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Sample Prep Technician jobs at Eurofins

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  • Sample Preparation Technician I

    Eurofins Scientific 4.4company rating

    Sample prep technician job at Eurofins

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Essential Duties and Responsibilities: * Demonstrates and promotes the company vision * Regular attendance and punctuality * Applies GMP/GLP in all areas of responsibility, as appropriate. * Performs any combination of sample preparation tasks to ensure sample homogeneity which includes but is not limited to labeling, transferring, liquid nitrogen use, milling, blending, weighing, disposal of samples, etc. * Communicates sample information effectively. * Communicates discrepancies to appropriate personnel, and assists with problem solving. * Handles internal customer inquiries and requests. * Works with the customer service coordinators to resolve client or sample issues. * Introduces and develops improvement ideas for the group with the assistance of others. * Learns sample preparation procedures involving larger equipment. * Learns how to perform equipment maintenance/basic repairs and place work orders. * Introduction to cross-training between food and dietary supplement prep procedures. * Conducts all activities in a safe and efficient manner * Performs other duties as assigned Qualifications * High School diploma or equivalent. * Working knowledge of computers. * Minimum 2 years' experience in a position with high attention to detail. * Customer service skills including attention to detail, accuracy, confidentiality and effective communication skills. * Ability to identify and communicate customer service needs. * Conflict resolution skills. * Good documentation skills. * Mandatory immunizations and screening as required. * Will be exposed to potential food allergens (ex. Milk, tree nuts, peanuts, fish, shellfish, etc.). * Overtime and weekend work as required. * Physical requirements include, but not are limited to, standing, bending, reaching and lifting. May work in walk-in cold storage units. * Expected to understand the process for handling hazardous wastes and receive on-the-job training for handling specific waste types in their job area. * Must be able to lift up to 50 lbs. for short periods of time. * Work requires use of PPE (personal protective equipment). Additional Information What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Food Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $33k-42k yearly est. 10d ago
  • TECH - ECHO

    Sierra Medical Center 3.9company rating

    Reno, NV jobs

    Responsibilities Sierra Medical Center is part of Northern Nevada Health System, a regional multi-facility system that has excelled at offering quality care to residents of the greater Truckee Meadows. Sierra Medical Center is a 170-bed acute care hospital offering services including 24/7 ER care, cardiology, oncology, labor and delivery, level II NICU, surgical and orthopedic services, and much more. Learn more at northernnevadahealth.com What we at Sierra Medical Center value: • Compassion: We treat everyone with kindness and warmth because we genuinely care about every patient, employee and physician like they are family. • Empathy: We put ourselves in our patient's shoes and deliver clinical care with a personalized touch. • Teamwork: We foster a caring and friendly work environment to bring the best possible outcomes in our patient's lives. • Quality: We strive to provide excellence in clinical care. • Ethics: We conduct our business with the highest ethical and moral standards. • Respect: We promise to honor the dignity, individuality and rights of everyone. • Service Excellence: We provide personalized and professional service that exceeds the expectations of those we serve. • Innovation: We continually invest in technology and process improvements to develop new and better ways of delivering clinical care Learn more at northernnevadahealth.com Job summary:Uses ultrasound to visualize internal cardiac structures, obtain measurements of cardiac valves, ventricle and left atrium and visualize blood flow. Assists the physician with complex ultrasound procedures. Job Duties/Responsibilities: Ability to perform electrocardiograms per procedure. Ability to expand scope of examination according to any abnormalities observed. Maintains records of all procedures performed, sends reports to requesting physicians and archives the tape and text of patient examinations. Manages and operates equipment safely and correctly. Inspects ultrasound equipment daily to ensure it is operating effectively. Reports any malfunctions Benefits for full and part time employees: Challenging and rewarding work environment Competitive Compensation & Generous Paid Time Off Excellent Medical, Dental, Vision and Prescription Drug Plans 401(K) with company match and discounted stock plan Tuition Reimbursement/Repayment Program Career development opportunities within UHS and its 300+ Subsidiaries! More information is available on our Benefits Guest Website: benefits.uhsguest.com If you would like to learn more about the position before applying, please contact Michelle Lopez-Reyes, Recruiter @ ******************************. About Universal Health Services: One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. During the year, UHS was again recognized as one of the World's Most Admired Companies by Fortune; and listed in Forbes ranking of America's Largest Public Companies. Operating acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located all over the U.S. States, Washington, D.C., Puerto Rico and the United Kingdom. *********** Qualifications Bachelor of Science degree preferred. ARDMS or CCI certificate preferred. Prefer specific experience and training in Ultrasound. Registered with the American Registry of Diagnostic Medical Sonographers, or eligible. Current BLS Certification EEO Statement All UHS subsidiaries are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates. UHS subsidiaries are equal opportunity employers and as such, openly support and fully commit to recruitment, selection, placement, promotion and compensation of individuals without regard to race, color, religion, age, sex (including pregnancy, gender identity, and sexual orientation), genetic information, national origin, disability status, protected veteran status or any other characteristic protected by federal, state or local laws. We believe that diversity and inclusion among our teammates is critical to our success. Avoid and Report Recruitment Scams At UHS and all our subsidiaries, our Human Resources departments and recruiters are here to help prospective candidates by matching skill set and experience with the best possible career path at UHS and our subsidiaries. During the recruitment process, no recruiter or employee will request financial or personal information (e.g., Social Security Number, credit card or bank information, etc.) from you via email. Our recruiters will not email you from a public webmail client like Hotmail, Gmail, Yahoo Mail, etc. If you suspect a fraudulent job posting or job-related email mentioning UHS or its subsidiaries, we encourage you to report such concerns to appropriate law enforcement. We encourage you to refer to legitimate UHS and UHS subsidiary career websites to verify job opportunities and not rely on unsolicited calls from recruiters.
    $28k-42k yearly est. 3d ago
  • Laboratory Technician

    Kelly 4.1company rating

    Midland, MI jobs

    Kelly is currently seeking an Analytics & Data Science Laboratory Technician for a long-term opportunity in Midland, Michigan! The Laboratory Technician supports customer fluid analysis by conducting laboratory analyses, as needed, which provide critical data. The Lab Tech also prepares samples, performs preventive maintenance of laboratory instrumentation and uses data systems to acquire data, and reports results to the client. This role requires established basic laboratory skills to perform a range of routine lab activities using existing standard operating procedures and or analytical scientific methods. Do you have what it takes?! Primary Responsibilities:Develop a thorough understanding of the operations of laboratory equipment and methods. This includes refractive index, gas chromatography, liquid chromatography, ion chromatography, inductively coupled plasma atomic emission spectroscopy, titration for pH and reserve alkalinity. Responsible for managing, then safely executing laboratory work requests, maintaining and running relevant laboratory apparatus and testing equipment and documenting data. Understands the value of high quality data and utilizes good laboratory techniques and practices to generate such data. Accurately and reliably records readings and observations using relevant equipment and instruments. Organizes and prepares data tables and charts to present data collected in studies supported. Independently interprets data and promptly communicates unexpected results to the team. Responsible for calibration/standardization, safe operation, and routine maintenance of simple and complex instruments, and systems. Troubleshoots faulty equipment effects repairs or initiates repair processes as appropriate. Evaluates and revises procedures to improve efficiency, effectiveness, or safety. Makes proposals and recommendations for equipment/systems modifications. Promptly and effectively communicates issues to lab owner in order to enable or accelerate problem resolution. Actively participate in work group team meetings to address safety, process improvement, problem solving, and other work group, department, and functional topics. Takes personal responsibility for Environment, Health and Safety (EH&S) compliance within the team or work group. Maintain inventories of consumable materials, chemicals, and supplies related to activities. Required Qualifications:Proficiency in Microsoft applications, such as Word and Excel, and have the ability to learn new systems quickly. Proficiency in basic chemicals laboratory operation and basic Environmental Health and Safety (EH&S) requirements such as safe operating procedures and management of change is preferred. Strong understanding and commitment to their own and the safety of others. Must have strong multi-tasking, problem solving and time management skills. Be an effective collaborator and contributing member of the local work team. Must be willing and able to work in such environments wearing safety equipment, such as goggles, Lab coats, dust masks and steel-toed shoes. Must be willing and able to stand or walk for extended periods of time. Experience Preferred:Completion of Vocational Education or Upper Secondary Education (i.e. High School Diploma) plus laboratory, manufacturing or other related experience. Post Upper Secondary Education coursework in chemistry or related coursework.
    $34k-52k yearly est. 2d ago
  • Laboratory Technician

    Kelly 4.1company rating

    Plaquemine, LA jobs

    We are looking for a dedicated and passionate individual to join our team as a Laboratory Technician in our METHOCELTM Quality Control lab in Plaquemine, LA. In this role you will be responsible for performing routine analyses, evaluating results, and calibrating and maintaining analytical systems to provide analytical data to produce and release products including Pharmaceutical Excipients and Industrial Specialty products. The ideal candidate will have: · Relevant laboratory experience. (Experience with biology, bioscience, biotechnology, biochemistry, chemistry, or aseptic techniques is a plus.) · Can demonstrate mechanical aptitude and problem-solving skills. · Strong written and verbal communication skills plus ability to work and collaborate with a team. · Basic computer skills. (Experience with computer-based systems such as LIMS, Electronic Logbook, etc. is a plus.) Strong sense of self-motivation and ability to work under minimal supervision. · Ability to prioritize and troubleshoot issues under pressure. · Strong initiative, ability to work independently and the ability to multi-task. · Strong interpersonal skills, allowing them to work with a variety of roles within the manufacturing plant and analytical organization. · Must be able to work and interact effectively as a member of a team. · Must have the ability to learn and apply technical concepts related to laboratory instruments, sample analyses and data interpretation. · Bachelor's degree in a technical or science field desired. 20 hours College Chemistry or relevant work experience is required. Job Requirements · Follow procedures related to EH&S and to the Analytical Work Process · Adhere to good laboratory practices · Adhere to cGMP and good documentation practices requirements. · Perform routine analyses according to documented procedures · Evaluate correctness of data · Document and communicate laboratory results
    $26k-40k yearly est. 2d ago
  • Laboratory Technician

    Kelly 4.1company rating

    Croydon, PA jobs

    The Associate Analytical Technician supports manufacturing operations by performing laboratory analyses, maintaining analytical systems, and ensuring data integrity. This role is ideal for individuals who are detail-oriented, safety-conscious, and eager to grow in a technical laboratory environment. Key Responsibilities: Train under senior team members to perform routine analyses until proficiency is demonstrated. Collect samples in accordance with the Sample Plan and standard operating procedures. Conduct laboratory analyses to support plant operations and product quality. Evaluate the validity of routine analytical data and take appropriate corrective actions. Monitor analytical systems and escalate issues as needed. Perform basic preventive maintenance and calibration of laboratory instruments. Implement and qualify new analytical equipment and methods. Document, communicate, and archive analytical results and data accurately. Follow Environmental Health & Safety (EH&S) and Operating Discipline Management System (ODMS) procedures. Suggest improvements to laboratory processes, tools, and workflows. Maintain lab cleanliness and inventory through regular housekeeping tasks. Escalate non-routine requests or issues to appropriate team members. Preferred Skills & Qualifications: Understanding of analytical/scientific methods and laboratory best practices. Ability to troubleshoot and adapt to non-routine lab analyses. Familiarity with data systems and statistical evaluation tools. Strong attention to detail and commitment to safety and quality. Effective communication and collaboration skills. Schedule: This Lab Tech position is on a Rotating shift schedule but you will have different hours during training. This position will follow a rotating shift schedule with AM and PM shifts switching every two weeks.
    $35k-53k yearly est. 2d ago
  • Part Time Sample Prep Technician - Rochester-Spencerport NY

    Takeda 4.7company rating

    Rochester, NY 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 About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. Position will be based out of our brand new plasma donation facility in the opening October 2025! BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Responsible for all Sample Processing job skills, including, preparing plasma units for freezing, preparing samples of plasma for testing, and preparing plasma units and samples for shipment. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Provide exceptional customer service to internal and external customers (5%) Perform all required duties in the area of Sample Processing (including, but not limited to): (95%) Prepare units for frozen storage. Collect and store samples from plasma units for testing. Perform routine maintenance on the freezer including monitoring freezer and refrigerator temperatures and removing ice buildup. Prepare frozen plasma units and samples for shipping following established protocol. Organize plasma boxes/documents for scheduled shipments and assist in loading shipments. Manage supplies, assist management team with inventory control procedures, break down empty cartons and assist with proper disposal. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Ability to multi-task and work as a team player. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Innovation Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs. Must be able to occasionally work in a cold environment ranging from -20 C (-4 F) to -40 C (-40F). Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear DUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required Desired: Experience in a laboratory, hospital, or other regulated environment is a plus ADDITIONAL INFORMATION FLSA Classification (US) - Non-Exempt Other duties and responsibilities as assigned. 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 - NY - Rochester U.S. Starting Hourly Wage: $18.00 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 - NY - RochesterWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $18 hourly Auto-Apply 59d ago
  • Part Time Sample Prep Technician - Rochester-Spencerport NY

    Biolife Plasma Services 4.0company rating

    Rochester, NY 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** About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. Position will be based out of our brand new plasma donation facility in the opening October 2025! BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Responsible for all Sample Processing job skills, including, preparing plasma units for freezing, preparing samples of plasma for testing, and preparing plasma units and samples for shipment. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Provide exceptional customer service to internal and external customers (5%) Perform all required duties in the area of Sample Processing (including, but not limited to): (95%) Prepare units for frozen storage. Collect and store samples from plasma units for testing. Perform routine maintenance on the freezer including monitoring freezer and refrigerator temperatures and removing ice buildup. Prepare frozen plasma units and samples for shipping following established protocol. Organize plasma boxes/documents for scheduled shipments and assist in loading shipments. Manage supplies, assist management team with inventory control procedures, break down empty cartons and assist with proper disposal. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Ability to multi-task and work as a team player. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Innovation Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs. Must be able to occasionally work in a cold environment ranging from -20 C (-4 F) to -40 C (-40F). Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear DUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required Desired: Experience in a laboratory, hospital, or other regulated environment is a plus ADDITIONAL INFORMATION FLSA Classification (US) - Non-Exempt Other duties and responsibilities as assigned. **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 - NY - Rochester **U.S. Starting Hourly Wage:** $18.00 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._ **Locations** USA - NY - Rochester **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Part time **Job Exempt** No
    $18 hourly 60d+ ago
  • Formulation and Fill Technician II

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ jobs

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** The Formulation Technician is responsible for the formulation and dispensing of pharmaceutical products in accordance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs) within a clean room environment. This role supports the production of Radio-pharmaceutical and dermatological products and ensures compliance with regulatory standards. **Schedule:** 2nd Shift: Monday - Friday, 1:30pm-10:00pm **Key Responsibilities** + Formulate and dispense pharmaceutical products in a clean room environment, including Radio-pharmaceutical and dermatological products. + Wash and sterilize equipment, tubing, filters, stoppers, vessels, vials, ampoules, and other related components. + Perform both automatic and manual manufacturing processes as required. + Conduct cleaning of manufacturing facilities and equipment to maintain sterile conditions. + Follow all company safety policies and procedures. + Prepare and set up glassware and laboratory equipment to ensure optimal conditions for production. + Accurately document data and review completed batch records to ensure products meet specifications. + Assist in the review and revision of SOPs and batch records as needed. + Monitor equipment under supervision and report any irregularities. + Complete all required documentation in compliance with FDA regulations. + Support the packaging and labeling facility during production downtime. + Perform other duties as assigned. **Work Conditions** + Office, laboratory, and controlled clean room environments. + Exposure to syringes, needles, and other pharmaceutical handling tools. **Physical Requirements** + Ability to stand, walk, sit, use hands and fingers, reach, push, stoop, kneel, crouch, or crawl. + Must be able to talk and hear clearly. + Visual capabilities including close vision, color vision, peripheral vision, depth perception, and ability to focus. + Ability to visually inspect small products and printed materials. + Operate laboratory equipment and office machines. + Wear required safety attire including lab coats and other PPE. + Lift and carry up to 50 lbs. **Travel Requirements** + Travel: None (0%) **Qualifications** **Education:** + High School Diploma or GED required. + Education in life sciences or a technical discipline preferred. **Skills & Competencies:** + Ability to work under direct supervision and follow clearly defined procedures. + Strong organizational and record-keeping skills. + Basic computer proficiency. + High attention to detail. + Effective verbal, written, and interpersonal communication skills. + Ability to visually inspect small products and printed materials. **Experience** + 25 years of related experience preferred. + Familiarity with SOPs, Master Batch Records, and cGMPs preferred. + Basic math, computer, and documentation skills required. + cGMP training is a plus. + Experience with aseptic fill/finish and formulation techniques preferred. + Prior work in a controlled environment and pharmaceutical setting preferred. _Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $34k-46k yearly est. 42d ago
  • Microbiologist

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA jobs

    About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Microbiologist (Full Time) At Nivagen as a Microbiologist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Position Summary As a Microbiologist you will play a critical role in the success of our operations. This position is integral to our commitment to excellence, as it involves developing and validating microbiological test methods, maintaining detailed records, and preparing reports, protocols, and standard operating procedures (SOPs). Your expertise will directly contribute to Quality and affordable medication. Collaboration is key in this role. You will work closely with cross-functional teams to meet project objectives and timelines and identify opportunities for process improvements. Your proactive approach and innovative mindset will help us enhance efficiency and effectiveness within our microbiology laboratory and reinforce our dedication to quality and compliance. Additionally, in this influential role you will be a mentor, providing training and guidance to microbiology staff, fostering an environment of continuous learning and professional growth. Joining Nivagen as a Microbiologist means being part of a visionary team dedicated to expanding access to quality, affordable medication. If you are passionate about quality, service, and innovation, and are eager to make a difference in people's lives, we invite you to bring your expertise and enthusiasm to our dynamic team. Duties and Responsibilities Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing. Develops and validates microbiological test methods in accordance with compendial and regulatory requirements. Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and SOPs related to microbiological activities. Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed. Microbiology-related projects, including method transfers, validations, and investigations. Collaborates with cross-functional teams to achieve project objectives and timelines. Provides training and mentorship to microbiology staff. Shares knowledge and expertise to promote continuous learning and development within the microbiology team. Identifies opportunities for process improvements and optimization within the microbiology laboratory. Implements best practices and innovative solutions to enhance efficiency and effectiveness. Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials. Performs other duties as assigned. While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like BET, Sterility, MLT, Bio Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation. Knowledge and Skills Strong knowledge of microbiological testing techniques, methods, and equipment. Key Competencies Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions. Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement. Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives. Resourcefulness: Secures and deploys resources effectively and efficiently. Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems. Ensures Accountability: Holds self and others accountable to meet commitments and objectives. Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations. Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences. Values People: Our people define who we are as a company. We believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. By prioritizing the well-being and development of our employees, we create an environment where everyone can thrive and contribute their best. Quality: Quality stands at the core of our mission. It reflects our commitment to excellence in every medication we produce. We adhere to the highest standards of quality control and continuously strive to improve our processes to ensure that our products meet the needs of those we serve. Our dedication to quality is unwavering and is evident in every aspect of our work. Service: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service. We are committed to delivering exceptional service and ensuring that every experience with our company is positive and impactful. Our service-oriented approach helps us build strong, lasting relationships and fulfill our mission of improving healthcare outcomes. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care. Innovation drives us to find better ways to serve our patients, improve our products, and streamline our operations. We are committed to staying ahead of industry trends and leveraging cutting-edge technology to enhance the value we provide. In summary, our core values-People, Quality, Service, and Innovation-are integral to everything we do. They guide our actions, shape our culture, and inspire us to achieve excellence in all our endeavors. By staying true to these values, we ensure that we fulfill our mission and make a positive impact on the lives of those we serve. Experience and Qualifications Bachelor's degree in microbiology, Biology, or related field required; Master's degree preferred. Minimum of 3 years of experience in a microbiology laboratory required. Previous experience in a pharmaceutical or compounding environment preferred. Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred. Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity. Benefits: Pay range $70,000-$80,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply. Nivagen Pharmaceuticals does not accept unsolicited résumés from agencies. Submission of any résumé without a signed agreement in place does not create candidate ownership or any obligation to pay fees.
    $70k-80k yearly Auto-Apply 57d ago
  • Microbiologist

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA jobs

    Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Microbiologist (Full Time) At Nivagen as a Microbiologist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Position Summary As a Microbiologist you will play a critical role in the success of our operations. This position is integral to our commitment to excellence, as it involves developing and validating microbiological test methods, maintaining detailed records, and preparing reports, protocols, and standard operating procedures (SOPs). Your expertise will directly contribute to Quality and affordable medication. Collaboration is key in this role. You will work closely with cross-functional teams to meet project objectives and timelines and identify opportunities for process improvements. Your proactive approach and innovative mindset will help us enhance efficiency and effectiveness within our microbiology laboratory and reinforce our dedication to quality and compliance. Additionally, in this influential role you will be a mentor, providing training and guidance to microbiology staff, fostering an environment of continuous learning and professional growth. Joining Nivagen as a Microbiologist means being part of a visionary team dedicated to expanding access to quality, affordable medication. If you are passionate about quality, service, and innovation, and are eager to make a difference in people's lives, we invite you to bring your expertise and enthusiasm to our dynamic team. Duties and Responsibilities Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing. Develops and validates microbiological test methods in accordance with compendial and regulatory requirements. Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and SOPs related to microbiological activities. Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed. Microbiology-related projects, including method transfers, validations, and investigations. Collaborates with cross-functional teams to achieve project objectives and timelines. Provides training and mentorship to microbiology staff. Shares knowledge and expertise to promote continuous learning and development within the microbiology team. Identifies opportunities for process improvements and optimization within the microbiology laboratory. Implements best practices and innovative solutions to enhance efficiency and effectiveness. Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials. Performs other duties as assigned. While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like BET, Sterility, MLT, Bio Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation. Knowledge and Skills Strong knowledge of microbiological testing techniques, methods, and equipment. Key Competencies Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions. Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement. Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives. Resourcefulness: Secures and deploys resources effectively and efficiently. Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems. Ensures Accountability: Holds self and others accountable to meet commitments and objectives. Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations. Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences. Values People: Our people define who we are as a company. We believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. By prioritizing the well-being and development of our employees, we create an environment where everyone can thrive and contribute their best. Quality: Quality stands at the core of our mission. It reflects our commitment to excellence in every medication we produce. We adhere to the highest standards of quality control and continuously strive to improve our processes to ensure that our products meet the needs of those we serve. Our dedication to quality is unwavering and is evident in every aspect of our work. Service: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service. We are committed to delivering exceptional service and ensuring that every experience with our company is positive and impactful. Our service-oriented approach helps us build strong, lasting relationships and fulfill our mission of improving healthcare outcomes. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care. Innovation drives us to find better ways to serve our patients, improve our products, and streamline our operations. We are committed to staying ahead of industry trends and leveraging cutting-edge technology to enhance the value we provide. In summary, our core values-People, Quality, Service, and Innovation-are integral to everything we do. They guide our actions, shape our culture, and inspire us to achieve excellence in all our endeavors. By staying true to these values, we ensure that we fulfill our mission and make a positive impact on the lives of those we serve. Experience and Qualifications Bachelor's degree in microbiology, Biology, or related field required; Master's degree preferred. Minimum of 3 years of experience in a microbiology laboratory required. Previous experience in a pharmaceutical or compounding environment preferred. Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred. Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity. Benefits: Pay range $70,000-$80,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply. Nivagen Pharmaceuticals does not accept unsolicited résumés from agencies. Submission of any résumé without a signed agreement in place does not create candidate ownership or any obligation to pay fees.
    $70k-80k yearly 27d 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 30d 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
  • Formulation and Fill Technician II

    Sun Pharmaceutical Industries 4.6company rating

    Billerica, MA jobs

    Sun Pharma is the world's fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Job Summary: The Formulation Technician is responsible for the formulation and dispensing of pharmaceutical products in accordance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs) within a clean room environment. This role supports the production of Radio-pharmaceutical and dermatological products and ensures compliance with regulatory standards. Schedule: 2nd Shift: Monday - Friday, 1:30pm-10:00pm Key Responsibilities * Formulate and dispense pharmaceutical products in a clean room environment, including Radio-pharmaceutical and dermatological products. * Wash and sterilize equipment, tubing, filters, stoppers, vessels, vials, ampoules, and other related components. * Perform both automatic and manual manufacturing processes as required. * Conduct cleaning of manufacturing facilities and equipment to maintain sterile conditions. * Follow all company safety policies and procedures. * Prepare and set up glassware and laboratory equipment to ensure optimal conditions for production. * Accurately document data and review completed batch records to ensure products meet specifications. * Assist in the review and revision of SOPs and batch records as needed. * Monitor equipment under supervision and report any irregularities. * Complete all required documentation in compliance with FDA regulations. * Support the packaging and labeling facility during production downtime. * Perform other duties as assigned. Work Conditions * Office, laboratory, and controlled clean room environments. * Exposure to syringes, needles, and other pharmaceutical handling tools. Physical Requirements * Ability to stand, walk, sit, use hands and fingers, reach, push, stoop, kneel, crouch, or crawl. * Must be able to talk and hear clearly. * Visual capabilities including close vision, color vision, peripheral vision, depth perception, and ability to focus. * Ability to visually inspect small products and printed materials. * Operate laboratory equipment and office machines. * Wear required safety attire including lab coats and other PPE. * Lift and carry up to 50 lbs. Travel Requirements * Travel: None (0%) Qualifications Education: * High School Diploma or GED required. * Education in life sciences or a technical discipline preferred. Skills & Competencies: * Ability to work under direct supervision and follow clearly defined procedures. * Strong organizational and record-keeping skills. * Basic computer proficiency. * High attention to detail. * Effective verbal, written, and interpersonal communication skills. * Ability to visually inspect small products and printed materials. Experience * 2-5 years of related experience preferred. * Familiarity with SOPs, Master Batch Records, and cGMPs preferred. * Basic math, computer, and documentation skills required. * cGMP training is a plus. * Experience with aseptic fill/finish and formulation techniques preferred. * Prior work in a controlled environment and pharmaceutical setting preferred. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
    $49k-67k yearly est. 43d 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 2d ago
  • Experienced Microbiologist

    Capsugel Holdings Us 4.6company rating

    Bend, OR jobs

    Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lonza Pharma & Biotech is seeking an experienced Microbiologist to join our team in Bend, OR. This role offers the opportunity to contribute to cutting-edge pharmaceutical development in a collaborative and fast-paced environment. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Opportunities for professional growth and development. Supportive team environment with strong collaboration. Access to Lonza's global benefits program. Key Responsibilities: Sample and test raw materials and final products. Conduct microbial analysis for environmental monitoring. Perform basic laboratory operations and documentation. Operate analytical and monitoring instruments. Develop, validate, and transfer analytical methods. Write and review SOPs and test notes. Support cleaning sample testing and other duties. Key Requirements: Bachelor's degree in a science-related field. Experience in GMP facility preferred. Extensive experience in analytical or biology labs. Ability to handle hazardous materials safely. Comfortable working in small areas and lifting occasionally. Able to wear personal protective equipment. Available to work 4x10 hour shifts, Sunday to Wednesday. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $37k-51k yearly est. Auto-Apply 23d ago
  • Microbiologist

    LNK International, Inc. 4.1company rating

    Hauppauge, NY jobs

    LNK International, Inc. is one of the nation's largest manufacturers of solid and liquid dose, over-the-counter (OTC) pharmaceuticals. For over 40 years, we have built a reputation for delivering the highest quality products, outstanding service and product innovation. What sets LNK apart? We believe it is our employees. From our lab scientists who assists in various experiments and research, working under the direction of lead scientists and researchers to develop new analytical methods and techniques, as well as reviewing and interpreting results to provide insights and recommendations for further research. Our full time employees enjoy competitive benefits including: 401(k) with generous employer match Health Insurance Dental Insurance Paid holidays Paid vacation As a microbiologist you will work with and collaborate with a talented and dedicated group of experts. Job Description: Perform Media Preparation with growth promotion. Maintain stock cultures weekly in the lab for positive controls. Perform Water testing using the Water filtration method Perform general micro lab duties and housekeeping including glassware cleaning and preparation. Perform calibration and monthly maintenance of different equipment. Perform Environmental Monitoring of all zones of the micro lab. Sterilize biohazardous material by running autoclave cycles. Perform Microbial limits on solid and liquid finished products at LNK International, Inc Perform Antimicrobial Effectiveness testing on Liquid Products. Prepare final reports. Conduct and write Investigation reports for Out of Specification results. Writing/ reviewing procedures. Perform Microbial identification as per procedures. Checking USP for any change in specification and/ or procedure. Monitoring the microbiology laboratory testing and reviewing of other microbiologist(s) work. Perform microbial testing on active and excipients of raw materials using USP/In-House method. Requirements Bachelor's degree. Preference will be given to candidates with experience in the pharmaceutical field. Excellent communications and presentation skills - written and verbal; fluent in English. The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law. LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable federal, state or local laws. Job Posted by ApplicantPro
    $43k-59k yearly est. 17d 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 42d ago
  • Microbiologist

