2 years of experience Additional Information All your information will be kept confidential according to EEO guidelines.

LanceSoft is a nationally certified Minority Business Enterprise (MBE) that has established itself as a pioneer in providing highly scalable, cost-effective workforce solutions to a diverse set of customers across various industries in the United States. Headquartered in Virginia, LanceSoft currently operates out of several locations in the US and Canada. Title: QC Chemist Location: Rocky Mount, NC Duration: 18 Months Job Description: The CQ Lab Analyst I, will perform basic analysis for raw materials, in process and/or finished products in a safe, compliant, and efficient manner. The Job responsibilities include performing wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality. Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required. • Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified. • Follows procedures at all times, adopting cGMP, cGDP practices. • Follows supervisor directions at all times. • Able to function independently, but asks questions as necessary • Accepts dynamic work sequences • Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed • Consistently communicates work sequence status to supervisor in a timely manner. • Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement. • Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals. • When faced with roadblocks and issues, routinely offers suggestions for improvements • Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift wherever possible. • Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter Additional Information Regards, Anuj Mehta ************

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website ************************ We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well. Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset. Job Description The CQ Lab Analyst I, will perform basic analysis for raw materials, incoming materials, in process and/or finished products in a safe, compliant, and efficient manner. The Job responsibilities include performing visual, dimensional, and physical testing in support of commodity, wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality. Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required. • Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified. • Follows procedures at all times, adopting cGMP, cGDP practices. • Follows supervisor directions at all times. • Able to function independently, but asks questions as necessary • Accepts dynamic work sequences • Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed • Consistently communicates work sequence status to supervisor in a timely manner. • Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement. • Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals. • When faced with roadblocks and issues, routinely offers suggestions for improvements • Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift wherever possible. • Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter • For Incoming Material CQ lab analyst, has understanding of Assurance Quality Limit (AQL) and sampling procedures and tables for inspection by attributes (ANSI/ASQ Z1.4). Qualifications Bachelors or Masters Additional Information Sneha Shrivastava Sr Technical Recruiter 862 - 579 - 4236

No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries. POSITION SUMMARY : The Microbiology Analyst is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests on in-process and final container products, as well as environmental monitoring samples. This position also contributes to the completion of regular routine technical tasks. JOB RESPONSIBILITIES : Help maintain inventory by reporting needed supplies. Take appropriate steps to reduce wastages and losses in the Microbiology department. * Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples. * Successfully complete a gown qualification program to enter and work inside the aseptic manufacturing area. * Perform critical manufacturing process interventions for viable and non-viable EM. * Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples. * Perform routine sampling of critical process utilities (e.g., Water-for-Injection, Purified Water, Clean Compressed Air, Nitrogen Distribution System, etc.) * Count colony forming units (CFU) on Petri plates. * Perform sterility testing on final products and raw materials. * Perform Growth Promotion and Biological Indicator testing. * Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods. * Maintain accurate and complete test records. * Enter test results in the Laboratory Information Management Systems (LIMS). * Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples. * Maintain current knowledge of regulatory and industry standards, trends and advancements. * Other duties as identified by direct supervisor * Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications and/or limits (OOS/OOL). * Performs routine equipment maintenance. * Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary. * Establishes good working relation with contract laboratories. * Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols. * Supports activities regarding audits of suppliers and contract labs in support of vendor certification program. * Conducts statistical evaluation of the manufacturing and inspection process and training QC staff. * Assures laboratory databases are maintained and accurate. * Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing. * Ensure that all equipment is calibrated. Education : * Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent. * Microbiology degree preferred Experience : * 1-3 years of experience in a cGMP/GLP laboratory. * Pharmaceutical & FDA/GMP industry experience is preferred. * Microbiology laboratory experience, such as aseptic techniques required Knowledge and Skills : * Knowledge of current cGMP regulations for laboratory setting * Proficient in Windows, Microsoft Word, Excel. * Good written, verbal, and communication skills. * Good documentation skills. * Strong organizational skills.

