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Quality control analyst jobs in North Carolina

- 287 jobs
  • QC Microbiology Analyst

    Insight Global

    Quality control analyst job in Durham, NC

    The QC Microbiology Analyst 1 role is responsible for microbiological testing. -Testing of finished product samples, stability samples, and special test requests of multiple products per standard operating procedures. -Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements. -Ensures review of laboratory testing is done in compliance with SOPs and is completed in an accurate and timely manner. -Maintains compliance with SOPs, GLP, GMP, and HSE requirements. Must Have: -Bachelor's Degree in Microbiology, Biology, Biochemistry or science related Nice to Have: -Prior microbiology testing experience -LIMS experience
    $59k-97k yearly est. 2d ago
  • Quality Control Analyst

    Apex Systems 4.6company rating

    Quality control analyst job in Charlotte, 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.
    $49k-76k yearly est. 5d ago
  • Quality Control Ananlyst

    R&D Partners

    Quality control analyst job in Holly Springs, NC

    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
    $52k-62.4k yearly 2d ago
  • Sterility Assurance Scientist

    Medasource 4.2company rating

    Quality control analyst job in Concord, NC

    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.
    $64k-87k yearly est. 1d ago
  • Sr Cust Contract QC Analyst

    Syneos Health

    Quality control analyst job in North Carolina

    Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life . Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOB SUMMARY Maintains responsibility for Quality Control of all client deliverables within the Global Deal and Contract Management (GDCM) group. Guarantees high quality of departmental output through detailed review of both contract documentation and study budgets. Ensures all deliverables conform to both client expectations and audit requirements. Provides detailed and constructive feedback to internal stakeholders and works with them to refine contractual materials. Tracks adherence to company processes and provides regular performance feedback. JOB RESPONSIBILITIES Analytically reviews budget tools and contractual materials from a Syneos Health, client and audit perspective to ensure the highest possible quality of output. Proactively works with contract analysts to refine deliverables in accordance with existing QC checklists and company policies. Evaluates all budget commentary to ensure a clear, concise and robust narrative. Assesses validity of study pricing and suitability of budgets prior to client delivery. Ensures consistency between pricing tools, budget grids, payment schedules and all contractual documentation. Utilizes QC checklists to perform a thorough review of Change Order, Change Notification Form and Ballpark documentation to ensure quality and consistency. Ensures all legal entities and defined terms are correct, appropriate and applied consistently throughout documents. Validates the presence and accuracy of inflation language if applicable. Maintains a high level of flexibility and adaptability. Proactively creates and revises priorities as the need arises whilst working toward standard cycle times of review. Supports the Change Order process through expeditious reviews and the provision of concise feedback. Identifies and raises issues before they become critical and adjusts quickly to the changes of a dynamic organization. Ensures adherence to Contract Management systems by reviewing records during the QC process. Reviews these systems to drive compliance with both GDCM and Syneos Health reporting processes and approval policies. Evaluates the performance of analysts within the GDCM group by assessing the quality of materials submitted for QC and providing performance feedback on a monthly basis. Updates and maintains departmental template and process documents. Participates in QC training for the Client Contracting Solutions group as needed. Performs other duties as assigned. QUALIFICATION REQUIREMENTS (please indicate if ‘preferred') BA/BS degree in a Business Administration or Finance with a minimum of 4 years' experience preferably in budgeting, finance, proposal development and/or contracts management within a clinical research/pharmaceutical environment; or equivalent combination of education, training and experience. Must be customer centric, self-motivated and proactive. Flexibility in responding to job demands. Have excellent problems solving skills and outstanding attention to detail. Ability to perform several tasks simultaneously to meet critical deadlines and possess strong analytical skills. Knowledge of Microsoft Excel, Word and understanding of costing models. Ability to review and interpret budgets. Ability to work successfully in a team environment and maintain effective working relationships with colleagues and manager. Demonstrates effective time management skills. Ability to prioritize multiple tasks with management guidance and oversight. Excellent interpersonal, verbal and written communication skills. Demonstrates a positive and flexible attitude toward new and/or unconventional work assignments. Ability to consistently perform and deliver a high quality work product. Excellent organizational skills. Ability to work well under pressure and adapt to changing priorities. Knowledge of clinical trial proposal process and budget management. Professional ability to interact with individuals at all levels and different personalities. Proficiency in mathematics, written language and ability to work with both budgets and text. Good interpersonal skills and ability to work well with others. Performs other duties as assigned. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $56,400.00 - $95,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
    $56.4k-95.9k yearly Auto-Apply 17d ago
  • Sr. Analyst 1, QC Analytical Development Bioassay

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Quality control analyst job in Holly Springs, NC