    Zoetis 4.9company rating

    Atlanta, GA jobs

    What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose ‘to nurture the world and humankind by advancing care for animals,' is what unites us in all our roles. We are a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than one hundred countries. And we are excited to become a part of the Lithia Springs, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios. We are currently searching for a Microbiologist to join our team. Summary The Quality Controls Laboratory group conducts routine testing for manufactured products. Qualified Microbiologist applicants would have expertise in performing microbiological laboratory procedures in compliance with specifications in Standard Operating Procedures and Standard Test Procedures used to support testing and release of product. Additional skills of interest include microbial assay validation and troubleshooting, proven ability to train team members, project management and report writing. Position Responsibilities Perform complex routine laboratory testing independently Interact with interdepartmental customers such as Manufacturing, Regulatory, and Quality Assurance Perform laboratory testing associated with transfer projects Perform trouble shooting and problem solving for routine tests and processes Demonstrate expertise and participate in laboratory responsibilities, including training, paperwork review and approval and laboratory investigation support. Assist supervisor with daily decision-making using data, good judgment, and experience Work with Maintenance and Engineering to improve laboratory and equipment operation Proceduralize processes using standard work concepts Participate in outline reviews as a SME reviewer, provide SAP data extracts and perform routine data analytics using basic statistical analysis. Provide support for routine laboratory activities outside of testing including LEAN projects and Critical Reagent Management. Education and Experience B.S. or equivalent in Biological Sciences or closely related field and 5 - 7 years' experience in a microbiological laboratory Experience performing / troubleshooting / developing microbiological assays. Exceptional Organizational, Communication and Interpersonal skills. Technical Skills and Competencies Required Minimum Qualifications: Understanding of Biological and Chemical Processes common to Quality Control Testing Understanding of Biological Regulatory Requirements and Licensure Process Self-starter, able to prioritize work and work efficiently with minimal supervision Complete calculations using basic math Understand metric system and basic statistics Ability to solve practical problems with a variety of concrete variables Ability to make logical decisions concerning team and department issues Ability to make laboratory decisions in absence of supervision Ability to recognize product quality issues based on company guidelines Ability to train colleagues on both basic fundamentals and technical aspects of microbiological assays. Preferred Qualifications: Advance understanding of microbiology Existing knowledge of FDA, USDA, EMA, and compendial requirements associated with Quality Control assay development and testing Proven project and time management experience including technical writing of protocols and reports Physical Position Requirements Manual dexterity using hands and fingers This job entails sitting or standing at a laboratory bench or desk. Specific vision abilities required by this job include close vision work Occasional need to sit, reach with hands and arms Ability to work flexible hours, work weekend and overtime Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $66k-82k yearly est. Auto-Apply 32d ago
  • Microbiologist

    Eurofins Scientific 4.4company rating

    Sample prep technician job at Eurofins

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description * Applies GMP/GLP in all areas of responsibility, as appropriate * Demonstrates and promotes the company vision * Regular attendance and punctuality * Performs laboratory operations with good dexterity, good laboratory techniques, and high degree of accuracy and precision * Prepares reagents, samples, and standards according to procedures * Documents testing, observations, deviations, and results clearly and completely * Understands and performs calculations as required by test methods * Understands and utilizes computers for information access, calculations, and report preparation * Reads and understands analytical procedures (compendial and client supplied) and internal SOPs * Commitment to occasional overtime as workload requires; works overtime and/or adjusts working hours when necessary to meet client requirements * Trains others in laboratory procedures * Performs laboratory maintenance * Communicates with vendors and repair personnel * Performs laboratory work on weekends and holidays on a rotating basis with other members of the department * Due to the size of the site, employees are required to flex into positions and activities outside their normally assigned duties as workload requires and as trained. These activities require working in all departments including QA, microbiology, chemistry, and general support for laboratory operations. Qualifications The Ideal Candidate would possess: * Strong computer, scientific, and organizational skills * Excellent communication (oral and written) and attention to detail * Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude * Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Minimum Qualifications: * Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration and some laboratory experience * Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Position is full-time, Monday - Friday 3pm - 11pm. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply. * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
    $42k-62k yearly est. 3d ago

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