Quality Control Scientist
Quality control analyst job in Indianapolis, IN
Job Responsibilities:
Develop, evaluate, and optimize the QC method transfer program for both analytical and microbiological assays.
Assess incoming client methods and compendial test methods for raw materials, container/closures, APIs, in-process samples, and finished products, determining suitability with existing laboratory capabilities and identifying any additional instrumentation or reagents required.
Collaborate with clients and internal teams to plan, review, approve, and execute method transfers into the laboratory.
Work closely with the Quality team to maintain and enhance laboratory safety programs and promote a quality-driven culture.
Maintain rigorous scientific and quality standards, ensuring accuracy, reproducibility, and compliance in all laboratory activities.
Coordinate resources, scheduling, and logistics to support client testing needs, including microbiological sampling, laboratory instruments, and personnel availability.
Ensure laboratory readiness for inspections, audits, and regulatory compliance by applying knowledge of cGMP, cGLP, and other regulatory standards.
Lead and support investigations for out-of-specification (OOS), out-of-trend (OOT), and other non-conformance events using troubleshooting and corrective action processes.
Manage laboratory documentation and technical records throughout their lifecycle, including authoring, reviewing, approving, and retiring procedures and reports, utilizing both manual and automated systems.
Qualifications:
Bachelor's degree in Biology, Microbiology, Biochemistry, or related field.
5+ years of experience in microbiology or related roles within GMP manufacturing or QC laboratory testing.
Practical experience implementing FDA, EMA, and other regulatory authority expectations for QC, particularly regarding method development and method transfer.
Proficiency with laboratory instrumentation and automated data management systems (e.g., LIMS, JMP, Minitab).
Quality Control Chemist
Quality control analyst job in Indianapolis, IN
The QC Chemist will support all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications
Key Responsibilities: Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results.
Escalation in case of non-conformances and deviations and manage these quality incidents as per procedures.
Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions.
Participation in assigned qualification/validation activities, as necessary.
Responsible for successful on time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role.
Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices. Support internal and external Audits and Inspections, as required.
Essential Requirements: Education: Bachelors' degree required in relevant Scientific discipline (e.g Chemistry, Microbiology).
Minimum of 3-year experience in cGMP or aseptic environment required. Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques.
Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies preferred HPLC knowledge is required.
Ability to interpret analytical data and convert into technical documentation.
Chemist
Quality control analyst job in Indianapolis, IN
• There is an opportunity at Client for a scientist to serve as Analytical Lab Technician in the Regulatory Analytical Sciences Team within Global Regulatory Sciences R&D.
Primary Responsibilities
Assists in the receiving, weighing and extraction of samples within a study to support product registration and to develop biologically active research chemicals. Supports laboratory testing and data generation as outlined by the principal investigators for the Regulatory Analytical Sciences residue studies.
Support experimental lab routine operations such as sample shipments, sample receiving, sample weighing, consumable ordering, etc.
Prioritize daily work activities to meet timelines.
Interact regularly with LIMS (Laboratory Information Management System) and with an assortment of automated equipment such as liquid handlers.
Follow specific protocols to perform routine lab support tasks including the following:
Solution preparation
Sample processing
Sample aliquotting
Sample extraction
Equipment and assay maintenance
Operate laboratory instrumentation, including balances, genogrinders, centrifuges, gas chromatographs, high performance liquid chromatographs, and mass spectrometers. Interface with instrument/equipment owners and the Lab Operations team to maintain system performance and minimize downtime.
Complies with all laboratory safety procedures, GLP Standards, and all other study-specific or pertinent regulatory agency requirements Documents activities in the required manner. Maintenance of neat, accurate, and complete records.
As needed, follow Good Laboratory Procedures (GLP) and prepare related support documentation.
Required Qualifications:
Minimum of an Associate Degree in a science related field, BS preferred.
General knowledge of chemistry.
An understanding of computers and laboratory techniques is desirable.
