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Quality Control Analyst jobs at Eurofins - 418 jobs

  • QC Medical Packaging Scientist

    Eurofins Us Network 4.4company rating

    Quality control analyst job at Eurofins

    Indianapolis, IN, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. **Job Description** + Perform evaluations and laboratory testing on primary container-closure components and system, critical secondary packaging, and shipping systems utilizing mechanical testing equipment, dimension measurement instruments, and container closure integrity testing systems + Execute methods, collect data, and document results in lab notebooks and LIMS + Participate in the development of laboratory test methods or equipment to ensure reliability and accuracy of results + Interact with colleagues in other groups on a routine basis + Ensure all activities follow established safety standards, regulatory requirements and Good Manufacturing Procedures (GMP **Qualifications** + Bachelor's in science, engineering, or technology, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major) + At least 2-4 years related laboratory experience **Additional Information** + The position is full-time, Monday through Friday, 8 a.m. to 5 p.m., with overtime as needed. Candidates currently living within a commutable distance of **Indianapolis, IN,** are encouraged to apply. + Ability to work overtime as required. + Tasks require repetitive motion and standing for long periods of time. + May be required to respond to off-shift operational issues. + Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options + Life and disability insurance + 401(k) with company match + Paid vacation and holidays + **\#LI-EB1** + Authorization to work in the United States indefinitely without restriction or sponsorship **Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
    $51k-84k yearly est. 10d ago
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  • Sr. Microbiologist

    Neilmed Pharmaceuticals 4.0company rating

    Santa Rosa, CA jobs

    NeilMed (Santa Rosa, CA) takes pride in delivering quality OTC products from development through manufacturing. We're looking for a Senior Microbiologist to join our team and be the subject-matter expert for microbiological control across our manufacturing, QC and operations functions. Responsibilities Lead and execute advanced microbiology testing of raw materials, in-process samples, finished goods, packaging materials, and utilities in support of OTC drug manufacturing. Drive and oversee the environmental monitoring program (clean-rooms, production areas, utilities) and ensure microbiological integrity of the manufacturing environment. Investigate microbiological failures and out-of-specification (OOS) results; perform root-cause analysis and lead corrective & preventive actions (CAPA). Develop/validate microbiological methods (e.g., microbial enumeration, microbial limits, preservative efficacy, endotoxin/bioburden, sterility if applicable) aligned with compendial standards (USP/EP) and regulatory requirements for OTC drugs. Write and review protocols, reports, deviations, CAPAs, trend analyses, change controls and SOPs relevant to microbiology. Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D and Engineering to create and maintain microbiological control strategies across the product/process lifecycle. Monitor and analyze microbial trend data and recommend improvements to facility/processes for risk mitigation and continuous enhancement. Provide technical leadership and mentorship to junior microbiologists/technicians; promote a culture of excellence, data integrity and continuous improvement. Support internal audits, external inspections, supplier/contract-lab evaluations as required. Maintain strict adherence to cGMP, GLP, Good Documentation Practice (GDP), and data integrity standards in the lab and manufacturing environment. Qualifications Required: Bachelor's degree in Microbiology, Biology or a closely related science (Master's/PhD preferred). 5-10+ years' experience in microbiology within a pharmaceutical/OTC drug manufacturing environment (or similarly regulated manufacturing). Hands-on experience with microbiological methods: bioburden, endotoxin, sterility (if applicable), preservative efficacy, microbial identification, environmental monitoring (air, surfaces, utilities). Familiarity with 21 CFR 210/211, OTC monographs, FDA inspections, compendial guidelines such as USP, etc. Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root-cause resolution. Strong leadership, communication and interpersonal skills; ability to train and mentor team members and influence cross-functional stakeholders. Strong organizational skills, meticulous attention to detail, ability to prioritize tasks and meet manufacturing-driven timelines (including some flexibility for after-hours/weekend support). Proficiency with LIMS and statistical/data review tools; comfort working in a manufacturing laboratory environment with microbiological cultures, incubators, etc. Preferred Skills Experience in vertically-integrated manufacturing operations (raw material → finished goods) and understanding of upstream/downstream impact of microbiology. Demonstrated track record supporting regulatory inspections or audits (e.g., FDA). Experience working in an OTC or consumer health product environment. Strong analytical and problem-solving mindset; ability to influence process improvements based on microbial trend data. Self-starter attitude and ability to work autonomously within a cross-functional team in a fast-paced manufacturing setting. Pay range and compensation package We offer a competitive benefits package including medical/dental/vision. Retirement plan. Paid time off. Opportunities for professional development. 50k Life Insurance Policy (paid by Neilmed).
    $87k-132k yearly est. 3d ago
  • Formulation Technician I