    The Sr. 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 Diosynth Holly Springs (FDBN). 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 Sr. 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. 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 Requirements: * B.S. 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• M.S. 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' experience in a GMP environment• Experience with QC Bioassay testing methods including protein binding assays (e.g. ELISA, Dot Blot, etc.), and• Experience with analytical method development, tech transfers and validation residual testing for DNA, Host Cell Protein (HCP), Protein A Preferred Requirements: * Master's in Virology, Microbiology, Biology or related science field with 1+ years of related experience• Experience with LIMS software 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.
    $103k-124k yearly est. Auto-Apply 60d+ ago
  • Senior QC Analyst (2nd Shift) - In-Process

    KBI Biopharma Inc. 4.4company rating

    Quality control analyst job in Durham, NC

    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.
    $63k-86.9k yearly Auto-Apply 60d+ ago
  • Sr. Analyst 1, QC Analytical Development Bioassay

    Job Listingsfujifilm

    Quality control analyst job in Holly Springs, NC

    The Sr. 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 Diosynth Holly Springs (FDBN). 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 Sr. 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. 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 Requirements: • B.S. 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 • M.S. 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' experience in a GMP environment • Experience with QC Bioassay testing methods including protein binding assays (e.g. ELISA, Dot Blot, etc.), and • Experience with analytical method development, tech transfers and validation residual testing for DNA, Host Cell Protein (HCP), Protein A Preferred Requirements: • Master's in Virology, Microbiology, Biology or related science field with 1+ years of related experience • Experience with LIMS software 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.
    $84k-108k yearly est. Auto-Apply 60d+ ago
  • Formulation Technician II - Gelatin Department C-shift - Nights

    Invitrogen Holdings

    Quality control analyst job in High Point, NC

    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, Loud Noises (Equipment/Machinery), Will work with hazardous/toxic materials 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: Necessary: 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
    $33k-55k yearly est. Auto-Apply 11d ago
  • Sr Cust Contract QC Analyst

    Syneos Health, Inc.

    Quality control analyst job in Morrisville, NC

    Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOB SUMMARY Maintains responsibility for Quality Control of all client deliverables within the Global Deal and Contract Management (GDCM) group. Guarantees high quality of departmental output through detailed review of both contract documentation and study budgets. Ensures all deliverables conform to both client expectations and audit requirements. Provides detailed and constructive feedback to internal stakeholders and works with them to refine contractual materials. Tracks adherence to company processes and provides regular performance feedback. JOB RESPONSIBILITIES * Analytically reviews budget tools and contractual materials from a Syneos Health, client and audit perspective to ensure the highest possible quality of output. Proactively works with contract analysts to refine deliverables in accordance with existing QC checklists and company policies. * Evaluates all budget commentary to ensure a clear, concise and robust narrative. Assesses validity of study pricing and suitability of budgets prior to client delivery. Ensures consistency between pricing tools, budget grids, payment schedules and all contractual documentation. * Utilizes QC checklists to perform a thorough review of Change Order, Change Notification Form and Ballpark documentation to ensure quality and consistency. Ensures all legal entities and defined terms are correct, appropriate and applied consistently throughout documents. Validates the presence and accuracy of inflation language if applicable. * Maintains a high level of flexibility and adaptability. Proactively creates and revises priorities as the need arises whilst working toward standard cycle times of review. Supports the Change Order process through expeditious reviews and the provision of concise feedback. Identifies and raises issues before they become critical and adjusts quickly to the changes of a dynamic organization. * Ensures adherence to Contract Management systems by reviewing records during the QC process. Reviews these systems to drive compliance with both GDCM and Syneos Health reporting processes and approval policies. * Evaluates the performance of analysts within the GDCM group by assessing the quality of materials submitted for QC and providing performance feedback on a monthly basis. * Updates and maintains departmental template and process documents. * Participates in QC training for the Client Contracting Solutions group as needed. * Performs other duties as assigned. QUALIFICATION REQUIREMENTS (please indicate if 'preferred') BA/BS degree in a Business Administration or Finance with a minimum of 4 years' experience preferably in budgeting, finance, proposal development and/or contracts management within a clinical research/pharmaceutical environment; or equivalent combination of education, training and experience. Must be customer centric, self-motivated and proactive. Flexibility in responding to job demands. Have excellent problems solving skills and outstanding attention to detail. Ability to perform several tasks simultaneously to meet critical deadlines and possess strong analytical skills. Knowledge of Microsoft Excel, Word and understanding of costing models. Ability to review and interpret budgets. Ability to work successfully in a team environment and maintain effective working relationships with colleagues and manager. Demonstrates effective time management skills. Ability to prioritize multiple tasks with management guidance and oversight. Excellent interpersonal, verbal and written communication skills. Demonstrates a positive and flexible attitude toward new and/or unconventional work assignments. Ability to consistently perform and deliver a high quality work product. Excellent organizational skills. Ability to work well under pressure and adapt to changing priorities. Knowledge of clinical trial proposal process and budget management. Professional ability to interact with individuals at all levels and different personalities. Proficiency in mathematics, written language and ability to work with both budgets and text. Good interpersonal skills and ability to work well with others. * Performs other duties as assigned. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $56,400.00 - $95,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Maintains responsibility for Quality Control of all client deliverables within the Global Deal and Contract Management (GDCM) group. Guarantees high quality of departmental output through detailed review of both contract documentation and study budgets. Ensures all deliverables conform to both client expectations and audit requirements. Provides detailed and constructive feedback to internal stakeholders and works with them to refine contractual materials. Tracks adherence to company processes and provides regular performance feedback
    $56.4k-95.9k yearly 18d ago
  • Quality Control Chemist

    Actalent

    Quality control analyst job in Greensboro, NC

    The Quality Control Chemist is responsible for conducting wet analyses and physical testing of in-process chemical samples, ranging from raw materials to finished DEET products. The chemist will confidently utilize instruments such as HPLC, GC, Flame AA, KF, and perform titrations. The role involves interpreting, computing, recording, and reporting all test data to production and other relevant personnel using LabWorks. Promptly alerting production and quality management of any suspect test data or deviations is crucial. Responsibilities + Perform wet analyses and physical testing of in-process chemical samples using standard techniques. + Utilize instruments including HPLC, GC, Flame AA, KF, and conduct titrations. + Interpret, compute, record, and report test data using LabWorks. + Alert production and quality management of suspect test data or deviations. + Calibrate and maintain analytical equipment as instructed by lab management. + Prepare laboratory reagents, standards, and mobile phases as instructed by lab management. Essential Skills + Proficiency in GMP, analytical chemistry, and quality control processes. + Experience with GC, HPLC, and titrations (manual and automated). + Strong analytical and problem-solving skills. + Ability to work independently with minimal supervision. Additional Skills & Qualifications + Experience in wet chemistry within a chemical manufacturing facility. + Proficiency with Microsoft Office. + Associate degree in Chemistry or another science-related field preferred. Work Environment The position is based in an older but updated lab, focused on in-process product testing directly from chemical operators. The environment is fast-paced, performing 120 tests per shift with over 300 methods. The lab follows standardized procedures aligned with regulatory agencies, and no R&D is conducted. The shift is 12 hours, from 7pm to 7am, with initial training on the first shift for 2-3 weeks. Long-term opportunities are contingent on the product line's sales performance. Job Type & Location This is a Contract to Hire position based out of Greensboro, NC. Pay and Benefits The pay range for this position is $24.00 - $27.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Greensboro,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.
    $24-27 hourly 4d ago
  • Microbiology Analyst ll

    Microbac Laboratories, Inc. 4.0company rating

    Quality control analyst job in Wilson, NC

    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.
    $38k-58k yearly est. Auto-Apply 60d+ ago
  • Quality Control Chemist

    Mindlance 4.6company rating

    Quality control analyst job in Rocky Mount, NC

    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.
    $51k-64k yearly est. 23h ago
  • QC Chemist

    Artech Information System 4.8company rating

    Quality control analyst job in Rocky Mount, NC

    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 ************
    $51k-67k yearly est. 23h ago
  • QC Chemist

    Us Tech Solutions 4.4company rating

    Quality control analyst job in Rocky Mount, NC

    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
    $48k-65k yearly est. 23h ago
  • Senior Microbiology Analyst

    Glenmark Pharmaceuticals

    Quality control analyst job in Monroe, NC

    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.
    $37k-56k yearly est. 60d+ ago
  • Quality Control Chemist

    Global Channel Management

    Quality control analyst job in Sanford, NC

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Analytical Chemist needs 2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry Analytical Chemist requires: BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry Experience in the biotech or pharmaceutical industry Analytical Chemistry and/or Microbiology techniques and instrumentation, Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel Analytical Chemist responsibilities include: Performs tasks associated with maintaining GMP compliant Quality Control and Stability laboratories with a specific focus on Performs testing including, but not limited to clinical and/or commercial standards/controls/critical reagents, product, raw materials and validation samples. Additional Information $26HR 6 Months
    $26 hourly 23h ago
  • QC Chemist

    Us Tech Solutions 4.4company rating

    Quality control analyst job in Rocky Mount, NC

    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
    $48k-65k yearly est. 60d+ ago
  • Senior Microbiology Analyst

    Glenmark Pharmaceuticals Inc.

    Quality control analyst job in Monroe, NC

    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.
    $37k-56k yearly est. 60d+ ago
  • QC Chemist

    Artech Information System 4.8company rating

    Quality control analyst job in Sanford, NC

    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
    $50k-66k yearly est. 60d+ ago

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