Quality control analyst jobs in Wilmington, NC

Apex Systems is currently hiring for an Quality Control with one of our large Banking clients. Onsite expectation: 4 days onsite per week Pay range: 22-28/HR Note: We are unable to consider C2C or third-party submissions. Qualified candidates will have the following experience and skills: Quality control around documentation Plus: Knowledge of Treasury and/or Legal Documentation Job Description: Quality Control for Treasury Products & Services Packages Follow procedures Attention to detail. Working closely with internal teams in services and fulfillment. Previous Experience in Quality Control position required Key Skills: Will be supporting existing associates and working with internal teams Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet' as well, which an Apex team member can provide. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at ******************************** or ************. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

R&D Partners is seeking to hire a Quality Control Analyst in Holly Springs, NC. Your main responsibilities as a Quality Control Analyst: Performs testing and associated tasks without errors per applicable SOPs and protocols within Immunology/Biochemistry function. Properly documents test results in appropriates records and computer systems Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written. Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs. Participates and performs in cross-training to support staff availability within QC department. What we are looking for in a Quality Control Analyst: Bachelor's degree (Biochemistry preferred, recent graduates ok) 1+ years of laboratory experience (ok if degree related) Knowledge of analytical methods and related instrumentation (ok if academic) Must already have or be willing to get a flu shot 1+ years of GMPs safety regulations and data integrity is preferred Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance - PPO, HMO & Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability Weekly payroll Expense reimbursement Online timecard approval Pay Scale: $52,000 - $62,400 Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page. R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - ******************************************* Desired Skills and Experience BS Biochemistry, or related. Knowledge of analytical methods and instrumentation, ELISA, BCA, SRID, SDS-PAGE

Title: Sterility Assurance Scientist Duration: 6 Month Contract (potential of extension) Responsibilities: The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance contamination control strategies are established. Key Objectives/Deliverables • (Associate/Senior) Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level. • Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to: • Airflow Pattern Testing • Environmental Monitoring Performance Qualifications • Aseptic Process Simulations • Cleaning, Sanitization, and Disinfection • Gowning within GMP Classified Areas • Aseptic Processing Techniques • Contamination Control • Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established. • (Senior) Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established. • (Senior) Lead/assist with support and/or provide technical expertise for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies. • (Senior) Lead/assist with support and/or provide technical expertise for the facility's cleanroom gowning and aseptic technique strategy/program. • (Principal) Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification. • (Principal) Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program: • (EM) Authoring EM Performance Qualifications (EM PQ) and overseeing the execution. • (EM) Evaluating EM data and authoring EM Trend Reports. • (EM) Assist with identifying facility environmental isolates and how to create and maintain environmental isolated cultures. • (APS) Authoring APS protocols and overseeing the execution. • (APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports. • (APS) Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process. • Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination. • Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements.• Lead or provide technical support for root cause investigations associated with sterility assurance programs. • Participate and/or provide technical sterility assurance support during internal and external audits. • Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs. • Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives. Basic Qualifications: • Bachelor's or master's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline. • Demonstrated understanding and relevant experience of scientific principles required for manufacturing parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing. • (Senior) 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept). • (Principal) 5+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept). Additional Skills/Preferences: • Possess strong interpersonal skills to work cross-functionally within a team. • Possess strong self-management and organizational skills. • Possess strong oral and written communication skills for communicating to colleagues, management, and other departments. • Experience with data analysis and trending. • Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing warehouse, or laboratory areas. • Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities. Additional Information: • Role is Monday through Friday based and will be phased from a project support role to a routine support role as the development facility and processes progress. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or off-hour work may be required. • Tasks may require repetitive motion and standing or walking for long periods of time. • Travel may be required during the project phase for training and implementation of sterility assurance programs. This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Human Technologies, Inc. has multiple openings for Quality Control Chemists with a large pharmaceutical manufacturing company located in Greenville, SC. These are direct-hire, full-time, onsite positions. Our client company offers a competitive benefits package and strong opportunities for growth and advancement. Salary range: $55,000 - $65,000/year, depending on experience Shifts available: First shift: Mon-Fri 7am-4:30pm Second shift: Mon-Fri 4pm-2:30am REQUIREMENTS: Must currently reside in the Greenville, SC area Must have Bachelor's degree in Chemistry or Biology Must have 1+ year of recent chemistry lab experience, including HPLC experience (college lab courses and/or work experience) Training or experience in chromatographic software, instrument troubleshooting, and titrations/wet chemistry experience are preferred. Experience in an FDA-regulated manufacturing industry is a plus. Strong written and verbal communication skills. Must be authorized to work in the United States without visa sponsorship (now and in the future). JOB DUTIES: Analyze raw materials, stability samples, and finished products to ensure they meet all quality and compliance requirements. Accurately follow all established SOP's/processes and safety procedures. HPLC and GC methodology and analyses, including preparations (extractions, dissolution, ISE separation, etc.) Titrations, USP/NF limit tests, identifications, TLC, etc. Accurately document all test/analysis data in a timely manner; perform reviews of laboratory documentation. Testing and release of manufactured bulk products for packaging. Assist with inventory of required lab materials. Maintain a clean and safe workspace. Equal Opportunity Employer