    STAQ Pharma Inc. 3.7company rating

    Columbus, OH jobs

    This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required. Hours of Work: 8-hour shift Monday through Friday. 0600-1430 or 1400-2230. Safety and Responsibilities SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for filling operations. Responsible for acquiring and maintaining classified area gowning qualification. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Values and Behaviors Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. Required Qualifications and Education High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Preferred Skills Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability. 10am - until work is complete
    $34k-43k yearly est. 7d ago
  • Formulation Technician I

    PCI Pharma Services 4.1company rating

    Bedford, NH jobs

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company. **Schedule:** Sunday - Wednesday 6:00AM - 4:30PM **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. + Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed + Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss + Initiate the production of batch documentation used for engineering and cGMP production. + Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes + Complete executed Batch Records accurately and completely prior to submission to supervision for review + Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements + Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions + Cross train to increase technical skills across the department + Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements. + As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed. + Work with enabling groups to improve/implement processes. + Other duties as assigned. + Strong interpersonal skills + Strong working knowledge of MS Office suite is preferable + Attention to detail and positive attitude are key attributes + Able to follow rules and regulations perfectly + Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Required:** + High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred + Experience and knowledge of formulation/compounding tools and equipment + Minimum 1-2 year's work experience in a GMP environment preferably in fill finish pharmaceutical operations + Demonstrated ability to prioritize multiple projects and activities Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. \#LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
    $42k-55k yearly est. 49d ago
  • Sr. Quality Control Analyst

    Environmental Science 3.7company rating

    Waltham, MA jobs

    Shift: Monday through Friday, 8:00 AM - 4:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. SUMMARY Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions. NOTE: This is an EVERGREEN posting where we are collecting candidates for a future role Compensation: $35.00 - 50.00 per hour ESSENTIAL FUNCTIONS Serves as a lead to staff to include providing work direction, guidance, and training. Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information. Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing. Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients. Provides training and guidance on analytical tests, methods, and instrumentation, as required. Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients. Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients. Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others. Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment. QUALIFICATIONS Education and Experience Bachelor's degree in chemistry/biochemistry, or a closely related field. Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred. Required Knowledge and Skills Required Knowledge Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development. Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures. Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns. Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations. Understanding of broad testing tools, equipment, and calibration. Computer applications and systems related to the work. Principles and practices to serving as an effective project team member. Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations. Correct business English, including spelling, grammar, and punctuation. Required Skills Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas. Overseeing and administering broad and varied chemistry/biochemistry/formulation functions. Ability to operate and train others in analytical instruments and manufacturing equipment. Training others in policies and procedures related to the work. Serving as a team member and the development and management of projects. Operating in a both a team and individual contributor environment. Interpreting, applying, and explaining applicable laws, codes, and regulations. Preparing advanced to expert functionals reports, correspondence, and other written materials. Using initiative and independent judgment within established department guidelines. Using tact, discretion, and prudence in working with those contacted during the work. Performing effective oral presentations to large and small groups across functional peers and the department. Contributing effectively to the accomplishment of team or work unit goals, objectives and activities. Establishing and maintaining effective working relationships with various individuals contacted in the work. Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $35-50 hourly Auto-Apply 60d+ ago
  • Sr. Analyst, QC Analytical