JLA International, a Leader in Food Safety, is now accepting applications for a Microbiology Analyst - 2nd shift position at its facility in Edenton, NC. Ideal candidates will possess the following: - An associate degree (required); a BS or BA in the Microbiology or related field (preferred) - Strong attention to detail - Proficiency with data entry and computer applications - Ability to multitask and work in a fast paced environment - Strong written and verbal communication skills - Strong understanding of aseptic technique in the laboratory Microbiology Analyst duties include: analysis of food samples for pathogens via PCR and immunoassay, various microbe enumerations, compositing and plating samples using aseptic technique, data entry, laboratory reporting, quality control, media preparation, dish washing, and other duties as assigned. This is a full-time position in which the employee will be eligible for standard benefits after a brief waiting period. The schedule for this position is Monday through Friday, from 12:00pm - 8:30pm. The laboratory operates weekends, so candidates must be willing to work some weekends. Due to exposure to various food allergens in the laboratory environment, applicants with moderate-to-severe food allergies are discouraged from

The Senior Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein A), dot blot for product identity, ELISA ID/ Potency and various cell-based assays. The Senior Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and author and review procedures, SOPs, and technical reports. 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 Executes analytical method transfers and validations for plate and cell-based Bioassays for the QC Analytical Development team. Ensures compliance of analytical testing with appropriate GMP regulations. Participates in regular meetings for TT programs with cross-functional teams and key stakeholders. Authors and reviews SOPs, protocols, and technical reports. Works cross-functionally with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure transfer of methods according to deadlines. Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests and inspections. Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques, as needed. Supports best practices for TT and PPQ strategies globally, as required. Coordinates and supports QCAD Bioassay lab activities and provide training for QC Bioassay lab technicians. Performs other duties, as assigned. Minimum Qualifications Bachelor's Degree in Microbiology, Virology, Biology, Biological Sciences, Engineering, or related science field with 2+ years of analytical laboratory experience preferably in Biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO); OR, Master's Degree in Virology, Microbiology, Biology, or related science field with Microbiology, Virology, Biology, Biological Sciences, Engineering, or related science field with 0+ years of previous experience. 1+ years of experience in a GMP environment. Experience with QC Bioassay testing methods including protein binding assays (e.g. ELISA, Dot Blot, etc.). Experience with analytical method development, tech transfers and validation residual testing for DNA, Host Cell Protein (HCP), Protein A. Preferred Qualifications Master's in Virology, Microbiology, Biology or related science field with 1+ years of related experience. Experience with LIMS software. 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: Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 60 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. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. Will work in small and/or enclosed spaces. Will work in heights greater than 4 feet. 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_****************).

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Its a simple route driver job and company will be providing the car. Job Description: The CQ Lab Analyst I, will perform basic analysis for raw materials, in process and/or finished products in a safe, compliant, and efficient manner. The Job responsibilities include performing wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality. Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required. • Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified. • Follows procedures at all times, adopting cGMP, cGDP practices. • Follows supervisor directions at all times. • Able to function independently, but asks questions as necessary • Accepts dynamic work sequences • Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed • Consistently communicates work sequence status to supervisor in a timely manner. • Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement. • Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals. • When faced with roadblocks and issues, routinely offers suggestions for improvements • Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift wherever possible. • Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter Education experience required: BS/MS in Chemistry or BS Science Degree, 0-2 years of experience Qualifications Education experience required: BS/MS in Chemistry or BS Science Degree, 0-2 years of experience Additional Information All your information will be kept confidential according to EEO guidelines.

LanceSoft is a nationally certified Minority Business Enterprise (MBE) that has established itself as a pioneer in providing highly scalable, cost-effective workforce solutions to a diverse set of customers across various industries in the United States. Headquartered in Virginia, LanceSoft currently operates out of several locations in the US and Canada. Title: QC Chemist Location: Rocky Mount, NC Duration: 18 Months Job Description: The CQ Lab Analyst I, will perform basic analysis for raw materials, in process and/or finished products in a safe, compliant, and efficient manner. The Job responsibilities include performing wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality. Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required. • Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified. • Follows procedures at all times, adopting cGMP, cGDP practices. • Follows supervisor directions at all times. • Able to function independently, but asks questions as necessary • Accepts dynamic work sequences • Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed • Consistently communicates work sequence status to supervisor in a timely manner. • Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement. • Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals. • When faced with roadblocks and issues, routinely offers suggestions for improvements • Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift wherever possible. • Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter Additional Information Regards, Anuj Mehta ************