Ability to conduct research and provide high-quality, finalized data in a fast-paced, time sensitive environment.
Preferred Qualifications:
Experience with quantitative weighings, extractions and sample clean-up techniques from various complex agricultural matrices.
Quantitative LC-MS/MS analytical experience in small molecules.
An understanding of GLP regulations.
Excellent interpersonal skills. Must be able to effectively interact with a diverse group of customers, peers, and R&D regulatory and residue experts
INCOG BioPharma Services Careers - QC Method Transfer Scientist, Chemistry
Quality control analyst job in Fishers, IN
This role will be a key member of the INCOG Quality Control laboratory team who has a passion for learning, collaborating, and contributing to the success of our clients. The Method Transfer Scientist will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for our clients.
The Method Transfer Scientist will work closely with Quality Control leadership and will develop and lead the program for performing method transfer for analytical and/or microbiological assays from client laboratories into the INCOG QC Laboratories. The Method Transfer Scientist will be committed to operating with a Quality Mindset in every aspect of their role, including attention to detail, on time delivery, and efficiency.
Essential Job Functions:
* Lead the development and implementation of the INCOG QC Method Transfer program for both analytical and microbiological assays.
* Perform assessments of both incoming client methods and compendial test methods for raw materials, container/closures, API/BDS, in-process, and finished products for suitability with existing INCOG laboratory capabilities to identify if additional chemicals or instruments are required.
* Partner with customers to develop, review, approve, and execute method transfer into the chemistry and/or microbiology laboratory.
* Collaborate with the Quality Team on building laboratory safety program to ensure a safe and quality-minded environment for all personnel working in the laboratory.
* Holds self and others accountable for rigorous scientific and quality work standards.
* Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
* Maintain a constant state of safety and inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
* Support laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
* Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Special Job Requirements:
* Be available to participate in client meetings that may go outside of standard business hours (Monday-Friday 8 AM-5 PM)
* Use applied statistics to analyze and track test results to identify sources of variability and error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
* Maintain regulatory intelligence on the regulatory landscape, policies, and pharmaceutical industry trends through continuous education, networking, literature, trade organizations, etc.
* Be available to support routine QC testing for raw materials, API/BDS, container/closures, in-process, finished products, and environmental monitoring as needed, even on alternate shifts.
* 5+ years of microbiology, chemistry, or other related experience in GMP manufacturing/GMP QC testing of pharmaceuticals.
* Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, particularly related to method development and method transfer.
* Experience with using laboratory instrumentation from pH/conductivity meters, osmometers, and density meters to more complicated systems used for UHPLC/HPLC, GC, CE, and ic IEF analysis.
* Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, OpenLab CDS, ChemStation, etc.).
* Ability to author scientifically sound SOPs, Work Instructions, Transfer Protocols and Summary Reports.
* B.S./B.A. in Biology, Microbiology, Biochemistry, or Chemistry
Additional Preferences:
* Prior leadership experience in GMP QC laboratories supporting pharmaceuticals.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyQC Microbiology Scientist
Quality control analyst job in Indianapolis, IN
Job Description
We at ELIQUENT are looking for an experienced QC Microbiology Scientist to immediately join our ELIQUENT Engineering team. The QC Microbiology Scientist manages the activities of a dosage pharmaceutical quality control unit in the performance and analysis under GMP conditions for the entire site. Scope of responsibility includes raw material, in-process and finished goods testing and release as well as stability requirements for finished packaged goods. It also includes Environmental Monitoring of controlled environments to assure controlled environments are maintained.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Perform microbiology testing in the laboratory as specified by current procedures.
• Write specifications, sampling instructions, test methods, procedures and other QC procedures.
• Monitor any contract testing laboratory for compliance and test results.
• Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.
• Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.
• Coach other team members as required by QC or QA management.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Exhibit accountability and responsibility for an area or process to affect change and lead efforts and ideas to completion.
• Lead and/or support all investigations. Review and approve area quality and safety exceptions and investigation reports. Ensure on-time completion of investigations and corrective action items assigned to area.
• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
• Supply the highest level of customer service while having the ability to challenge established procedures and systems.
• Participate in and possibly lead continuous improvement activities.
• Ensure proper maintenance and cleanliness of the department, premises and equipment.
• Maintain an acceptable level of 5S in the area. Assure the laboratories are maintained to promote an organized workspace.
• Report laboratory incidents in a timely manner per site procedures and assist in any investigation processes.
• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
• Identify opportunities to reduce risk, reduce cost of poor quality and improve service.
QUALIFICATIONS AND REQUIREMENTS:
• Bachelor's Degree in scientific discipline required or equivalent work experience.
• 3 or more years microbiology experience.
• Strong knowledge of cGMP requirements.
• Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.
• Preferred expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.
• Preferred to have working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing guidelines.
• Preferred ability to use relevant software packages to process and analyze data.
• Preferred experience in equipment/instrument validation/qualification, change control, and investigations.
What We Offer:
Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
Microbiology Analyst 2
Quality control analyst job in Indianapolis, IN
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
You will help ensure our manufacturing areas are meeting all pharmaceutical standards, including our aseptic environment. You will assist with collecting samples on critical utilities such as nitrogen, process air and the sites' water systems. You will help with performing media fills including qualification and release in support of the environmental monitoring program. You will help with maintaining equipment and adhering to the sites Environmental Health and Safety program. You will assist with routine lab-related tasks and ensuring your work area is tidy to support audit readiness and bring issues to supervision immediately for escalations. You will also support QC in-process testing as a backup for weekend work.
Shift: Thursday - Sunday 7am - 5:30pm
Who You Are:
Minimum Qualifications:
* High School Diploma or GED.
* 1+ years of experience with biology or sterile pharmaceutical manufacturing.
Preferred Qualifications:
* Bachelor's Degree in Biology, Immunology, Biochemistry or other Science or Medical discipline.
Pay Range for this position: $24 - $38 / hour
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Quality Control Core 1/ Environmental Monitoring
Quality control analyst job in Indianapolis, IN
Title: Environmental Monitoring Technician Temp to perm potential 6am/8am start time - 8 hours a day Monday-Friday 3 positions on first shift Aseptic Technique/comfortable in clean rooms entry level microbiologist water collection GDP willingness to learn
Background Qualifications:
High School diploma required as minimum. Associates degree and/or related certification in Microbiological Sciences highly preferred.
Experience with aseptic technique and/or working in aseptic environments.
Ability to gown aseptically for Manufacturing and Aseptic Filling areas.
As persons in this role are engaged in sampling and environmental monitoring during open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
Working hours will require flexibility with available work hours.
Sufficient mobility to work in manufacturing processing areas is required.
Major Position Activities & Responsibilities:
Environmental monitoring of the aseptic area during production fills or weekly monitoring
Must immediately notify supervisor if affected by infectious disease or open lesions on body, as individuals are not permitted to enter manufacturing areas or handle product if these conditions exist.
Water collection and testing of WFI, Clean Steam, and the Deionized Water
Performs media fill qualification and release in support of environmental monitoring program.
Perform sampling activities in support of environmental investigations
Maintenance of the cleanliness of the microbiology laboratory area, refrigerators, and incubators
Handling of wastes including hazardous wastes. Attendance at mandatory annual hazardous waste training meeting(s). Demonstration of competency in training by passing test(s) administered by the company or consultant providing such training.
Responsible for adhering to the Environmental, Health and Safety program.
Performs special projects and other duties as assigned.
As a part of the employees job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
Senior QC Microbiologist
Quality control analyst job in Fishers, IN
The Quality Control Senior Microbiologist will work closely with the full Quality Control team, Quality Assurance and Manufacturing to develop and execute the microbiological testing of a wide variety of materials critical to and inclusive of the parenteral drug product manufacturing process. Such testing includes, but is not limited to: Bioburden, Endotoxin, Sterility, Hold-Time Studies, Hypothesis Testing, and Environmental/Utilities Monitoring.