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Scientist I (QC Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist I (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company). On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Performs one or more of the following techniques: assays, potencies, pH, TOC, moisture content, identification, particle size, and various other wet chemistry and instrument-based measurements. Evaluates and interprets generated data. Analyzes information for technical correctness and accuracy. Understands the theoretical basis of methods/experiments. Performs technical review of common laboratory data. Maintains laboratory stock of reagents, clean glassware, and removes expired solutions. Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks. Assists in removal of hazardous waste, routine equipment cleaning and restocking of consumable products and reagents. Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.). Maintains a safe, clean, and organized work environment free of safety hazards. Safely handles potent compounds. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Chemistry, Biochemistry, or a related field with course work in Chemistry with 2+ years related work experience. Or Associates degree in Chemistry or related field with 6+ years related experience. Knowledge, Skills, and Abilities Good verbal and written communication and documentation skills required. Good detail orientation and organizational skills required. Good problem-solving and basic trouble-shooting ability required. Strong knowledge of Laboratory equipment and safety required. Strong knowledge of Laboratory Documentation is required. Working knowledge of cGMP in a pharmaceutical or regulated environment preferred. Proficiency with Microsoft Office (Word, Excel, PowerPoint) required. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment 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. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk, sit, climb, or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, half face and full-face respirator, lab coats, full protective body coverings, various types of gloves, etc.

Acute Care TechnologySee attached Job Description At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won't just have a job. You'll have a career-and a purpose. Join our team. It's a great time to be a part of ZOLL! Job Summary Verification of procured materials, sub-assemblies, finished products and processes to the companies Quality Standards. This may include visual inspection, dimensional measurement, and electrical testing to verify conformance to established standards and specifications. Essential Functions Inspect measure and/or test material to established methods and standards. Utilize various inspection tools, such as Vision System, Verniers, Micrometers, Rulers, Oscilloscopes, DVMs, Power Supplies, Defib/Pacer Analyzers, custom fixtures etc. per procedures. Document inspection and test results according to established procedures. Maintain quality documentation files such as, Device History Records (DHR) and Inspection History Records. Process returned material to established procedures. Read and interpret documentation such as Standard Operating Procedures (SOP), schematics, technical drawings, PDAs and ECOs. Interface with other functions and departments as required. Required/Preferred Education and Experience High School Diploma Or equivalent. required 1-3 years experience in a related position. required Knowledge, Skills and Abilities Good written and oral communication skills. Ability to read specifications, procedures and engineering drawings. Familiar with use of mechanical and electronic test equipment. IPC-A-61OD for Incoming Inspection, preferred. Basic computer skills: Microsoft Office, Oracle and MES. Physical Demands Ability to lift up to 50 lbs. ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. #LI-LV1 The hourly pay rate for this position is: $24.00 to $25.00 Factors which may affect this rate include shift, geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at ********************* Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

Acute Care TechnologySee attached Job Description At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won't just have a job. You'll have a career-and a purpose. Join our team. It's a great time to be a part of ZOLL! Job Summary Verification of procured materials, sub-assemblies, finished products and processes to the companies Quality Standards. This may include visual inspection, dimensional measurement, and electrical testing to verify conformance to established standards and specifications. Essential Functions * Inspect measure and/or test material to established methods and standards. * Utilize various inspection tools, such as Vision System, Verniers, Micrometers, Rulers, Oscilloscopes, DVMs, Power Supplies, Defib/Pacer Analyzers, custom fixtures etc. per procedures. * Document inspection and test results according to established procedures. * Maintain quality documentation files such as, Device History Records (DHR) and Inspection History Records. * Process returned material to established procedures. * Read and interpret documentation such as Standard Operating Procedures (SOP), schematics, technical drawings, PDAs and ECOs. * Interface with other functions and departments as required. Required/Preferred Education and Experience * High School Diploma Or equivalent. required * 1-3 years experience in a related position. required Knowledge, Skills and Abilities * Good written and oral communication skills. * Ability to read specifications, procedures and engineering drawings. * Familiar with use of mechanical and electronic test equipment. * IPC-A-61OD for Incoming Inspection, preferred. * Basic computer skills: Microsoft Office, Oracle and MES. Physical Demands * Ability to lift up to 50 lbs. ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. #LI-LV1 The hourly pay rate for this position is: $24.00 to $25.00 Factors which may affect this rate include shift, geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at ********************* Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

