Scientific Results Section Example Jobs in Usa
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Summary:Assists the Laboratory Resources Coordinator with various duties as assigned. Responsible for maintaining adequate supply inventory levels for all laboratory departments. Responsible for receiving inventory, stocking inventory, reconciliation of packing slips, and resolution with vendors. Performs all forms of clerical duties as assigned.Responsibilities:
Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
Assists with maintaining adequate supply inventory levels for all laboratory departments by performing weekly, bi-monthly, and monthly inventory, as assigned.
Responsible for receiving inventory, stocking inventory, and reconciliation of packing slips. Responsible for problem resolution with vendors, and other entities, as assigned.
Assists with supply orders by entering into the HSS ordering system;
places orders to the vendor, as assigned.
Assists with completing monthly reports, as assigned.
Assists with the processing and maintenance of laboratory records and reports;
audits/reconciles invoices, as assigned.* Assists with obtaining demographic information for STD reports;distributes/files as required.
Miscellaneous duties such as copying, scanning, printing, organization of files, filing, etc. Creates correspondence, letters, and memos as requested. Creates graphs and meeting materials for presentation via Excel, PowerPoint, Visio, Publisher, and Word software, as requested.
Works as a team member to perform and complete all assignments, to provide timely results on a daily basis. Completes tasks or special projects within the time frame allowed per any guidelines established as assigned by Laboratory Resources Coordinator, Section Supervisor, Manager, or Director.
Continuing education and development - attends, listens by tape, or reads material of 10-12 in-house educational programs per year.
Practices safety, infection control, and security as defined by the hospital department and section policy and procedure manuals;
follows all safety and infection control procedures including wearing appropriate PPE for assigned job functions;disposes of biohazardous materials and hazardous chemicals as established by the departmental policy;all patient information, including lab results, are maintained in the strictest of confidence, limited to health care professionals needing this information to perform patient care.* Follows and adheres to HIPAA laws and regulations;follows and adheres to privacy & confidentiality laws and regulations specifically relating to personnel issues, personnel file contents, etc. in addition to all patient information.
Job Requirements:
Education/Skills
* High School Diploma or equivalent preferred
Experience
* None Required
Licenses, Registrations, or Certifications
* None required
Work Schedule:
MULTIPLE SHIFTS AVAILABLEWork Type:
Part Time
Summary:
Is trained to perform processing blood and other body fluids, sendouts, and other tests as required. Obtains blood samples from the correct patient, ensuring that the blood is properly drawn and labeled following established procedures to assure the proper specimen for the requested testing. Is trained to become competent at venipunctures and skin punctures. May register and interview patients, obtaining accurate demographic and financial information. May be required to verify medical necessity for all Medicare patients.
Responsibilities:
* Performs daily phlebotomy procedures and tests on a fluctuating work schedule. Obtains an adequate specimen on all patients, including correct timed specimens when indicated.
* Observes established personnel policies, OSHA requirements, and lab procedures to ensure safe practice.
* Assures proper identification of patient and specimens in accordance with established laboratory identification procedures, and cares for patients promptly and courteously.
* Maintains integrity of specimens while processing specimens. Assures correct identification of specimens and distributes specimens to the proper department or correct reference laboratory.
* Plates and smears to appropriate media all specimens received for culturing. Processes microbiology specimens when assigned.
* Processes sendout testing when necessary.
* Answer Pneumatic tube system at all times.
* Assists in orienting of new personnel as directed by the lead tech or lab director.
* Continuously practices universal precautions. Follows all hospital, section, and safety policies and procedures.
* Is trained in the following skills: Age specific criteria for all age groups, fingersticks, heel sticks, venipuncture, blood cultures, syringe collections and the use of butterflies
* Registers and interviews patients, obtaining accurate demographic financial information.
* Performs therapeutic phlebotomies
* Stock drawing stations and outpatient rest rooms. Maintain phlebotomy area, trays area in orderly and useable condition. Maintains a system of inventory control of assigned areas. Assumes responsibility for neatness and cleanliness of patient area.