No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. The Senior Microbiologist is a critical technical resource in the QC Microbiology laboratory supporting the manufacturing of sterile injectable products. This position is responsible for independently performing and overseeing complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA, and internal quality standards. This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological testing. Maintains spreadsheets and databases to track and monitor department/company data, KPIs and metrics. Accountable for QC Microbiology inventory control including ordering materials, maintaining stock and resolving material complaints as needed. This role will serve as a Subject Matter Expert (SME) to provide guidance and support junior microbiologists. Train team members in aseptic technique, microbiological methods, EM sampling, and good documentation practices. Participate in the qualification of microbiology lab equipment. Identify and implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory. OVERALL JOB RESPONSIBILITIES: Operational Excellence: * Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct. * Communicate progress, status, and roadblocks as required. * Drive projects, assignments, and complete presentations within timelines and budgets. Create and maintain relevant metrics for department/site. * Spreadsheets and databases will be leveraged for departmental and company metrics, presentations, and data/testing tracking/verification. The Senior Microbiologist is responsible for keeping these sheets and databases up to date. * Ability to perform routine testing of samples submitted to the laboratory as appropriate. Schedules and participates in cleaning, inventory, and maintenance tasks in the lab. * Supports inventory management and ordering/stocking of all QC department laboratory supplies. * Ensures laboratory equipment is in compliance with procedures and GLP requirements. * Troubleshoots laboratory issues related to all instrumentation. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory. * Performs GMP review of test data to ensure that test results meet all specifications. Trends data and analyzes trends to proactively mitigate equipment and reagent performance issues. Verifies laboratory equipment and associated equipment logs to ensure proper operation Stakeholder: * Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS). * Performs routine equipment maintenance. * Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary. * Establishes good working relation with contract laboratories. * Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ/PQ protocols. * Supports activities regarding audits of suppliers and contract labs in support of vendor certification program. * Conducts statistical evaluation of the manufacturing and inspection process and training QC staff. * Ensure that all equipment is calibrated. * Responsible to develop and validate new test procedures * Perform data analysis, compile data and generate reports for management review. * Review lab test data and their integrity and adherence to SOPs and cGMP. Compliance: * Maintain current knowledge of regulatory and industry standards, trends and advancements. * Responsible for ensuring compliance to systems and procedures in the EM/Microbiology laboratory and cleanroom areas. And prepare the lab for internal and external audits. * Support Continuous Improvement initiatives by providing support on updating SOPs, WIs, and OJT * Complete and maintain certified investigator training requirements. Perform investigation of the quality events assigned using root cause analysis tools, maintain timelines for closure of investigations and identify/initiate CAPAs * Complete and maintain status as a certified trainer * Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures * Evaluates and assists in the implementation of new changes at the site, including providing training on an as needed basis * Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation. * Performs regular self-audits of the Microbiology and EM laboratory areas (including storage areas) and assists/leads activities to address audit findings. Stakeholder: * Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations. Innovation: * Supports purchasing QC EM laboratory supplies. Makes sound, well considered decisions to make the most of available funds and resources. Monitors lab supply costs and looks for ways to work with suppliers to reduce consumables cost when appropriate. * Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. Makes realistic and actionable plans to address supply chain issues. * Maintains the QC department ordering system to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies. Safety: * Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties KNOWLEDGE, SKILLS AND ABILITIES: Education: * Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology Experience: * Minimum of 3+ years in a pharmaceutical environment * Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently. * Excellent written communication and technical writing skills. Clearly demonstrates competence in the selection and use of root cause analysis tools and techniques (e.g., 5 Whys, Pareto Analysis, 5M +E). * Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks. * Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs). * Displays ability to achieve Glenmark Monroe QE investigator certifications for product/process/testing/facility issues with product and non-product impact. * Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues. * Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system. * The ability to work independently and within team structure and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills. Ability to lift 30 lbs. and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions.