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.

Hourly Rate: Depending on Experience. About Us: We are a veteran owned contractor, providing project, maintenance, and outage support throughout the United States. Over the past 15 years we have proven to be a trusted partner for our clients while providing services that help power the world. Summary: We are looking for a skilled QA/QC lead. All applicants must be familiar with ASME Boiler and Pressure Vessel Code, welding processes, SMAW, GTAW and FCAW. Must be familiar with NDT methods, visual, magnetic particle, liquid penetrant, radiography experience helpful. Responsibilities: • Performs process/product quality evaluations, conducts special studies and projects as requested by Quality Engineers. • Investigates and recommends solutions to quality data collection systems problems. • Performs Product/Material certification activities. • Controls release and status of acceptable, suspect, and non-conforming material and products. • Responsible for the development and maintenance of QA record Retention Systems. • Must be able to work with minimal supervision and make independent sound judgments. • Must be able to perform detailed mechanical and visual inspections as required. • Perform Dedication activities per specifications, drawing or test plans on commercial grade products to upgrade to nuclear grade material. • Responsible for implementing QA requirements contained in Quality Planning, Engineering specifications, Order Entry • Documentation, Purchase Orders and applicable regulatory requirements. • Responsible for dedication inspection/testing of product and certifying this activity. • Provides accurate and timely data analysis to support requests from customer, supplier, or Engineering. • Periodically interacts with internal/external auditors, customers, and suppliers. Must establish and maintain effective working relationships with individuals, auditors, managers, suppliers, and customers. • Capable of performing complex inspections and tests on product and material using standard and special gages. • Other duties as assigned. Qualifications: • Proficient with standard computer software (MS Word and Excel) and be able to write detailed inspection reports while maintaining an organized system of files. • Must have basic understanding of statistics, algebra and trigonometry. • Must have a minimum of 1-year experience in the nuclear industry with a working knowledge of the requirements of 10CFR50, Appendix B and ANSI N45.2.. • Must be certified in the following: ANSI N45.2.6 Level II, MT & PT Level II and VT-1 Level II. • Self-motivated with good written and verbal communication skills with a positive team-oriented attitude is required. • Must have reliable transportation and be able to travel extensively with an unrestricted driver's license. • Must pass background screens and drug/alcohol testing as required by our customers, including randoms. • Non - US Citizens must hold current work visa or green card. • High School Diploma or GED Preferred Qualifications: (not required) • Minimum of 5 years' experience in Quality Assurance or Quality Control Activities. • Minimum of 5 years' experience in fabrication, welding, manufacturing or related field. • Minimum of 5 years' experience in Mechanical/Dimensional inspection. Physical Requirements: • Must be able to work in heightened environments. • Must be able to carry 20lbs. • Must be able to push, pull, lift, climb, and extend as required for the job. • Must be able to work in high heat environments. • Able to stand, bend & kneel for extended periods of time. • Able to lift 50lbs. • Able to work in a confined space/ highly congested work area. • Able to wear full body protective clothing, to include face shield. • Able to work in radiation control areas.