* Follows hospital safety policy including wearing gloves while performing phlebotomy and utilizes only safeguard needles and syringes. Follows needlestick policy in the event of needlestick or mucous membrane exposure.
* Contacts patients or nursing stations for additional specimens, if necessary.
* Performs daily clerical duties which may include entering results into computer, receiving specimens, answering the telephone, printing logs, looking up results, monitoring label printing, problem solving and assisting office personnel as needed.
* Reports to CLS, CLT, or Supervisor any irregularities encountered in performing daily workload.
* Maintains a clean work area.
* Helps to unpack and distribute laboratory supplies.
* Performs other duties as assigned.
Requirements:
Education:
* High school diploma or equivalent.
Experience:
* Relevant experience preferred.
* Ability to register patients, obtain specimens and dispense critical information in accordance with section, laboratory, and hospital policies and procedures. Must be able to read and write English and be able to communicate effectively. Must be able to operate laboratory equipment, computer systems.
Certifications, Registrations, or Licenses:
* N/A
Work Schedule:
MULTIPLE SHIFTS AVAILABLE
Work Type:
Full Time
Obtains blood samples from the correct patient, ensuring that the blood is properly drawn and labeled following established procedures to assure the proper specimen for the requested testing.
Is trained to become competent at venipunctures and skin punctures.
May register and interview patients, obtaining accurate demographic and financial information.
May be required to verify medical necessity for all Medicare patients.
Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
Performs daily phlebotomy procedures and tests on a fluctuating work schedule.
Obtains an adequate specimen on all patients, including correct timed specimens when indicated.
Observes established personnel policies, OSHA requirements, and lab procedures to ensure safe practice.
Assures proper identification of patient and specimens in accordance with established laboratory identification procedures, and cares for patients promptly and courteously.
Maintains integrity of specimens while processing specimens.
Assures correct identification of specimens and distributes specimens to the proper department or correct reference laboratory.
Plates and smears to appropriate media all specimens received for culturing.
Processes microbiology specimens when assigned.
Processes sendout testing when necessary.
Answer Pneumatic tube system at all times.
Assists in orienting of new personnel as directed by the lead tech or lab director.
Continuously practices universal precautions.
Follows all hospital, section, and safety policies and procedures.
Is trained in the following skills: Age specific criteria for all age groups, fingersticks, heel sticks, venipuncture, blood cultures, syringe collections and the use of butterflies Registers and interviews patients, obtaining accurate demographic financial information Performs therapeutic phlebotomies Stock drawing stations and outpatient rest rooms.
Maintain phlebotomy area, trays area in orderly and useable condition.
Maintains a system of inventory control of assigned areas.
Assumes responsibility for neatness and cleanliness of patient area.
Follows hospital safety policy including wearing gloves while performing phlebotomy and utilizes only safeguard needles and syringes.
Follows needlestick policy in the event of needlestick or mucous membrane exposure.
Contacts patients or nursing stations for additional specimens, if necessary.
Performs daily clerical duties which may include entering results into computer, receiving specimens, answering the telephone, printing logs, looking up results, monitoring label printing, problem solving and assisting office personnel as needed.
Reports to CLS, CLT, or Supervisor any irregularities encountered in performing daily workload.
Maintains a clean work area.
Helps to unpack and distribute laboratory supplies.
Performs other duties as assigned.
Job Requirements: Education/Skills High school diploma or equivalent.
Ability to register patients, obtain specimens and dispense critical information in accordance with section, laboratory, and hospital policies and procedures.
Must be able to read and write English and be able to communicate effectively.
Must be able to operate laboratory equipment, computer systems.
Experience Relevant experience preferred.
Licenses, Registrations, or Certifications None required.
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule: MULTIPLE SHIFTS AVAILABLE Work Type: Full Time
Work Location: North Chicago, IL 60064
Assignment Duration: 12 Months (possible conversion)
Work Schedule: The 3rd shift will be 4x10hr shifts either Sunday-Wednesday or Wednesday-Saturday from 10pm-8:30am. Training for the first 3-6 months will be on first shift. Once training is completed they will get a 15% shift differential for moving to 3rd shift.