    Revance 4.2company rating

    Newark, CA jobs

    The Senior Lead Analyst in Analytical Quality Control serves as a technical expert in complex analytical testing and instrumentation, providing leadership, mentorship, and project management for quality control activities within a cGMP environment. This role is a high-level individual contributor position that bridges technical expertise with leadership responsibilities, ensuring product quality, compliance, and data integrity within a biopharma manufacturing organization. * Reporting to: Associate Director, Quality Control Analytical * Location: Newark, CA * Salary Range: $115k - $130k + Bonus * The final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education, and geographic location. Responsibilities/Essential Duties: * Analytical Testing: Performing and reviewing complex analytical tests for raw materials, in-process samples, and finished products using techniques such as HPLC, UPLC, LCMS, ELISA, CE-SDS, and various compendial methods. * Documentation and Compliance: Authoring, reviewing, and approving GMP documentation, including SOPs, test methods, protocols, technical reports, and quality records (deviations, OOS, CAPAs, Change Controls). Ensuring all activities adhere to cGMP and GLP. ICH, FDA, and EMA guidelines. * Troubleshooting and investigation: Acting as a subject matter expert (SME) to troubleshoot complex equipment and method issues, and leading thorough investigations into out-of-specification (OOS) or out-of-trend (OOT) results using root cause analysis tools. * Method Lifecycle Management: Leading and supporting the development, optimization, transfer, qualification, and validation of analytical methods for new and existing products. * Leadership and Training: Mentoring and training junior analysts, guiding staff in laboratory procedures, and potentially managing day-to-day team activities and resource allocation. * Project and Cross-Functional Collaboration: Leading projects and collaborating with cross-functional teams such as Manufacturing, Quality Assurance, Regulatory, and Analytical Development to meet deliverables and support regulatory inspections. Basic Qualifications: * Bachelor of Science in Biochemistry, or a related pharmaceutical biotechnology discipline * 8+ years in a Quality Control laboratory, specifically within a cGMP biopharmaceutical or pharmaceutical environment for a commercially approved product. * Must have extensive hands-on experience with relevant analytical instrumentation and software (e.g., Empower, SoftMax, LIMS) * Must be detail-oriented and have experience in formal technical writing for Quality Control laboratories (e.g., SOPs, Quality Records, Method Validation/Transfer Protocols, Method Validation/Transfer Reports). * Must have extensive experience in peer-reviewing of Quality Control data. * Experience with the management of stability studies, stability data analysis, and stability data report generation. * Experience in scheduling of Quality Control analytical testing for a team of analysts with throughput time adherence. * Experience with CMO support for external operational management. * Must have experience in Lean Six Sigma methodologies for bottleneck reductions and high throughput efficiencies in a commercial manufacturing environment. Preferred Qualifications: * Master of Science in Biochemistry, or a related pharmaceutical biotechnology discipline * Effective written and verbal communication skills * Lean Six Sigma Black Belt or PMP experience using Lean methodologies for process improvement. * Critical reagent management experience (procurement, preparation, qualification, and management of inventory) is preferred. * Raw Material management experience in sampling, qualification, and management of testing activities. Company Summary: Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: * Competitive Compensation, including base salary and annual performance bonus. * Flexible PTO, holidays, and parental leave. * Generous healthcare benefits, HSA match, 401k match, employer-paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the Americans with Disabilities Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job." Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
    $88k-112k yearly est. Auto-Apply 14h ago
  • Research Chemist (E&L)

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA jobs

    About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. Responsibilities: Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems. Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines. Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems. Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing. Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques. Interpret complex spectral data and fragmentation patterns. Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries. Generate study designs, write protocols, methods, Datasheets and reports. Provide support in the critical review of analytical data, reports and protocols. Write Instrument-related SOPs and provide training on the instrument and related software. Train new recruits in the lab and support the team as needed. Participate in internal meetings and conferences. Provide support during technical transfer between R&D and QC. Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies. Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions. Any other activities as directed by the supervisor. Qualifications: Education/Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: Familiarity with the characterization and isolation of impurities. Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques. Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances. Skilled in laboratory techniques for measuring, weighing, and handling samples. Hands-on experience with HPLC (highly preferred). Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS). Competency in Microsoft Office applications. Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred. Requirements: Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius) Benefits: Pay range $70,000 - $85,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.
    $70k-85k yearly Auto-Apply 45d ago
  • Chemist I - Incoming Quality

    Endo Pharmaceuticals 4.7company rating

    Rochester, NY jobs

    Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing * Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. * Uses laboratory software for analyses 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping * Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals * Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations * With guidance, participates in OOS/OOT/NOE and other investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor * May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training * Maintains assigned training records current and in-compliance * May assist in the training of less senior laboratory staff 5% Compliance * Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting * Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs * Follows internal processes related to controlled substances continuous Safety * Follows EH&S procedures to ensure a safe work environment * Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job * Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. * Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. * Basic knowledge of wet chemistry techniques * Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS * Competency in Microsoft Office Suite Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. * Ability to display and analyze data in a logical manner * Good verbal and written communication skills as well as good computer skills * Attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. * Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals * Must occasionally lift and/or move up to 15-25 lbs. * Ability to wear personal protective equipment, including respirators, gloves, etc. * Specific visions abilities are required by this job include close vision and color vision * Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $49k-66k yearly est. Auto-Apply 42d ago
  • Chemist I - Incoming Quality

    Endo Pharmaceuticals Inc. 4.7company rating

    Rochester, MI jobs

    Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations With guidance, participates in OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training Maintains assigned training records current and in-compliance May assist in the training of less senior laboratory staff 5% Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substances continuous Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS Competency in Microsoft Office Suite Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to display and analyze data in a logical manner Good verbal and written communication skills as well as good computer skills Attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $47k-64k yearly est. Auto-Apply 42d ago
  • Senior Scientist, Quality Control

    Amneal Pharmaceuticals, Inc. 4.6company rating

    Brookhaven, NY jobs

    The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: * Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. * Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. * Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. * Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. * Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. * Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: * Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. * Ensure that expired chemicals and reference standards are removed from laboratory area. * Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. * Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.
    $79k-113k yearly est. Auto-Apply 60d+ ago
  • Senior Scientist, Quality Control

    Amneal Pharmaceuticals 4.6company rating

    Brookhaven, NY jobs

    The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels. Education: Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline - Preferred Experience: With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products Skills: Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate Must be able to assume a role of a leader in team environment as and when required. - Intermediate Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate Must be willing to work extended hours, including weekends, as and when required. - Intermediate Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.
    $90k-95k yearly Auto-Apply 60d+ ago
  • Scientist 2 - QC (Weekends FRI-SUN or SAT-MON - 3 - 12-hour shifts)

    Cambrex 4.4company rating

    High Point, NC jobs

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Scientist 2 - Quality Control role performs routine analytical testing on raw materials, intermediate, and final products as well as in-process testing; performs data entry; draft deviations, and participates in OOS investigations for their testing. Ensures compliance with applicable Company SOPs and regulatory guidance's. This role will support our pilot plant and other work needed on the weekends. 3 days (12 hour shifts) - 36 hour weekly role with full benefits and shift differential pay on top of full time salary. Responsibilities Perform routine testing of raw materials, intermediate, and final products (may include stability) Provide support to the plant by performing in-process testing and analyzing cleaning samples. Maintain laboratory notebook. Ensure equipment is left in good working order after use. Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals). Draft their deviations. Be an active participant in their laboratory investigations. Qualifications/Skills Analytical Chemistry Knowledge: Some understanding of the principles of Analytical Chemistry or Quality Control Cross Discipline Knowledge: Early practical industry exposure to cross functional technical departments, including organic chemistry GMP/Regulatory Knowledge: With less manager supervision, able to better understand need for SOPs and basic regulatory guidance Instrumentation: Basic understanding of key analytical R&D equipment, can operate independently once instructed Communication: Good oral and written communication skills Problem Solving: May be asked to support peer-led laboratory investigation process with manager support Time Management: Ability to handle key assignments, with supervision Leadership: Shares ideas with peers Technical Documentation and Review: Ability to keep a good laboratory notebook and perform data entry, compliance with GDP External Influence: Ability to work within a matrix team Industry Credibility and Rapport: Willing to learn and grow within the local Cambrex Team Operational Excellence: Strives to engage in group/team improvement projects Change Orientation: Able to understand the importance of Cambrex initiatives Education, Experience & Licensing Requirements M. S. in Chemistry or related field or B. S. degree in Chemistry or related field with 2 years minimum experience, or Technical Degree with 4 years minimum experience, or High School Degree with 6 years minimum experience. Experience with and fundamental understanding of several of the following analytical technologies (* - most important): HPLC* FTIR* Titration Basic wet chemistry* NMR XRPD cKF Working knowledge of other analytical equipment common to the pharmaceutical industry This position works with and handles hazardous materials and wastes at Cambrex. This person has the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. He/She is also responsible for recognizing emergency situations concerning hazardous materials and wastes. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-RD1M. S. in Chemistry or related field or B. S. degree in Chemistry or related field with 2 years minimum experience, or Technical Degree with 4 years minimum experience, or High School Degree with 6 years minimum experience. Experience with and fundamental understanding of several of the following analytical technologies (* - most important): HPLC* FTIR* Titration Basic wet chemistry* NMR XRPD cKF Working knowledge of other analytical equipment common to the pharmaceutical industry Perform routine testing of raw materials, intermediate, and final products (may include stability) Provide support to the plant by performing in-process testing and analyzing cleaning samples. Maintain laboratory notebook. Ensure equipment is left in good working order after use. Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals). Draft their deviations. Be an active participant in their laboratory investigations.
    $50k-70k yearly est. Auto-Apply 8d ago
  • Formulation Technician I

    STAQ Pharma Inc. 3.7company rating

    Denver, CO jobs

    This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required. Hours of Work: Tuesday to Friday, 3 PM to 1:30 AM Safety and Responsibilities SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for filling operations. Responsible for acquiring and maintaining classified area gowning qualification. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Values and Behaviors Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. Required Qualifications and Education High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Preferred Skills Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.
    $38k-46k yearly est. 2d ago
  • Chemistry Laboratory Technician

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Responsibilities * Prepare samples according to project protocol and/or related SOPs; * Maintain compliant laboratory documentation; * Perform data analysis and data checking; * Interpret results obtained for accuracy and acceptability; * Clean and sterilize laboratory equipment; and * Other duties deemed necessary. Qualifications * A minimum of a Bachelor's degree, with previous experience in a research laboratory; * Knowledge of GLP, cGMP, and ICH guidelines; * Strong organizational and communication (written and oral) skills; and * Knowledge of Microsoft Word, Excel, and Powerpoint. Travel: None Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $33k-41k yearly est. Auto-Apply 22d ago
  • Lab Tech 1 - Chemistry