The Senior Microbiologist will be committed to operating with a Quality Mindset in every aspect of their role, including attention to detail, on time delivery, and efficiency. They will generate, participate in, SME for, and review process critical Quality Events (Laboratory Investigations, CAPAs, Deviations, Continuous Improvements etc.).
The Quality Control Senior Microbiologist will demonstrate an ability to define problems, propose solutions, collect data, establish facts, and draw valid conclusions. It is critical to have excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Senior Microbiologist will exemplify excellent interpersonal skills and be capable of developing productive cross-functional relationships within the company. They will thrive in a dynamic, fast paced team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the Microbiologist will possess a demonstrated ability to influence positive outcome within the QC Microbiology team and take ownership of processes/systems.
Essential Job Functions:
Participate as a key player in establishing and improving the QC Microbiology Laboratory team.
Perform and improve testing including, at a minimum, sterility, endotoxin, and bioburden. Testing will be performed on Drug Products (API, BDP, FIP, and AI), excipients, and in-process materials.
Develop, improve, and participate in a robust Environmental and Utilities Monitoring program.
Hold self and others accountable for rigorous scientific and quality work standards.
Perform microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Generate, review, own, and complete Quality Events efficiently and to a high degree of accuracy. Interpersonal Focus
Train fellow QC personnel on instruments, processes, and assays when cross-training or new employee training is needed. Assist in the professional support and development of QC Microbiology Technicians within the QC lab.
Be team oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed.
Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by co-workers for accuracy and alignment with procedures.
Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured and released.
View constructive criticism and critiques to work and documentation as opportunities to improve themselves and the quality of the department; can also give feedback in a constructive manner.
Special Job Requirements:
B.S. in Science (Biology, Microbiology, Biochemistry etc)
3+ experience with microbiological testing.
High proficiency level in performing bioburden, endotoxin and sterility testing. Ability to evaluate, troubleshoot, and investigate testing results as they apply to the pharmaceutical process.
Possesses an excellent working knowledge of regulatory guidance (FDA, EP, JP etc).
Exceptional computer skills and data management both digital and manual.
Additional Preferences:
Advanced microbiology specific degree.
4+ years of experience in GMP biopharma industry in an aseptic drug product QC laboratory role.
Experience with Kaizen, Six Sigma, and/or Lean principles.
Experience in an isolator-based aseptic drug product manufacturing facility.
Project Management experience
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyQuality Control Inspector
Quality control analyst job in Anderson, IN
Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.
Position Summary:
The Quality Control Inspector is responsible for verifying product quality, conducting inspections and tests, and documenting results to ensure compliance with internal and external requirements. This role actively participates in problem-solving, root cause analysis, and continuous improvement efforts across the organization.
Role Responsibilities:
Perform inspections and testing of products to ensure compliance with specifications and quality standards.
Read and interpret blueprints, engineering drawings, and bills of materials.
Document inspection results, including Certificates of Conformance and other quality records.
Investigate customer complaints and product returns, and implement containment measures.
Participate in root cause analysis and develop corrective and preventive actions.
Calibrate and maintain standard measuring equipment (gauges, calipers, tooling).
Support the Production Part Approval Process (PPAP) and ISO 9001 requirements.
Resolve nonconforming material using company resources and procedures.
Collaborate with production, engineering, and management to drive continuous improvement.
Adhere to all EHS and PPE policies while maintaining a safe and positive work environment.
Minimum Qualifications:
High school diploma or GED with at least 1 year of quality control experience.
Knowledge of ISO 9001 or similar quality standards and quality techniques (e.g., SPC, PPAP).
Strong communication skills and proficiency with Microsoft Office.
Ability to work independently and in a fast-paced, team-oriented environment, including off-shifts or extended hours as needed.
Preferred Qualifications:
Associate's degree or technical certification in quality, manufacturing, or related field.
2+ years of quality control experience in a manufacturing environment.
Experience with ISO 9001 audits, SPC, PPAP, and root cause analysis.
Proficient with dimensional measurement tools, calibration, and interpreting blueprints.
Strong problem-solving skills with ability to support continuous improvement in a fast-paced environment.
Immigration Sponsorship Not Available:
· Donaldson will not offer immigration sponsorship or assume sponsorship of an employment visa for this position.
· International relocation or remote work arrangements outside of the U.S. will not be considered.
Keywords: Quality Assurance, Inspection, ISO9001
Equal Opportunity Employer, including Disability and Veterans
Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.
Donaldson Company has been made aware that there are several recruiting scams that are targeting job seekers. These scams have attempted to solicit money for job applications and/or collect confidential information, Donaldson will never solicit money during the application or recruiting process. Donaldson only accepts online applications through our Careers | Donaldson Company, Inc. website and any communication from a Donaldson recruiter would be sent using a donaldson.com email address. If you have any questions about the legitimacy of an employment opportunity, please reach out to ******************************* to verify that the communication is from Donaldson.
Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
Auto-ApplyAnalytical Lab Technician
Quality control analyst job in Shelbyville, IN
Knauf Insulation North America is the world's fastest-growing insulation manufacturer. We are wholly committed to the conservation of the environment while also sustainably developing and manufacturing a comprehensive line of acoustical fiberglass insulation for residential, commercial, industrial, marine, OEM and metal building applications, using post-consumer recycled materials.
We welcome passionate and creative individuals who thrive in an entrepreneurial, collaborative and ever-changing environment.
We know how important your health, wellbeing, and financial strength is to you. To support you, we provide affordable benefits for you and your family members.
"Supporting all aspects of the individual - self, health, wealth and community”
Our benefits include:
Offsite free clinic
Medical, Dental, Vision - starting on day one!
Virtual Medical Services
401(k) Retirement Plan (earn 100% matching on your first 6% and fully vested day one)
Paid parental leave
Company paid life insurance
Vacation time to enjoy getting away
Tuition Reimbursement
Employee Assistance Program (EAP)
Plus, more!
Growth opportunities available!
Apply online or contact us to hear why our employees appreciate being part of the Knauf family!
About the Role:
We are seeking a detail-oriented and motivated Analytical Lab Technician to join our team. In this role, you will be responsible for conducting laboratory tests on raw materials, certifying finished products, and performing requested laboratory analyses. You will also ensure the proper maintenance and cleaning of laboratory instruments while adhering to all company safety requirements and policies. This position plays a critical role in supporting our commitment to quality, innovation, and employee engagement.
Responsibilities
Perform laboratory analysis on a variety of materials, including batch raw materials, glass, chemicals, and glass mineral wool final products.
Conduct tests to certify finished products and ensure compliance with quality standards.
Analyze data and prepare detailed technical reports to support decision-making processes.
Maintain and clean laboratory instruments to ensure optimal performance and accuracy.
Follow and actively participate in all company safety requirements, policies, and related documentation.
Assist Innovation team members with laboratory testing and other tasks as requested.
Leadership and Culture:
Drives the highest levels of employee retention and engagement to ensure a sustainable and motivated workforce.
Foster a culture of innovation, collaboration, and accountability within the organization.
Promote an environment of inclusion, ensuring all employees feel valued and empowered to contribute positively to the company.
Qualifications
Education:
Bachelor's or Associate's degree in Chemistry, Geology, Environment Science, Engineering or similar field
Experience:
Analytical and/or Inorganic lab experience, preferred
Knowledge, Skills, and Abilities:
Proficient in Microsoft Excel and/or other data analysis software.
Knowledge of X-Ray Fluorescence (XRF), preferred.
Strong analytical and problem-solving skills.
Experience in laboratory testing and data analysis.
Familiarity with laboratory instruments and their maintenance.
Commitment to safety and adherence to company policies.
Excellent communication and teamwork abilities.
Why Join Us?
At Knauf, we are committed to fostering a workplace that values innovation, collaboration, and inclusion. As an Analytical Lab Technician, you will have the opportunity to contribute to our mission of delivering high-quality products while working in an environment that supports your professional growth and development.
It is the policy of Knauf Insulation to provide equal employment opportunities to all qualified persons without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status or any other protected characteristic prohibited by applicable law.
Auto-ApplyQC Biochemist - Night Shift
Quality control analyst job in Indianapolis, IN
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Perform wet chemistry testing
HPLC, UV-Vis, CE
Sample receipt
Glassware washing
Use ALCOA to document test results in electronic notebooks
Would support various QC labs where work is needed
Qualifications
Bachelor's degree in physical science (chemistry, physics, etc.), or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
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 with internal and external clients, 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
Proficiency in IT related skills such as Microsoft excel, Word, PowerPoint etc
Authorization to work in the United States indefinitely without restriction or sponsorship
Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply
Additional Information
Position is full-time, nights 6pm to 4am, Wed to Sat (4x10s shift)
Candidates currently living within a commutable distance of Indianapolis, IN 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
#LI-EB1
Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Chemistry Lab Technician
Quality control analyst job in Indianapolis, IN
We are seeking a self-motivated Chemistry Lab Technician to join our Lab Operations team. In this role you will assist in laboratory confirmatory analysis of biological fluids including urine, oral fluid (saliva) or hair specimens. This role is also responsible for operating, maintaining and troubleshooting various Auto Chemistry instrumentation.
Shift: 03:00 - 11:30pm
Salary: $20.00 per hour
Primary Responsibilities
Loads, prepares and extracts specimens using various Auto-Chem Instrumentation.
Assist in instrument calibration, QC review, and initial analytical review.
Prepare reagents and buffers as needed.
Assists with maintaining an adequate inventory of laboratory supplies.
Responsible for all record keeping associated with specimen preparation, including following chain of custody handling guidelines and storage requirements.
Conducts safe work practices according to safety protocols, PPE requirements and decontamination procedures.
Responsible to maintain all safeguards as it pertains to Protected health information (PHI).
Qualifications
Bachelor's degree in a science field (Chemistry, Biochemistry, Biology, Microbiology, Pre-med (Biomed), required.
Experience as a lab technician, preferred utilizing LCMS equipment.
Data entry skills via a keyboard (alpha and numeric) required.
Strong eye-hand coordination.
Ability to handle a high-volume environment while maintaining the highest level of quality, required.
Physical demands required to perform critical tasks in this role include standing for long periods of time, lifting up to 25lbs, bending and carrying.
Benefits
Cordant supports our employees by providing a comprehensive benefits package to eligible staff (per state regulations) that includes: Medical, Dental, Vision Insurance, Flexible Spending Accounts (FSA), Health Savings Accounts (HSA) Paid Time Off (PTO) accruing on day 1, Volunteer Time Off (VTO), Paid Holidays, 401(k) with Company Match, Employee Assistance Program (EAP), Short Term and Long-Term Disability (STD/LTD) and Company Paid Basic Life Insurance. #LAB123
Quality Control Chemist
Quality control analyst job in Indianapolis, IN
The QC Chemist will support all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulations, procedures, and product specifications.
Key Responsibilities:
Compendia experience (USP, EP, BP, JP, CP).
Finished Product testing, Environmental Monitoring, Sterility QC testing, and reporting of the QC results.
Escalation in case of non-conformances and deviations, and manage these quality incidents as per procedures.
Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow-up and implementation, and Change Control management, including procedure and form revisions.
Participation in assigned qualification/validation activities, as necessary.
Responsible for the successful on-time completion of required training curricula comprising the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training, including HSE for the specific role.
Prepares applicable documents, forms, and records such as analytical batch records, and follows Good Documentation Practices. Support internal and external Audits and Inspections, as required.