No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. The Senior Microbiologist is a critical technical resource in the QC Microbiology laboratory supporting the manufacturing of sterile injectable products. This position is responsible for independently performing and overseeing complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA, and internal quality standards. This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological testing. Maintains spreadsheets and databases to track and monitor department/company data, KPIs and metrics. Accountable for QC Microbiology inventory control including ordering materials, maintaining stock and resolving material complaints as needed. This role will serve as a Subject Matter Expert (SME) to provide guidance and support junior microbiologists. Train team members in aseptic technique, microbiological methods, EM sampling, and good documentation practices. Participate in the qualification of microbiology lab equipment. Identify and implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory. OVERALL JOB RESPONSIBILITIES: Operational Excellence: Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct. Communicate progress, status, and roadblocks as required. Drive projects, assignments, and complete presentations within timelines and budgets. Create and maintain relevant metrics for department/site. Spreadsheets and databases will be leveraged for departmental and company metrics, presentations, and data/testing tracking/verification. The Senior Microbiologist is responsible for keeping these sheets and databases up to date. Ability to perform routine testing of samples submitted to the laboratory as appropriate. Schedules and participates in cleaning, inventory, and maintenance tasks in the lab. Supports inventory management and ordering/stocking of all QC department laboratory supplies. Ensures laboratory equipment is in compliance with procedures and GLP requirements. Troubleshoots laboratory issues related to all instrumentation. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory. Performs GMP review of test data to ensure that test results meet all specifications. Trends data and analyzes trends to proactively mitigate equipment and reagent performance issues. Verifies laboratory equipment and associated equipment logs to ensure proper operation Stakeholder: Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS). Performs routine equipment maintenance. Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary. Establishes good working relation with contract laboratories. Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ/PQ protocols. Supports activities regarding audits of suppliers and contract labs in support of vendor certification program. Conducts statistical evaluation of the manufacturing and inspection process and training QC staff. Ensure that all equipment is calibrated. Responsible to develop and validate new test procedures Perform data analysis, compile data and generate reports for management review. Review lab test data and their integrity and adherence to SOPs and cGMP. Compliance: Maintain current knowledge of regulatory and industry standards, trends and advancements. Responsible for ensuring compliance to systems and procedures in the EM/Microbiology laboratory and cleanroom areas. And prepare the lab for internal and external audits. Support Continuous Improvement initiatives by providing support on updating SOPs, WIs, and OJT Complete and maintain certified investigator training requirements. Perform investigation of the quality events assigned using root cause analysis tools, maintain timelines for closure of investigations and identify/initiate CAPAs Complete and maintain status as a certified trainer Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures Evaluates and assists in the implementation of new changes at the site, including providing training on an as needed basis Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation. Performs regular self-audits of the Microbiology and EM laboratory areas (including storage areas) and assists/leads activities to address audit findings. Stakeholder: Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations. Innovation: Supports purchasing QC EM laboratory supplies. Makes sound, well considered decisions to make the most of available funds and resources. Monitors lab supply costs and looks for ways to work with suppliers to reduce consumables cost when appropriate. Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. Makes realistic and actionable plans to address supply chain issues. Maintains the QC department ordering system to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies. Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties KNOWLEDGE, SKILLS AND ABILITIES: Education: Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology Experience: Minimum of 3+ years in a pharmaceutical environment Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently. Excellent written communication and technical writing skills. Clearly demonstrates competence in the selection and use of root cause analysis tools and techniques (e.g., 5 Whys, Pareto Analysis, 5M +E). Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks. Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs). Displays ability to achieve Glenmark Monroe QE investigator certifications for product/process/testing/facility issues with product and non-product impact. Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues. Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system. The ability to work independently and within team structure and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills. Ability to lift 30 lbs. and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions.

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 • Perform a variety of analytical laboratory testing of raw material, processed material and finished products and assure compliance with applicable laws, rules and regulations. Major Job Duties: Operate a variety of treatment test equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, hot plates, TDS, Moisture Apparatus, Melting Point, balances, etc. • Conduct a variety of analytical lab tests in compliance with standard testing methods, procedures and regulations; implement quality control specifications. Set up instruments and conduct sample tests; utilize a variety of methods to assure compliance to established standards and testing controls; interpret test results and prepare and submit reports related to test results. Perform, interpret, evaluate and record standard process control laboratory tests on ; • Perform calculations as needed and record results; notify appropriate personnel of abnormal or critical results and significant changes in lab results. Troubleshoot, clean and maintain instruments, glassware and equipment; conduct preliminary diagnostic test on equipment; assure materials meet standards of cleanliness to assure accurate test results; assure an adequate supply of test materials to perform daily testing; perform preventive maintenance on equipment. Prepare periodic and special reports concerning quality control and results of laboratory tests; prepare analytical results reports to relay qualitative and quantitative data; submit to manager of quality. • Qualifications: Essential Skills- 2 years of experience in a related laboratory. HPLC, UV- IR spectrometry, NMR, GCMS (Mass Spec, Gas Chromatography, Total Organic Carbon and etc. Technical record-keeping techniques. Perform a variety of laboratory testing. Perform mathematical calculations applicable to chemistry testing. Work cooperatively with others. Must be able to read, write, speak and understand fluent English. • Strong understanding of GMP concepts and requirements. Able to demonstrate accuracy and thoroughness while completing work in a timely manner. Follows instructions, policies, and procedures. Non-Essential Skills - Operate, maintain and repair equipment required to perform related duties. Observe health and safety regulations. Education Requirements: Bachelor's of Science degree in chemistry or closely related field. Physical Demands: While performing the duties of this job, the employee is frequently required to stand and use hands to finger, handle, or feel. The employee is occasionally required to walk; sit, talk and hear. • The employee must occasionally lift and/or move up to 50 pounds. The employee is occasionally exposed to moving mechanical parts or airborne particles. The noise level in the work environment is usually moderate. These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. Primary responsibility includes review and approval of data for the QC Microbiology lab. Including review in electronic system (i.e. LIMS) and paper systems (i.e. notebooks). Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter