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Laboratory Technician jobs at Takeda Pharmaceuticals U.S.A., Inc.

- 564 jobs
  • Medical Lab Tech- Nights

    Exceptional Healthcare 4.0company rating

    Ardmore, OK jobs

    Medical Laboratory Technician (MLT) - Full-Time Night Shift Join our laboratory team at Exceptional Community Hospital. We're seeking a skilled MLT to perform diagnostic testing and deliver exceptional patient care at our state-of-the-art facility. Why Work With Us? We're a patient-focused healthcare provider committed to the highest standards of care in a family-like atmosphere. Our team lives the Exceptional Promise by treating every patient and employee with courtesy, dignity, and respect. Here you'll find growth opportunities, a supportive team, and the resources you need to succeed. Key Qualifications: Bachelor's degree in appropriate sciences Current MLT/MLS license ASCP certification preferred Moderate complexity lab experience Strong computer and QC skills What You'll Do: Provide accurate diagnostic testing for medical staff Perform quality control and equipment maintenance per protocols Document and maintain accurate records on equipment and specimens Maintain a clean, safe lab environment Comply with CLIA, COLA, HIPAA, OSHA regulations Participate in team environment with flexibility for staffing needs Schedule: Full-time, 12-hour night shifts Weekend and holiday availability Perks and Benefits: Comprehensive health, dental, and vision insurance 401(k) with matching contributions Life insurance and paid time off Shift differential Supportive, growth-oriented work environment Why Choose Us? At Exceptional Community Hospitals, we value your expertise and create an environment where your contributions are celebrated. Access cutting-edge technology, a collaborative team, and make a meaningful impact on patient care every day. Take the Next Step in Your Career! Ready to make a difference? Apply today and become part of our exceptional team!
    $49k-67k yearly est. 4d ago
  • Fast Paced Medical Tech - Paid Training

    Biolife Plasma Services 4.0company rating

    Billings, MT jobs

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. Enjoy generous PTO accrual and paid training from day one, great perks beyond just medical benefits! About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MT - Billings U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MT - BillingsWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $16 hourly Auto-Apply 1d ago
  • Phlebotomist - MLT License Preferred

    Biolife Plasma Services 4.0company rating

    Bismarck, ND jobs

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Full Time/Part Time Role Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - ND - Bismarck U.S. Starting Hourly Wage: $17.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - ND - BismarckWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No
    $17 hourly Auto-Apply 23h ago
  • Part-Time Bilingual Spanish/English Phlebotomy Technician - Evening Shifts, No Experience Required, Training Provided

    Biolife Plasma Services 4.0company rating

    Riverton, UT jobs

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - UT - Riverton U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - UT - RivertonWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $16 hourly Auto-Apply 23h ago
  • Raw Materials Chemist I

    Lannett Company, Inc. 4.8company rating

    Seymour, IN jobs

    This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release and stability samples for commercial drug products. Responsibilities: Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements. Testing performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations. Document all laboratory testing and maintain accurate and legible notebooks and records. Peer review of data, reports and notebooks. Other projects and duties as assigned. Experience/Education Requirements: BS Degree in Chemistry or related field AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment BS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment Knowledge of cGMP, USP/NF, and FDA guidelines and regulations Experience in analytical methods and lab instrumentation (e.g. pH, ovens, titrations) Excellent oral and written communication skills Strong organization and time management skills Demonstrated ability to work as part of a cross-functional team Working knowledge of Microsoft Word and Excel Experience with software associated with a Laboratory Information Management System (LIMS) Work mainly performed in lab Stand for extended periods of time in a laboratory setting Wear Personal Protective Equipment (PPE) as needed Work with hazardous chemicals as needed to complete laboratory testing
    $54k-72k yearly est. 3d 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. **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. 4d ago
  • Scientist, Lab Tech Services - Microbiology

    Endo Pharmaceuticals 4.7company rating

    Rochester, NY jobs

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. * Support microbial testing for commercial and pre-commercial products * Support method development, validation, and transfer activities * Perform complex microbial analyses using lab equipment * Investigate complex product issues and support product development * Manage method lifecycle activities * Write and review SOPs, test methods, and validation documents * Serve as a subject matter expert (SME) in microbial testing * Mentor Scientists and Microbiologists Key Responsibilities * Perform routine microbiological testing on raw materials, in-process samples, and finished products * Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests * Analyze environmental monitoring samples from cleanrooms and production areas * Support Validation of microbial methods for product and raw material testing * Prepare protocols, reports, and test methods * Conduct testing to support development and stability studies * Present and review data with project teams * Review lab documentation and supplier technical documents * Use lab software and detect abnormalities during testing * Provide general lab support and maintain equipment * Troubleshoot instruments and perform follow-up analyses * Report and investigate out-of-specification results * Write and review SOPs and investigation reports that support root cause analysis * Recommend corrective and preventive actions (CAPA) * Support training of microbiologists and improve training process records * Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) * Ensure compliance with FDA and other regulatory standards * Follow safety procedures and handle hazardous materials properly * Uses laboratory software for analyses * Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping * Troubleshoots instrumentation and performs subsequent analyses 20% Investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action * Participates in root cause identification of complex laboratory investigations * Writes, edits, and reviews SOPs and laboratory investigations 10% Training * Trains microbiologists * Continuously updates knowledge with respect to the latest technologies related to Microbiology * Maintains assigned training records current and in-compliance * Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance * Identifies need for SOPs and writes or revises, as appropriate * Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations * Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs * Takes active role in auditing laboratory logbooks/documentation to ensure compliance * 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 Microbiology or related field with 6 years' relevant microbiological laboratory experience OR * Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR * PhD in above disciplines with some relevant 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. * Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. * Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. * Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS * Has demonstrated competence in conducting microbial testing * Strong knowledge of aseptic technique and contamination control * 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 critically review and analyze data, interpret information, and draw conclusions from relevant or missing information * Ability to display and analyze data in a logical manner * Strong verbal and written communication skills as well as good computer skills * Strong attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities * 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 firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
    $35k-45k yearly est. Auto-Apply 41d ago
  • Molecular Technologist I - MALDI 1

    Charles River Laboratories 4.3company rating

    Delaware jobs

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Charles River Labs is seeking a Molecular Technologist for our Microbial Solutions site located Newark, DE. This position will support our MALDI Lab function with working hours Monday - Friday M-F 10AM-6:30PM . The Molecular Technologist I will process customer samples in the microbiology laboratory utilizing the various technology platforms including but not limited to bacterial 16S rDNA and fungal ITS2 sequencing, MALDI-TOF mass spectrometry and ribotyping. Ensure adherence to regulatory requirements and GMP compliance. Roles and Responsibilities • Conduct accurate processing of customer samples in accordance with current SOPs. • Receive, unpack, log, and subculture customer samples according to current SOPs. • Aliquot and prepare reagents. • Perform test streaks for isolation, PCR, sequencing of customer samples and other laboratory processes including but not limited to mass spectrometry and ribotyping. • Perform continual maintenance, repair and cleaning of all laboratory equipment. • Perform pipette verification. • Operate and maintain laser cutter. • Provide backup for all laboratory functions when needed. • Dispose of microbe cultures, chemicals and glass in proper waste containers. • Collaborate with technical support to resolve discrepancies with customer samples. • Comply with all aspects of laboratory safety, safety stations, safety manuals, safety SOP, and MSDS sheets. • Suggest process improvements. • Perform or support special projects in the lab when needed. • Perform all other related duties as assigned. Job Qualifications Education: Associates Degree in Microbiology or related discipline required. Bachelors Degree preferred. Experience: 0-2 years related experience in a laboratory setting or academic setting. Must have ability to work in a fast paced and team-oriented work environment. Strong attention to detail and accuracy required. Compensation Data The compensation range for this position is $21- $22 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Competencies Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement. About Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit ***************
    $21-22 hourly Easy Apply 12d ago
  • Molecular Technologist I - MALDI 1

    Charles River Laboratories 4.3company rating

    Newark, DE jobs

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Charles River Labs is seeking a Molecular Technologist for our Microbial Solutions site located Newark, DE. This position will support our MALDI Lab function with working hours Monday - Friday M-F 10AM-6:30PM . The Molecular Technologist I will process customer samples in the microbiology laboratory utilizing the various technology platforms including but not limited to bacterial 16S rDNA and fungal ITS2 sequencing, MALDI-TOF mass spectrometry and ribotyping. Ensure adherence to regulatory requirements and GMP compliance. Roles and Responsibilities * Conduct accurate processing of customer samples in accordance with current SOPs. * Receive, unpack, log, and subculture customer samples according to current SOPs. * Aliquot and prepare reagents. * Perform test streaks for isolation, PCR, sequencing of customer samples and other laboratory processes including but not limited to mass spectrometry and ribotyping. * Perform continual maintenance, repair and cleaning of all laboratory equipment. * Perform pipette verification. * Operate and maintain laser cutter. * Provide backup for all laboratory functions when needed. * Dispose of microbe cultures, chemicals and glass in proper waste containers. * Collaborate with technical support to resolve discrepancies with customer samples. * Comply with all aspects of laboratory safety, safety stations, safety manuals, safety SOP, and MSDS sheets. * Suggest process improvements. * Perform or support special projects in the lab when needed. * Perform all other related duties as assigned. Job Qualifications * Education: Associates Degree in Microbiology or related discipline required. Bachelors Degree preferred. * Experience: 0-2 years related experience in a laboratory setting or academic setting. * Must have ability to work in a fast paced and team-oriented work environment. Strong attention to detail and accuracy required. Compensation Data The compensation range for this position is $21- $22 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Competencies Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others. Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing. Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness. Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement. About Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231304
    $21-22 hourly Easy Apply 14d ago
  • Laboratory Assistant Manager

    Affinity Health Partners 4.7company rating

    Plymouth, NC jobs

    The Laboratory Assistant Manager is responsible for the day-to-day operations of the laboratory, including staff supervision, assisting with budgeting, and placing orders for lab supplies. They develop and implement policies and procedures to ensure the safety of laboratory personnel and the quality of lab results. The Laboratory Assistant Manager also coordinates with other departments within the hospital or clinic to ensure smooth operation of the laboratory. ESSENTIAL JOB DUTIES: To oversee and manage all aspects of the laboratory, including personnel, equipment, and operations. To develop and implement policies and procedures to ensure the efficient and effective operation of the laboratory. To ensure that all laboratory personnel are properly trained and qualified to perform their duties. To maintain a safe and clean working environment in the laboratory. To monitor and control inventory levels of supplies and materials needed for the operation of the laboratory. To prepare reports on the activities of the laboratory as required by management or regulatory agencies. RESPONSIBILITIES/KNOWLEDGE/SKILLS: Supervise and coordinate the work of laboratory technicians and other staff. Plan and oversee the laboratory's budget, including purchases of equipment and supplies. Develop and implement policies and procedures for the operation of the laboratory. Ensure that the laboratory meets all applicable safety regulations. Keep abreast of new developments in the field of laboratory science and incorporate them into the lab's operations as appropriate. Train new employees in the use of lab equipment and procedures. Perform various tests and analyses using lab equipment, as needed. Prepare reports on the results of tests and analyses conducted in the laboratory Requirements QUALIFICATIONS: High School Diploma Training in formally accredited Laboratory Science Program Previous job experiences as a MLT/MLS Must be eligible for certification PHYSICAL REQUIREMENTS: Frequent mobility and/or sitting required for extended periods of time Manual dexterity and use of a calculator or computer keyboard. Varied activities including standing, walking, reaching, bending, lifting Occasionally lifts to 25 pounds Requires corrected vision and hearing to normal ranges Requires working under stressful conditions or working irregular hours Exposure to communicable diseases, toxic substances, ionization radiation, medicinal preparations, and other conditions common to a hospital and/or clinic environment
    $43k-75k yearly est. 60d+ ago
  • Laboratory Assistant Manager

    Affinity Health Partners LLC 4.7company rating

    Plymouth, NC jobs

    Job DescriptionDescription: The Laboratory Assistant Manager is responsible for the day-to-day operations of the laboratory, including staff supervision, assisting with budgeting, and placing orders for lab supplies. They develop and implement policies and procedures to ensure the safety of laboratory personnel and the quality of lab results. The Laboratory Assistant Manager also coordinates with other departments within the hospital or clinic to ensure smooth operation of the laboratory. ESSENTIAL JOB DUTIES: To oversee and manage all aspects of the laboratory, including personnel, equipment, and operations. To develop and implement policies and procedures to ensure the efficient and effective operation of the laboratory. To ensure that all laboratory personnel are properly trained and qualified to perform their duties. To maintain a safe and clean working environment in the laboratory. To monitor and control inventory levels of supplies and materials needed for the operation of the laboratory. To prepare reports on the activities of the laboratory as required by management or regulatory agencies. RESPONSIBILITIES/KNOWLEDGE/SKILLS: Supervise and coordinate the work of laboratory technicians and other staff. Plan and oversee the laboratory's budget, including purchases of equipment and supplies. Develop and implement policies and procedures for the operation of the laboratory. Ensure that the laboratory meets all applicable safety regulations. Keep abreast of new developments in the field of laboratory science and incorporate them into the lab's operations as appropriate. Train new employees in the use of lab equipment and procedures. Perform various tests and analyses using lab equipment, as needed. Prepare reports on the results of tests and analyses conducted in the laboratory Requirements: QUALIFICATIONS: High School Diploma Training in formally accredited Laboratory Science Program Previous job experiences as a MLT/MLS Must be eligible for certification PHYSICAL REQUIREMENTS: Frequent mobility and/or sitting required for extended periods of time Manual dexterity and use of a calculator or computer keyboard. Varied activities including standing, walking, reaching, bending, lifting Occasionally lifts to 25 pounds Requires corrected vision and hearing to normal ranges Requires working under stressful conditions or working irregular hours Exposure to communicable diseases, toxic substances, ionization radiation, medicinal preparations, and other conditions common to a hospital and/or clinic environment
    $43k-75k yearly est. 7d ago
  • Scientist, Lab Tech Services - Microbiology

    Endo International 4.7company rating

    Rochester, MI jobs

    **Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. **Job Description** The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. + Support microbial testing for commercial and pre-commercial products + Support method development, validation, and transfer activities + Perform complex microbial analyses using lab equipment + Investigate complex product issues and support product development + Manage method lifecycle activities + Write and review SOPs, test methods, and validation documents + Serve as a subject matter expert (SME) in microbial testing + Mentor Scientists and Microbiologists **Key Responsibilities** + Perform routine microbiological testing on raw materials, in-process samples, and finished products + Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests + Analyze environmental monitoring samples from cleanrooms and production areas + Support Validation of microbial methods for product and raw material testing + Prepare protocols, reports, and test methods + Conduct testing to support development and stability studies + Present and review data with project teams + Review lab documentation and supplier technical documents + Use lab software and detect abnormalities during testing + Provide general lab support and maintain equipment + Troubleshoot instruments and perform follow-up analyses + Report and investigate out-of-specification results + Write and review SOPs and investigation reports that support root cause analysis + Recommend corrective and preventive actions (CAPA) + Support training of microbiologists and improve training process records + Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) + Ensure compliance with FDA and other regulatory standards + Follow safety procedures and handle hazardous materials properly + Uses laboratory software for analyses + Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment + Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping + Troubleshoots instrumentation and performs subsequent analyses 20% Investigations + Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action + Participates in root cause identification of complex laboratory investigations + Writes, edits, and reviews SOPs and laboratory investigations 10% Training + Trains microbiologists + Continuously updates knowledge with respect to the latest technologies related to Microbiology + Maintains assigned training records current and in-compliance + Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance + Identifies need for SOPs and writes or revises, as appropriate + Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations + Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs + Takes active role in auditing laboratory logbooks/documentation to ensure compliance + 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 Microbiology or related field with 6 years' relevant microbiological laboratory experience OR + Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR + PhD in above disciplines with some relevant 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._ + Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. + Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. + Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS + Has demonstrated competence in conducting microbial testing + Strong knowledge of aseptic technique and contamination control + 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 critically review and analyze data, interpret information, and draw conclusions from relevant or missing information + Ability to display and analyze data in a logical manner + Strong verbal and written communication skills as well as good computer skills + Strong attention to details and accurate record keeping + Establish and maintain cooperative working relationships with others + Solid organizational skills + Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities + 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 firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $30k-38k yearly est. 60d+ ago
  • Scientist, Lab Tech Services - Microbiology

    Endo Pharmaceuticals Inc. 4.7company rating

    Rochester, MI jobs

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. Support microbial testing for commercial and pre-commercial products Support method development, validation, and transfer activities Perform complex microbial analyses using lab equipment Investigate complex product issues and support product development Manage method lifecycle activities Write and review SOPs, test methods, and validation documents Serve as a subject matter expert (SME) in microbial testing Mentor Scientists and Microbiologists Key Responsibilities Perform routine microbiological testing on raw materials, in-process samples, and finished products Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests Analyze environmental monitoring samples from cleanrooms and production areas Support Validation of microbial methods for product and raw material testing Prepare protocols, reports, and test methods Conduct testing to support development and stability studies Present and review data with project teams Review lab documentation and supplier technical documents Use lab software and detect abnormalities during testing Provide general lab support and maintain equipment Troubleshoot instruments and perform follow-up analyses Report and investigate out-of-specification results Write and review SOPs and investigation reports that support root cause analysis Recommend corrective and preventive actions (CAPA) Support training of microbiologists and improve training process records Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Ensure compliance with FDA and other regulatory standards Follow safety procedures and handle hazardous materials properly Uses laboratory software for analyses Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping Troubleshoots instrumentation and performs subsequent analyses 20% Investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Participates in root cause identification of complex laboratory investigations Writes, edits, and reviews SOPs and laboratory investigations 10% Training Trains microbiologists Continuously updates knowledge with respect to the latest technologies related to Microbiology Maintains assigned training records current and in-compliance Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance Identifies need for SOPs and writes or revises, as appropriate Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs Takes active role in auditing laboratory logbooks/documentation to ensure compliance 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 Microbiology or related field with 6 years' relevant microbiological laboratory experience OR Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR PhD in above disciplines with some relevant 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. Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting microbial testing Strong knowledge of aseptic technique and contamination control 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 critically review and analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities 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 firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
    $30k-38k yearly est. Auto-Apply 53d ago
  • Formulation Technician III

    PCI Pharma Services 4.1company rating

    Madison, WI 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. The Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques Has ownership for the daily formulation activities to ensure 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 of errors that could lead to product and or finical loss Troubleshoots and resolve problems with equipment or processes in the course of performing job duties Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation Prepares equipment and components for sterilization and Lyophilization Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols. Completes Batch Records accurately and completely prior to submission to supervision for review Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Initiate and support revisions to SOPs and FORMs as needed Participates in investigations, and contribute to identifying corrective and preventative actions Cross trains 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 Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients Work with enabling groups to improve/implement processes Other duties as assigned Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Able to stand for long periods of time, the majority of the work shift Able to lift 30lbs repeatedly Able to wear PPE (mask, gloves, respiratory) Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. TRAVEL - < 10% 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. High School education, AS degree or BS degree in related field of study is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Strong communication skills Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Resilient as well as flexible 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.
    $32k-41k yearly est. Auto-Apply 60d+ ago
  • Laboratory Technician, Intern

    Eurofins USA Biopharma Services 4.4company rating

    San Diego, CA jobs

    Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA. Group's key figures are approx. 6.7 billion Euros, over 940 laboratories across 59 countries, and about 61,000 staff. Job Description Eurofins BPT San Diego is seeking a motivated intern to support our Analytical Science teams by assisting with laboratory tasks and process improvement initiatives. This position is a temporary, part-time, entry-level position involved in day-to-day activities in a laboratory setting under prescribed procedures (protocols, standard operating procedures, methods, etc.). Responsibilities include: Generates data from a variety of laboratory techniques and analytical instrumentation such as but not limited to, pH, analytical balance, sample preparation, etc. Participates in studies as directed. Completes the necessary tasks associated with projects in designated areas. Carries out routine experiments and procedures in accordance with all applicable regulatory requirements as defined by protocol, method, and standard operating procedures. Maintains clean laboratory conditions which include, but is not limited to, cleaning glassware, emptying trash, mopping floors, etc. Adheres to schedule according to Eurofins or contracting organization's timetable and follows daily or weekly routines necessary to ensure on-time delivery. Performs work in accordance with CGMP principals and standard operating procedures. Completes documentation legibly, timely, and accurately according to all regulatory requirements. Maintains and completes equipment log books. Appropriately documents all movement of materials during process of receipt, transfer, disposal, or archiving and distributes those documents as required. Communicates effectively and regularly with supervisor regarding timelines, project completion, and any issues that may arise. Depending on area of assignment, may be required to move/transfer materials from one department to another; check-in/out materials as requested by study personnel; and examine materials received/delivered for safety, accuracy of shipment, and viability of content. May assist in quality check of spreadsheets and other data. Performs other related duties as required and directed The ideal candidate will possess: Knowledge of basic office equipment (computers, printers, faxes, copiers, etc.). Strong attention to detail and organizational skills. Excellent customer service skills. Ability to work independently and communicate effectively in a team environment. Ability to define problems, collect data, establish facts, and draw valid conclusions. Able to apply common sense understanding to carry out detailed written, oral, diagram, or scheduled instructions. Working knowledge of Microsoft Outlook, Word, PowerPoint and Excel is required. Flexible hours can be accommodated; however, regular and reliable attendance is a requirement of this position. Qualifications Must be a minimum of 18 years of age High School diploma or equivalent Currently enrolled in a science or engineering program preferred. Authorization to work in the United States. Learning Opportunities: Hands-on experience within a real-world pharmaceutical laboratory. Exposure to GMP/GLP principles and regulatory compliance. Development of skills in Lean/5S mindset, scientific documentation, and team-based communication. Confidentiality Requirement: The intern must sign a Confidentiality Agreement prior to starting, agreeing not to disclose, share, or misuse any proprietary data, methods, or intellectual property accessed during the internship. All work products remain the property of Eurofins Advantar Laboratories. Additional Information Pay rate of this position is $20/h. Position is temporary, part-time, with flexibility Monday-Friday, ranging from 8 a.m.-4:30 p.m. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
    $20 hourly 12d ago
  • Laboratory Technician, Intern

    Eurofins Scientific 4.4company rating

    San Diego, CA jobs

    Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA. Group's key figures are approx. 6.7 billion Euros, over 940 laboratories across 59 countries, and about 61,000 staff. Job Description Eurofins BPT San Diego is seeking a motivated intern to support our Analytical Science teams by assisting with laboratory tasks and process improvement initiatives. This position is a temporary, part-time, entry-level position involved in day-to-day activities in a laboratory setting under prescribed procedures (protocols, standard operating procedures, methods, etc.). Responsibilities include: * Generates data from a variety of laboratory techniques and analytical instrumentation such as but not limited to, pH, analytical balance, sample preparation, etc. * Participates in studies as directed. Completes the necessary tasks associated with projects in designated areas. * Carries out routine experiments and procedures in accordance with all applicable regulatory requirements as defined by protocol, method, and standard operating procedures. * Maintains clean laboratory conditions which include, but is not limited to, cleaning glassware, emptying trash, mopping floors, etc. * Adheres to schedule according to Eurofins or contracting organization's timetable and follows daily or weekly routines necessary to ensure on-time delivery. * Performs work in accordance with CGMP principals and standard operating procedures. * Completes documentation legibly, timely, and accurately according to all regulatory requirements. Maintains and completes equipment log books. Appropriately documents all movement of materials during process of receipt, transfer, disposal, or archiving and distributes those documents as required. * Communicates effectively and regularly with supervisor regarding timelines, project completion, and any issues that may arise. * Depending on area of assignment, may be required to move/transfer materials from one department to another; check-in/out materials as requested by study personnel; and examine materials received/delivered for safety, accuracy of shipment, and viability of content. * May assist in quality check of spreadsheets and other data. * Performs other related duties as required and directed The ideal candidate will possess: * Knowledge of basic office equipment (computers, printers, faxes, copiers, etc.). * Strong attention to detail and organizational skills. Excellent customer service skills. * Ability to work independently and communicate effectively in a team environment. * Ability to define problems, collect data, establish facts, and draw valid conclusions. Able to apply common sense understanding to carry out detailed written, oral, diagram, or scheduled instructions. * Working knowledge of Microsoft Outlook, Word, PowerPoint and Excel is required. * Flexible hours can be accommodated; however, regular and reliable attendance is a requirement of this position. Qualifications * Must be a minimum of 18 years of age * High School diploma or equivalent * Currently enrolled in a science or engineering program preferred. * Authorization to work in the United States. Learning Opportunities: * Hands-on experience within a real-world pharmaceutical laboratory. * Exposure to GMP/GLP principles and regulatory compliance. * Development of skills in Lean/5S mindset, scientific documentation, and team-based communication. Confidentiality Requirement: The intern must sign a Confidentiality Agreement prior to starting, agreeing not to disclose, share, or misuse any proprietary data, methods, or intellectual property accessed during the internship. All work products remain the property of Eurofins Advantar Laboratories. Additional Information Pay rate of this position is $20/h. Position is temporary, part-time, with flexibility Monday-Friday, ranging from 8 a.m.-4:30 p.m. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
    $20 hourly 13d ago
  • Laboratory Technician, Intern

    Eurofins USA Biopharma Services 4.4company rating

    San Diego, CA jobs

    Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA. Group's key figures are approx. 6.7 billion Euros, over 940 laboratories across 59 countries, and about 61,000 staff. Job Description Eurofins BPT San Diego is seeking a motivated intern to support our Analytical Science teams by assisting with laboratory tasks and process improvement initiatives. This position is a temporary, part-time, entry-level position involved in day-to-day activities in a laboratory setting under prescribed procedures (protocols, standard operating procedures, methods, etc.). Responsibilities include: Generates data from a variety of laboratory techniques and analytical instrumentation such as but not limited to, pH, analytical balance, sample preparation, etc. Participates in studies as directed. Completes the necessary tasks associated with projects in designated areas. Carries out routine experiments and procedures in accordance with all applicable regulatory requirements as defined by protocol, method, and standard operating procedures. Maintains clean laboratory conditions which include, but is not limited to, cleaning glassware, emptying trash, mopping floors, etc. Adheres to schedule according to Eurofins or contracting organization's timetable and follows daily or weekly routines necessary to ensure on-time delivery. Performs work in accordance with CGMP principals and standard operating procedures. Completes documentation legibly, timely, and accurately according to all regulatory requirements. Maintains and completes equipment log books. Appropriately documents all movement of materials during process of receipt, transfer, disposal, or archiving and distributes those documents as required. Communicates effectively and regularly with supervisor regarding timelines, project completion, and any issues that may arise. Depending on area of assignment, may be required to move/transfer materials from one department to another; check-in/out materials as requested by study personnel; and examine materials received/delivered for safety, accuracy of shipment, and viability of content. May assist in quality check of spreadsheets and other data. Performs other related duties as required and directed The ideal candidate will possess: Knowledge of basic office equipment (computers, printers, faxes, copiers, etc.). Strong attention to detail and organizational skills. Excellent customer service skills. Ability to work independently and communicate effectively in a team environment. Ability to define problems, collect data, establish facts, and draw valid conclusions. Able to apply common sense understanding to carry out detailed written, oral, diagram, or scheduled instructions. Working knowledge of Microsoft Outlook, Word, PowerPoint and Excel is required. Flexible hours can be accommodated; however, regular and reliable attendance is a requirement of this position. Qualifications Must be a minimum of 18 years of age High School diploma or equivalent Currently enrolled in a science or engineering program preferred. Authorization to work in the United States. Learning Opportunities: Hands-on experience within a real-world pharmaceutical laboratory. Exposure to GMP/GLP principles and regulatory compliance. Development of skills in Lean/5S mindset, scientific documentation, and team-based communication. Confidentiality Requirement: The intern must sign a Confidentiality Agreement prior to starting, agreeing not to disclose, share, or misuse any proprietary data, methods, or intellectual property accessed during the internship. All work products remain the property of Eurofins Advantar Laboratories. Additional Information Pay rate of this position is $20/h. Position is temporary, part-time, with flexibility Monday-Friday, ranging from 8 a.m.-4:30 p.m. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
    $20 hourly 12d ago
  • Formulation Technician I

    STAQ Pharma Inc. 3.7company rating

    Denver, CO jobs

    Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation 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 weekends, may be required. Schedule: Tuesday to Friday 3 PM Until 1:30 AM (or until work is completed) Pay: $25/hour 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-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. 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. 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. 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. 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.
    $25 hourly 13d ago
  • Formulation Technician I

    STAQ Pharma Inc. 3.7company rating

    Denver, CO jobs

    Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation 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 weekends, may be required. Schedule: Monday to Thursday 5 AM until 3:30 PM (or until work is completed) Pay: $23/hour 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-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. 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. 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. 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. 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.
    $23 hourly 13d ago
  • Senior Laboratory Analyst

    Sanofi Us 4.3company rating

    Pennsylvania jobs

    Job Title: Senior Laboratory Analyst About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Global Clinical Immunology (GCI) organization, part of Late Stage Global Immunology within Vaccines R&D, specializes in developing, validating, and deploying regulated bioanalytical assays to assess immune responses to vaccines throughout their lifecycle. Our mission is to provide specialized immunology expertise and generate robust clinical datasets that inform decision-making for both clinical development and post-licensure activities. Our GCLP-compliant bioanalytical laboratories are based in Swiftwater, PA. Main responsibilites Laboratory testing and support activities as assigned including: Routine and non-routine testing Maintenance of any associated testing documentation Experienced analysts may assist with data review and approval of clinical testing alongside senior personnel Sample/reagent handling Laboratory support activities including, but not limited to: Responsible for and/or performs lab and/or facility housekeeping, waste, and general maintenance Ensures that security and safety procedures and protocols are observed and followed. Monitors, maintains laboratory inventory; responsible for reagent/material orders, receipt and delivery of laboratory reagent/material and equipment. Train other analysts on assay methods and relevant associated procedures (i.e. equipment, data and sample handling, etc.) Regulatory/Quality Management: Ensures adherence to all applicable quality, corporate, safety, and regulatory requirements. Other: As assigned and under the direction of management, independently conducts more complex research activities in support of short- and long-term laboratory operational requirements. Any other related duties required by the research projects or management of the research laboratory or analytical facility. About You Education/experience: Bachelor's degree in Biological Sciences (B.Sc.) plus minimum 2 years of experience, or Master's degree in Biological Sciences (M.Sc.) plus minimum 1 year of relevant experience in the role Ability to operate in a BSL-3 environment while fully gowned Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $26,17 - $34,89 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $26 hourly Auto-Apply 15d ago

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