Work Arrangement: 100% onsite
Position Summary: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications.
Background & Context: Acts as a team member in the API/ Raw Material/ In-Process/Drug Product testing laboratories.
Key Responsibilities:
- Independently performs and verify a multitude of laboratory techniques for which they are trained on while adjusting to unforeseen technical or logistical obstacles to accomplish assignments.
- Understands multiple laboratory techniques and principles and can independently trouble-shoot and resolve analytical techniques and instrument issues.
- Takes initiative to be a key player in team activities and decision making including proactive identification, development, and implementation of improvement plans.
- Budgets their time independently and effectively to carry out assigned tasks and makes recommendations for improvement.
- Recognizes obstacles to completion of assigned testing and can independently resolve them. Consistently achieves commitments despite obstacles.
- Takes ownership of special projects as needed to support overall laboratory needs and requirements.
- Communicates proactively with supervisor and team members on frequent basis to ensure timely product release.
- Interfaces with regulatory agencies during audit activities as needed.
Qualifications & Experience:
- Bachelor's Degree in the sciences with 0-4 years of laboratory experience
- Associate degree with at least 3 years of laboratory experience
- Flexibility in shift and workdays highly desirable
- Ability to work with general supervision but effectively manages their own time to multi-task based upon their completed training matrix.
- Good interpersonal, documentation, and communication skills.
- Desired technical competencies (not all required): LC, LCMS, GC, GCMS, ICP, Empower, Karl Fischer, dissolution, IR, titrations, and common wet chemical testing
Location: Biologics Pilot Lab - Foster City, CA
Duration: 12 months
Schedule: Onsite (Occasional weekend hours will be required)
Description:
About the Role
Join our Biologics Pilot Lab and contribute directly to the development, scaleup, and pilot-scale production of early and late-stage biologic programs. In this role, you will execute downstream purification operations, support upstream activities as needed, and help advance programs that are central to client biologics pipeline. This position is ideal for candidates who are hands-on in the lab, collaborative, and excited to work on fast moving development efforts.
About the Team
- You will join a team of seven scientists responsible for producing pilot-scale biological products that support biologics programs, trouble shooting and improving processes. The team implements new technologies to enhance operational capability, capacity, and efficiency across the site.
Key Responsibilities
- Technical & Operational
- Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
- Support upstream operations as needed to ensure seamless end-to-end process execution.
- Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
- Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.
- Communication & Collaboration
- Present data, results, and conclusions in group meetings and cross functional discussions.
- Communicate technical information clearly and effectively to colleagues at varying levels.
- Work with a team-oriented, collaborative, and solutions-focused mindset.
- Maintain a strong safety focus in all laboratories and pilot operations.
Required Qualifications
- Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
- Proficiency with AKTA systems and UNICORN programming.
- Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
- Strong verbal communication, technical writing, and documentation skills.
- Ability to work effectively in cross functional teams and in a dynamic environment.
- Self-motivated, organized, and comfortable with scientific problem solving.---
Preferred Qualifications
- Experience in pilot plant operations for biologics in a single-use facility.
- Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles.
Education
- AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
- BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.
Work Requirements
This is a 100% onsite role in Foster City, CA.
Occasional weekend work required to support pilot-scale biologics operations.
Reason for Opening: Increased business needs and workload when FTEs are not available to meet timelines.
Interview Process
- Initial Zoom screening, followed by 1:1 interview with the hiring manager and 1-2 team members.
Onsite Offsite
- Onsite
LocationAtlanta, Georgia
Full/Part TimeFull-Time
Regular/TemporaryRegular
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About Us
Overview
Georgia Tech prides itself on its technological resources, collaborations, high-quality student body, and its commitment to building an outstanding and diverse community of learning, discovery, and creation. We strongly encourage applicants whose values align with our institutional values, as outlined in our Strategic Plan. These values include academic excellence, diversity of thought and experience, inquiry and innovation, collaboration and community, and ethical behavior and stewardship. Georgia Tech has policies to promote a healthy work-life balance and is aware that attracting faculty may require meeting the needs of two careers.
About Georgia Tech
Georgia Tech is a top-ranked public research university situated in the heart of Atlanta, a diverse and vibrant city with numerous economic and cultural strengths. The Institute serves more than 45,000 students through top-ranked undergraduate, graduate, and executive programs in engineering, computing, science, business, design, and liberal arts. Georgia Tech's faculty attracted more than $1.4 billion in research awards this past year in fields ranging from biomedical technology to artificial intelligence, energy, sustainability, semiconductors, neuroscience, and national security. Georgia Tech ranks among the nation's top 20 universities for research and development spending and No. 1 among institutions without a medical school.
Georgia Tech's Mission and Values
Georgia Tech's mission is to develop leaders who advance technology and improve the human condition. The Institute has nine key values that are foundational to everything we do:
- Students are our top priority.
- We strive for excellence.
- We thrive on diversity.
- We celebrate collaboration.
- We champion innovation.
- We safeguard freedom of inquiry and expression.
- We nurture the wellbeing of our community.
- We act ethically.
- We are responsible stewards.
Over the next decade, Georgia Tech will become an example of inclusive innovation, a leading technological research university of unmatched scale, relentlessly committed to serving the public good; breaking new ground in addressing the biggest local, national, and global challenges and opportunities of our time; making technology broadly accessible; and developing exceptional, principled leaders from all backgrounds ready to produce novel ideas and create solutions with real human impact.
About the School of Electrical and Computer Engineering (ECE) at the Georgia Institute of Technology
The School of Electrical and Computer Engineering (ECE) at the Georgia Institute of Technology is one of the largest producers of electrical engineers and computer engineers in the United States. Almost 2,600 students are enrolled in the School's graduate and undergraduate programs, and in the last academic year, 801 degrees were awarded. All ECE undergraduate and graduate programs are in the top five of the most recent college rankings by U.S. News & World Report.
In addition to the main campus in Atlanta, Georgia, ECE also has permanent operations at Georgia Tech-Lorraine in France and Georgia Tech-Shenzhen in China. Graduate students who spend at least one semester each at three Georgia Tech locations (Atlanta, Lorraine, and Shenzhen on three continents (North America, Europe, and Asia) can earn the Georgia Tech Global Engineering Immersion Program (GEIP) Certificate when they receive the Georgia Tech M.S. degree.
Over 110 ECE faculty members are involved in 11 areas of research and education: bioengineering, computer systems and software, digital signal processing, electrical energy, electromagnetics, electronic design and applications, nanotechnology, optics and photonics, systems and controls, telecommunications, and VLSI systems and digital design: and the School is either home to or a key player in almost 20 research centers and consortia.
ECE is key to Georgia Tech's growing reputation as an internationally recognized educational and research and development university. ECE is firmly committed to sustaining excellence in traditional areas of strength and venturing into burgeoning areas of opportunity.
Location
Atlanta, GA
Job Summary
The School of Electrical and Computer Engineering is seeking to hire Research Scientist.
Responsibilities/Duties:
- Conceive, plan, and conduct individual research in broad areas relevant to the mission of the laboratory (imaging, therapy and contrast/therapeutic agents.
- Serve as the technical lead for the laboratory in your area of expertise.
- Plan and direct a number of collaborative research projects including coordination of research activities between groups and disciplines.
- Develop new instruments, materials, processes, scientific methods, approaches and algorithms.
- Responsible for directing others; plans, organizes, and supervises the work of laboratory scientists, engineers, and technicians. Evaluate progress and results obtained, recommend major changes to achieve overall objectives.
- Participate in strategic planning; key role in identifying and acquiring research funding.
- Review schedules, cost and documentation to ensure success of projects.
- Perform other related duties as assigned.
Required Qualifications
Bachelor's Degree
Preferred Qualifications
- Experience in optics, ultrasound, imaging and instrumentation.
- Training in optics/photonics and acoustics.
- Practical experience in area of laser-tissue interaction, ultrasound and photoacoustic imaging.
- Proficiency with modern laboratory equipment such as solid-state and gas lasers, ultrasound transducers and arrays, computer acquisition systems, motion control systems, etc.
- Experience in mechanical design automation applications such as SolidWorks.
- Experience in optical design automation applications such as Zemax.
Contact Information
For additional information about this job opening, please contact :
- Linda Dillon, at
- Lucretia Allen, at
- Shalonda Williams,
USG Core Values
The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found on-line at policymanual/section8/C224/#p8.2.18_personnel_conduct.
Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found on-line at policymanual/section6/C2653.
Equal Employment Opportunity
The Georgia Institute of Technology (Georgia Tech) is an Equal Employment Opportunity Employer. The University is committed to maintaining a fair and respectful environment for all. To that end, and in accordance with federal and state law, Board of Regents policy, and University policy, Georgia Tech provides equal opportunity to all faculty, staff, students, and all other members of the Georgia Tech community, including applicants for admission and/or employment, contractors, volunteers, and participants in institutional programs, activities, or services. Georgia Tech complies with all applicable laws and regulations governing equal opportunity in the workplace and in educational activities.
Georgia Tech prohibits discrimination, including discriminatory harassment, on the basis of race, ethnicity, ancestry, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, national origin, age, disability, genetics, or veteran status in its programs, activities, employment, and admissions. This prohibition applies to faculty, staff, students, and all other members of the Georgia Tech community, including affiliates, invitees, and guests. Further, Georgia Tech prohibits citizenship status, immigration status, and national origin discrimination in hiring, firing, and recruitment, except where such restrictions are required in order to comply with law, regulation, executive order, or Attorney General directive, or where they are required by Federal, State, or local government contract.
More information on these policies can be found here: policymanual/section6/c2714 Board of Regents Policy Manual | University System of Georgia ( ).
Background Check
The candidate of choice will be required to pass a pre-employment background screening. employment/pre-employment-screening.
Kelly® Science & Clinical is seeking Bioanufacturing Associates for multiple direct hire opportunities with one of our clients, a biotechnology company that develops and manufactures novel synthetic DNA tools at its state-of-the-art manufacturing facility in Wilsonville, OR. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay rate: $21/hour + shift differential + overtime
Schedule:
- 2A: Alt Saturday, Sunday - Tuesday (7:00 pm-7:30 am)
- 2B: Wednesday - Friday, Alt Saturday (7:00 pm-7:30 am)
Workplace: Onsite in Wilsonville, OR
Overview
We are looking for motivated Bioanufacturing Associates for one of our clients, a biotechnology company that developed a disruptive synthetic biology technology. The incumbent will perform basic molecular biology workflows in a highly automated, high-throughput manner and will be responsible for the manufacture of a variety of custom oligonucleotide products. The ideal candidate will be able to work independently, be very neat and organized, have the ability to follow established SOPs, and complete manufacturing batch records to contribute to the daily production schedule. The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast-paced start-up environment. The Manufacturing Associate will be responsible for the production of custom gene-based products and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. They will uphold standards as defined by the manufacturing process, work on continuous improvement and have good time management resulting in efficiency, and work in a safe manner.
Responsibilities
- Manufacture high-quality custom oligo-containing products in a high-throughput manufacturing lab according to established SOPs.
- Operation of robotic laboratory equipment and traditional lab equipment (bioanalyzers, centrifuges, sealers, thermocyclers, spectrometers, HPLCs, Next-Generation Sequencing, etc.)
- Daily use of traditional molecular biology processes and techniques, especially PCR, DNA quantitation and handling, and DNA purification
- Maintaining thorough, accurate, and detailed documentation of all work produced in batch records, databases, or other acceptable formats, including problems and deviations
- Updating and writing work instructions and documentation
- Ability to work independently and in a safe manner
- Attention to detail for process consistency
- Documentation, troubleshooting, and addressing process deviations
- Packaging products
- Ability to work in an ISO, GMP, LEAN manufacturing environment and follow the lean manufacturing concepts
- Daily completion of assigned tasks to keep manufacturing on track
Qualifications
- Bachelor's/Associate's degree in biology, chemistry,or biochemistry: degree preferred, but will consider candidates with relevant laboratory experience
- Familiarity or prior experience in a manufacturing environment
- Good written and verbal skills
- Attention to details
- Good computer skills and comfort in using computers for all aspects of manufacturing, experience with Excel and Word, Jira/Confluence, and web-based or similar programs
Are you looking to work on cutting-edge science with real-world impact? This is a unique opportunity to join an innovative, fast-growing startup developing sustainable protein and next-generation biomaterials. You'll work alongside passionate, forward-thinking leaders in a collaborative, high-energy environment—while gaining hands-on experience with advanced molecular biology and strain engineering techniques.
If you're excited by breakthrough science, sustainability, and the chance to make a tangible impact early in your career, this role is for you.
What You'll Do
- Design and execute molecular biology experiments to engineer fungal strains (gene knockouts, knock-ins, overexpression, gene editing)
- Perform RNA-based workflows including extraction, library prep, sequencing, and data analysis
- Conduct RT-PCR and qPCR for gene expression analysis
- Construct and validate plasmids for gene expression and transformation
- Lead fungal transformation efforts and optimize strain performance
- Characterize engineered strains (growth, metabolic output, stress tolerance, etc.)
- Support small-scale fermentation experiments and high-throughput screening
- Analyze experimental data using statistical and bioinformatics tools
- Maintain detailed documentation and present findings to internal teams
What We're Looking For
Required:
- Bachelor's degree in Microbiology, Molecular Biology, Biotechnology, Biochemistry, or related field
- 2+ years of hands-on lab experience in molecular biology (academic or industry)
- Strong experience with:
- RNA sequencing workflows (extraction, library prep, analysis, visualization)
- RT-PCR and qPCR techniques
- Designing and executing genetic modification experiments
- Proven ability to document experiments and communicate results clearly
Preferred:
- Master's degree in a related scientific field
- Experience working with yeast or fungal systems
Why This Role Stands Out
- Work on groundbreaking applications in sustainable protein and biomaterials
- Be part of a startup environment—fast-paced, collaborative, and full of opportunity to learn
- Gain exposure to advanced molecular techniques and real product development
- Work with engaging, supportive leadership who are invested in your growth
- Contribute to innovative projects shaping industries from food to fashion
Details
- Schedule: Flexible (8:00–4:30 or 9:00–5:30)
- Compensation: $27–$30/hour
- Duration: 6-month contract with potential for extension
Position: Associate Director, Clinical Quality Compliance
Location: Bedford, MA (On-site 3 days/week)
Length: 6 Month Contract
Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.
Job Description:
The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.
Essential Duties and Responsibilities:
- Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
- Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
- Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
- Participate in the development of GCP/GLP auditing strategies.
- Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
- Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
- Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.
Qualifications:
- BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
- Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
- Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
- Ability to work autonomously, effectively manage time and deliver results on time.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Conflict resolution/management and negotiation skills.
- Ability to manage multiple projects in a fast-paced environment.
- Excellent organizational, interpersonal, verbal, and written communication skills.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!
# 18352
Job Title: Senior Analyst, QC Chemistry
Work Location: Mercer County, New Jersey
Summary:
Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and internal processes and procedures.
Responsibilities:
- Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations.
- Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures.
- Lead troubleshooting efforts for analytical methods and instrumentation related to CE.
- Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
- Implement corrective actions and preventive actions (CAPAs).
- Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
- Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc.
- Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed.
- Manage inventory of reagents and supplies for the laboratory.
- Participate in internal and external GMP audits, as needed.
- Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis.
- Serving as subject matter expert in one or more areas of required testing.
- Undertake other duties as required.
Qualifications:
- Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
- Minimum of 4+ years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
- CE experience is an absolute must have.
- Familiar with Waters Empower Chromatography Data System.
- Familiar with instrument and equipment validation.
- Working knowledge with USP/EP and cGMP/EU GMP regulations.
- Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
- Must be willing to travel approximately 10%.
- Ability to work on a computer for extended periods of time.