Work Schedule Rotating schedule from 7pm - 7am Job Description Join the Thermo Fisher Scientific team to contribute to global impact through meaningful work. Support our Mission daily to empower customers in creating a healthier, cleaner, and safer world. Location/Division Specific Information: Within the Pharma Services Group (PSG), the High Point, NC location specializes in gelatin-based drug delivery dosage forms (softgels). Our expertise lies in the development and production of various softgel technologies. How Will You Make an Impact? The Formulation Technician II will be responsible for operating an encapsulating machine to produce products from pre-mixed ingredients, ensuring accurate temperatures, machine settings, equipment set-ups, in-process measurements, and quality product. A Day in the Life: Manufacture simple, bulk products Observe machine operation, adjust as needed, take samples of product, and perform in-process testing Assist Set-Up person to set up machine, empty basket, clean and prepare machine for changeover, and assist with the actual changeover Assist with cleanup and other encapsulation duties as needed Operate inline printing equipment Education: High school diploma or equivalent experience required. Experience: At least 1 year of professional experience in a manufacturing, operations, production, or lab environment or a relevant field Desired: Background in a cGMP setting Knowledge, Skills, Abilities: Excellent verbal and written skills Ability to interpret data, perform basic calculations, and troubleshoot Ability to work a 12-hour shift in a 24-hour, 7 day per week operation Meet DEA security clearance requirements if requested Must have the flexibility to work additional hours when needed Physical Requirements / Work Environment: Must have the ability to regularly lift, push, pull, or transport items weighing up to 50 pounds Adherence to all GMP Safety Standards Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed Loud noises (equipment/machinery) Some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.) Standing for full shift Working at heights What We Offer Compensation: Competitive hourly pay rate Additional shift differential for night shift positions Annual performance-based bonus Annual merit performance-based increase Excellent Benefits! Medical, Dental, & Vision benefits effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement 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.

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 ************

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.

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. 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.

The Lab Technologist III will process and analyze patient samples, monitor quality control, ensure all instruments are properly maintained, and enter patient results in their department. This position may require conducting training for new employees and ensuring regulatory compliance standards are met. Responsibilities + Read and follow Departmental Standard Operating Procedures (SOPs). + Judge the acceptability of quality control results with proficiency. + Communicate sample issues within and outside the department to ensure proper client communication. + Participate in internal and external proficiency testing. + Perform maintenance on departmental equipment with proficiency. + Perform, interpret, and troubleshoot assays with proficiency. + Assist in the evaluation and development of new procedures. + Achieve training goals as established by Human Resources. + Understand and follow all safety rules and regulations. + Apply value statements and quality principles to work. + Assist supervisors in daily department operations. + Perform daily, weekly, and monthly maintenance on all department instruments. + Participate in training new employees. + Work closely with other lab personnel. + Assist in research projects as needed. + Assist in maintaining adequate supplies in the department. Essential Skills + Proficiency in clinical microbiology testing/assays at a major hospital or research institution. + Experience with blood, wound, and urine cultures, and microbial identification using various techniques such as bench biochemicals, Vitek, and MALDI-ToF. + Parasitology microscopic analysis and identification, including trichrome and concentrate preparations. + Bachelor's Degree in a Biological or Chemical Science, Medical Technology, or MLT Certification. + Competency in multiple assays and routine issue troubleshooting. + Ability to train others on sample analysis. + Problem-solving skills, detail-oriented, self-motivated, and teamwork. Additional Skills & Qualifications + Must pass a colorblind test for the Microbiology position. + Minimum of 6 years of clinical laboratory training or experience post-MLT degree. + Minimum of 4 years of clinical laboratory training or experience post-MT or BS degree. + Leadership potential within 18-24 months, with potential for advancement to Assistant Technical Supervisor. Work Environment Work in a CLIA-certified clinical diagnostics laboratory. You will be part of a pioneering team dedicated to advancing personalized healthcare. The collaborative culture values innovation, diversity, and inclusion, and supports professional growth through ongoing training and mentorship programs. Job Type & Location This position is based out of North Carolina. Job Type & Location This is a Permanent position based out of Asheville, NC. Pay and Benefits The pay range for this position is $43680.00 - $62400.00/yr. Benefits would be available to them after they complete their time through protouch and would have a waiting/probationary period of 60 days once they are a Genova employee. Once they meet their 60-day waiting period with Genova they are eligible for health, dental, and vision benefits. We offer PPO and HDP plans through Aetna. After 90 days of employment through Genova you are eligible for 401k. There is an employer contribution. For each dollar you contribute, Genova will match dollar for dollar up to a maximum of 3% and $0.50 on the dollar for the next 2% of compensation. That is 100% vested. Vacation- When employees are hired, they begin accruing vacation at a rate of 3.08 hours per pay period and up to 80 hours per year. Personal Leave- Employees will receive personal leave after 6 months of employment. Full time employees will receive 40 hours. Holidays-After 60 days employees are eligible for paid holidays. The company's seven paid holidays are: New Year's Day, Easter, Memorial Day, July 4th, Labor Day, Thanksgiving, Christmas. Workplace Type This is a fully onsite position in Asheville,NC. Application Deadline This position is anticipated to close on Jan 7, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Work Hours: 8:30am-5:00pm or 3:00pm-11:30pm Monday-Friday Training Hours: 8:30am -:00pm or 3:00pm-11:30pm Monday - Friday The Lab Technologist will process and analyze patient samples, monitor QC, ensure all instruments are maintained properly, and report patient results in their department. This position requires a Bachelor's Degree in Biological or Chemical Science or MLT Certification. Upon hire candidates must provide official transcripts and a copy of their diploma. No previous professional experience is required however prior clinical experience is desirable. Candidates must be an excellent problem solver, detail oriented, self-motivated, and a good team player. You must successfully past a colorblind test. The employee must be able to work in an environment containing biohazards, toxic chemicals, pungent odors, corrosive acids, noise, sharp objects, and other normal hazards found in the clinical laboratory. Laboratory safety measures are in place and protective equipment provided to help minimize possible exposure to these environmental risks.