    Zoetis 4.9company rating

    Louisville, KY jobs

    Role Description Lab Tech 1 - Chemistry SHIFT: Monday-Friday 10:00 pm - 6:30 am The Lab Technician 1 is responsible for performing routine laboratory tests to support the diagnosis and treatment of animal health conditions. Key responsibilities include preparing samples, operating laboratory equipment, and maintaining accurate records. This role supports the Global Diagnostics division at Zoetis and will work closely with internal veterinarians or medical team, and other lab personnel to ensure the highest standards of quality and accuracy in our diagnostic services. Job Duties: * Prepare biological specimens for testing in various departments, including but not limited to, hematology, urinalysis, serology, chemistry, endocrinology, parasitology, cytology, and coagulation * Use high-throughput automated analyzers, microscopes, and other diagnostic equipment to test various sample types, including but not limited to, whole blood, serum, urine, and feces * Set up and execute laboratory tests, review results, and release findings in accordance with ZRL Standard Operating Procedures (SOPs) * Perform routine and non-routine maintenance on analyzers, including but not limited to, daily, weekly, monthly, and as needed maintenance * Perform basic analyzer troubleshooting techniques on one major department analyzer * Review and accept daily Quality Control reports and weekly Levey-Jennings charts * Handle and store all biological specimens in accordance with ZRL Standard Operating Procedures (SOP) * Maintain a clean and organized laboratory workspace * Properly handle and dispose of medical and biohazardous waste while adhering to all applicable regulatory guidelines * Consistently and properly fill out laboratory logs, including but not limited to maintenance logs, environmental logs, and cleaning logs * Maintain several types of records, including but not limited to medical records, courier logs and manifests * Prepare biological specimens for shipment to offsite testing facilities, adhering to all standards set forth by regulatory bodies including the Department of Transportation (DOT) * Receive, store, and log all laboratory and office supplies into designated locations * Operate and maintain secondary laboratory equipment, including but not limited to centrifuges, pipettes, heating blocks, and slide stainers * Understand and follow SOPs and training modules set forth by Zoetis Reference Laboratories Education/Experience: * High School Diploma or equivalent required. * Associate or Bachelor's degree preferred. * Requires 1-2 years of experience in a clinical laboratory setting and experience in performing basic laboratory testing or operations * Proficient knowledge in one of the following preferred: Hematology, Chemistry, Urinalysis, Endocrinology, Parasitology, and Cytology Technical Skills Required: * Strong attention to detail * Proficiency in using laboratory equipment and software. * IT and LIS (laboratory information systems) experience and general comfort level with computer systems, technology, and equipment interfaces. * Team-oriented with excellent collaboration skills * Ability to work independently and as part of a team * Robust organizational and time management abilities * Excellent data entry skills * Strong written and oral communication skills * Ability to complete tasks with minimal supervision * Fluency in English language Physical Position Requirements: * Ability to lift up to 50 pounds * Ability to bend, kneel, stoop, crouch * Ability to walk, sit, or stand for extended periods Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $64k-81k yearly est. Auto-Apply 30d ago
  • Lab Tech 1 - Chemistry

    Zoetis 4.9company rating

    Louisville, KY jobs

    Role Description Lab Tech 1 - Chemistry SHIFT: Monday-Friday 10:00 pm - 6:30 am The Lab Technician 1 is responsible for performing routine laboratory tests to support the diagnosis and treatment of animal health conditions. Key responsibilities include preparing samples, operating laboratory equipment, and maintaining accurate records. This role supports the Global Diagnostics division at Zoetis and will work closely with internal veterinarians or medical team, and other lab personnel to ensure the highest standards of quality and accuracy in our diagnostic services. Job Duties: · Prepare biological specimens for testing in various departments, including but not limited to, hematology, urinalysis, serology, chemistry, endocrinology, parasitology, cytology, and coagulation · Use high-throughput automated analyzers, microscopes, and other diagnostic equipment to test various sample types, including but not limited to, whole blood, serum, urine, and feces · Set up and execute laboratory tests, review results, and release findings in accordance with ZRL Standard Operating Procedures (SOPs) · Perform routine and non-routine maintenance on analyzers, including but not limited to, daily, weekly, monthly, and as needed maintenance · Perform basic analyzer troubleshooting techniques on one major department analyzer · Review and accept daily Quality Control reports and weekly Levey-Jennings charts · Handle and store all biological specimens in accordance with ZRL Standard Operating Procedures (SOP) · Maintain a clean and organized laboratory workspace · Properly handle and dispose of medical and biohazardous waste while adhering to all applicable regulatory guidelines · Consistently and properly fill out laboratory logs, including but not limited to maintenance logs, environmental logs, and cleaning logs · Maintain several types of records, including but not limited to medical records, courier logs and manifests · Prepare biological specimens for shipment to offsite testing facilities, adhering to all standards set forth by regulatory bodies including the Department of Transportation (DOT) · Receive, store, and log all laboratory and office supplies into designated locations · Operate and maintain secondary laboratory equipment, including but not limited to centrifuges, pipettes, heating blocks, and slide stainers · Understand and follow SOPs and training modules set forth by Zoetis Reference Laboratories Education/Experience: · High School Diploma or equivalent required. · Associate or Bachelor's degree preferred. · Requires 1-2 years of experience in a clinical laboratory setting and experience in performing basic laboratory testing or operations · Proficient knowledge in one of the following preferred: Hematology, Chemistry, Urinalysis, Endocrinology, Parasitology, and Cytology Technical Skills Required: · Strong attention to detail · Proficiency in using laboratory equipment and software. · IT and LIS (laboratory information systems) experience and general comfort level with computer systems, technology, and equipment interfaces. · Team-oriented with excellent collaboration skills · Ability to work independently and as part of a team · Robust organizational and time management abilities · Excellent data entry skills · Strong written and oral communication skills · Ability to complete tasks with minimal supervision · Fluency in English language Physical Position Requirements: · Ability to lift up to 50 pounds · Ability to bend, kneel, stoop, crouch · Ability to walk, sit, or stand for extended periods Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $64k-81k yearly est. Auto-Apply 31d ago
  • Per Diem Chemistry Laboratory Technician

    St. Barnabas Church 3.9company rating

    New York, NY jobs

    Medical Laboratory Technician to work in the Chemistry/Core Laboratory under the direct supervision of supervisor. Will be responsible for performing a variety of complex and routine test within the Core Laboratory complying with all safety and regulatory requirement. Rotate weekends and scheduled holidays base on the needs of the department; participate in interdepartmental collaboration within the institution, to provide the highest quality patient care.
    $30k-37k yearly est. 8h ago
  • QC Medical Packaging Scientist

    Eurofins Us Network 4.4company rating

    Quality control analyst job at Eurofins

    Indianapolis, IN, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. **Job Description** + Perform evaluations and laboratory testing on primary container-closure components and system, critical secondary packaging, and shipping systems utilizing mechanical testing equipment, dimension measurement instruments, and container closure integrity testing systems + Execute methods, collect data, and document results in lab notebooks and LIMS + Participate in the development of laboratory test methods or equipment to ensure reliability and accuracy of results + Interact with colleagues in other groups on a routine basis + Ensure all activities follow established safety standards, regulatory requirements and Good Manufacturing Procedures (GMP **Qualifications** + Bachelor's in science, engineering, or technology, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major) + Bachelor's with two to four years or Masters up to two years of experience + Authorization to work in the United States indefinitely without restriction or sponsorship **Additional Information** + The position is full-time, Monday through Friday, 8 a.m. to 5 p.m., + May be requested to work on weekends, overtime, and holidays based on business needs. + Candidates currently living within a commutable distance of **Indianapolis, IN** are encouraged to apply. + Ability to work overtime as required. + Tasks require repetitive motion and standing for long periods of time. + May be required to respond to off-shift operational issues. + Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options + Life and disability insurance + 401(k) with company match + Paid vacation and holidays + **\#LI-EB1** + Authorization to work in the United States indefinitely without restriction or sponsorship **Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
    $51k-84k yearly est. 1d ago
  • Quality Control Scientist III

    Zoetis 4.9company rating

    Homestead, IA jobs

    This Quality Control Scientist III serves as a vital influencer within the Biologics Quality Control team, shaping the team's approach to quality, compliance, and animal care through expertise and example. In this role, the colleague performs essential product release testing and maintains the highest standards in laboratory animal care, consistently demonstrating best practices and attention to detail. Daily contributions from the colleague help elevate the team's proficiency by sharing knowledge, offering guidance on routine challenges, and providing training to peers. By assisting the team leader with testing coordination and animal distribution, the colleague helps streamline operations and fosters a collaborative, solutions-focused atmosphere. Position Responsibilities: * Conduct potency, identity, inactivation, and extraneous agent testing on antigen stocks and final product vaccines using both egg-based and tissue culture methodologies, adhering to strict aseptic techniques, and operating independently without supervision. * Perform essential product release safety and potency testing in accordance with regulatory and company standards. * Maintain the highest standards of laboratory animal care, consistently demonstrating best practices and ethical responsibility in accordance with IACUC, AAALAC, and other regulatory guidelines. * Accurately record laboratory observations and test results, recognizing and reporting deviations promptly. * Offer support and guidance on laboratory challenges, helping troubleshoot, and resolve routing issues. * Monitor and maintain optimal inventory levels of laboratory supplies and equipment to ensure uninterrupted workflow and compliance with operational standards. * Support the upkeep, cleanliness, and routine maintenance of laboratory facilities to promote a safe, organized, and regulatory-compliant working environment. * Assist the team leader with coordinating testing schedules and animal distribution to optimize workflow. * Foster a collaborative, solutions-focused atmosphere and encourage continuous improvement and ethical standards within the department. * Assist with writing and reviewing Animal Usage Protocols (AUPs) to ensure compliance with IACUC guidelines. * Contribute to the onboarding and performance training of new team members by providing technical guidance, sharing best practices, and supporting skill development to ensure effective integration into laboratory operations. * Help revise departmental methods and protocols, including animal usage procedures and change controls. * Participate in laboratory investigations when necessary. Education and Experience: BS/BA plus 2 years' experience OR AA plus 5-7 years' experience. * Animal care and handling experience * Experienced with the following software programs: Word, Excel, and PowerPoint * Strong technical writing skills * Knowledge of USDA, EU, and Animal Welfare Act guidelines * Experience with maintenance, ordering, testing, and other company-based programs * Willingness to positively embrace change and flexibility in adjusting to changing priorities * Strong attention to detail, ability to work well independently and as a part of a team, and to work effectively with people at all levels within the organization * Trouble-shooting skills Technical Requirements: * Proficient in Microsoft Word, Excel, and PowerPoint, with the ability to leverage advanced features for data analysis, reporting, and presentation development. * Strong attention to detail, ability to work well independently and as a part of a team, and to work effectively with people at all levels within the organization. * Proactively seeks out opportunities for improvements and takes action with minimal direction. * Applies problem solving skills in a team environment. * High level of understanding of multiple technologies and/or assays within the workgroup. * Proficiency of 90% of the testing within the workgroup. Physical Requirements: * Must be able to walk, sit, or stand for long periods of time. * Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently. * Must be able to work scheduled 40 hours with the ability to work overtime as needed. * Must be able to work weekends as needed. * Frequent lifting and carrying of 5 to 25 lbs. * Regular reaching, bending, stooping, and twisting. * Repetitive motion and substantial movement of the wrists, hands, and/or fingers. * Ability to grasp and manipulate objects like pipettors, flasks, and bottles. * Flexibility to cover rotating weekend duties. Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $60k-81k yearly est. Auto-Apply 16d ago
  • Quality Control Data Review Scientist - Nights

    Cambrex 4.4company rating

    Homestead, IA jobs

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure that they are compliant with SOPs, and compendial and CGMP requirements. This individual must have knowledge of instrument theory in order to thoroughly vet and review data and draw conclusions based on collected data. Responsibilities Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/Skills Strong chemistry knowledge with proven ability to handle various project loads is beneficial. Education, Experience & Licensing Requirements Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
    $49k-72k yearly est. Auto-Apply 8d ago

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