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.

The Lab Technologist is responsible for processing and analyzing patient samples, ensuring quality control, maintaining instruments, and entering patient results. This role requires experience and training in the relevant department and may involve conducting training for new employees. The position demands close collaboration with departmental staff to maintain effective workflow and meet regulatory compliance standards. Responsibilities + Read and follow Departmental Standard Operating Procedures (SOPs). + Demonstrate proficiency in performing, interpreting, and troubleshooting assays. + Judge the acceptability of quality control results. + Participate in internal and external proficiency testing. + Review work for accuracy prior to releasing to clients. + Communicate sample issues within and outside the department for proper client communication. + Assist in the evaluation and development of new procedures. + Achieve training goals as established by Human Resources. + Assist supervisors in daily departmental operations. + Perform maintenance on department equipment. + Collaborate with other departmental personnel and the Product Development Department. + Maintain adequate supplies in the department. + Participate in training new employees. + Assist in maintaining year-round inspection readiness. + Understand and follow all safety rules and regulations. + Apply company value statements and Quality Principles to work. + Assist in research projects as needed. Essential Skills + Proficiency in laboratory assays, specifically clinical microbiology testing. + Experience with blood, wound, and urine cultures, and microbial identification using techniques such as bench biochemicals, Vitek, and MALDI-ToF. + Parasitology microscopic analysis and identification. + Competency in PCR, DNA extraction, and molecular biology techniques. + Ability to troubleshoot routine issues and train others in sample quantification. Additional Skills & Qualifications + Bachelor's or Master's Degree in a Biological or Chemical Science, or a degree in Medical Technology. + If MLT degree must have 6 years of subsequent clinical laboratory training or experience. + If MT degree must have 4 years of subsequent clinical laboratory training or experience. + If BS degree must have 4 years of subsequent clinical laboratory training or experience. + Successful completion of a colorblind test for microbiology positions. + Strong supervisory skills and leadership potential. Work Environment This position is based in a CLIA-certified clinical diagnostics laboratory. The work environment requires meeting educational requirements and involves working in a facility dedicated to advancing personalized healthcare. The lab fosters a collaborative culture that encourages innovation and professional growth. The role supports professional development with ongoing training, mentorship programs, and opportunities for career advancement. Job Type & Location This is a Permanent position based out of Asheville, NC. Pay and Benefits The pay range for this position is $52000.00 - $79040.00/yr. Benefits would be available to them after they complete their time through protouch and would have a waiting/probationary period of 60 days once they are an employee. Once they meet their 60-day waiting period with the company they are eligible for health, dental, and vision benefits. We offer PPO and HDP plans through Aetna. After 90 days of employment you are eligible for 401k. There is an employer contribution. For each dollar you contribute, we will match dollar for dollar up to a maximum of 3% and $0.50 on the dollar for the next 2% of compensation. That is 100% vested. Vacation- When employees are hired, they begin accruing vacation at a rate of 3.08 hours per pay period and up to 80 hours per year. Personal Leave- Employees will receive personal leave after 6 months of employment. Full time employees will receive 40 hours. Holidays-After 60 days employees are eligible for paid holidays. The company's seven paid holidays are: New Year's Day, Easter, Memorial Day, July 4th, Labor Day, Thanksgiving, Christmas. Workplace Type This is a fully onsite position in Asheville,NC. Application Deadline This position is anticipated to close on Dec 10, 2025. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.