Essential Requirements:
Education: Bachelor's degree required in a relevant Scientific discipline (e.g, Chemistry, Microbiology).
A minimum of 2-3 years of experience in a cGMP or aseptic environment is required. Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques.
Practical experience with Microbiology method verification and routine testing practices, EM Monitoring, and basic knowledge of method/equipment validation principles and methodologies preferred; HPLC knowledge is required.
Ability to interpret analytical data and convert it into technical documentation.
Basic knowledge and understanding of aseptic principles and techniques, Quality Control Sampling, Quality Control (QC Testing), and General HSE knowledge.
INCOG BioPharma Services Careers - QC Microbiology Method Transfer Scientist
Quality control analyst job in Fishers, IN
INCOG BioPharma Services is looking for a Microbiology Method Transfer Scientist who will be dedicated to producing the highest quality products for our clients. This role will be a key member of the INCOG Quality Control laboratory team who has a passion for learning, collaborating, and contributing to the success of our clients. The Microbiology Method Transfer Scientist will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for our clients.
The Microbiology Method Transfer Scientist will work closely with Quality Control leadership and will develop and lead the program for performing method transfer for analytical and/or microbiological assays from client laboratories into the INCOG QC Laboratories. The Microbiology Method Transfer Scientist will be committed to operating with a Quality Mindset in every aspect of their role, including attention to detail, on time delivery, and efficiency.
This role may require flexibility to work outside of core business hours. (ie. early mornings or later evenings depending on business needs.)
Essential Job Functions:
* Test out, redefine and develop new (where necessary) the INCOG QC Method Transfer program for both analytical and microbiological assays.
* Perform assessments of both incoming client methods and compendial test methods for raw materials, container/closures, API/BDS, in-process, and finished products for suitability with existing INCOG laboratory capabilities to identify if additional chemicals or instruments are required.
* Partner with customers to develop, review, approve, and execute method transfer into the chemistry and/or microbiology laboratory.
* Collaborate with the Quality Team on building laboratory safety program to ensure a safe and quality-minded environment for all personnel working in the laboratory.
* Holds self and others accountable for rigorous scientific and quality work standards.
* Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
* Maintain a constant state of safety and inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
* Support laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
* Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Special Job Requirements:
* Be available to participate in lab activities and client meetings that may go outside of standard business hours (Monday-Friday 8 AM-5 PM).
* Use applied statistics to analyze and track test results to identify sources of variability and error in laboratory and manufacturing processes.
* Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
* Maintain regulatory intelligence on the regulatory landscape, policies, and pharmaceutical industry trends through continuous education, networking, literature, trade organizations, etc.
* Be available to support routine QC testing for raw materials, API/BDS, container/closures, in-process, finished products, and environmental monitoring as needed, even on alternate shifts.
* 5+ years of microbiology and other related experience in GMP manufacturing/GMP QC testing of pharmaceuticals.
* Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, particularly related method development and method transfer.
* Experience with using laboratory instrumentation.
* Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.).
* B.S./B.A. in Biology, Microbiology or Biochemistry.
Additional Preferences:
* Prior leadership experience in GMP QC laboratories supporting pharmaceuticals.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyQC Analytical Method Development Scientist
Quality control analyst job in Indianapolis, IN
Job Description
We at ELIQUENT are looking for an experienced QC Analytical Method Development Scientist to immediately join our ELIQUENT Engineering team. The Analytical Method Development Scientist supports pharmaceutical product development by designing, developing, optimizing, and validating analytical methods used for characterization, in-process control, release testing, and stability studies. This role ensures all analytical work complies with GMP/GLP requirements and ICH guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develop and optimize analytical methods for small-molecule drug substances, drug products, excipients, and in-process samples.
• Utilize pharma-relevant techniques such as HPLC/UPLC, GC, LC-MS, dissolution testing, UV-Vis, FTIR, and compendial methods.
• Assess method performance (e.g., selectivity, sensitivity, linearity, robustness) and generate scientifically sound rationale for method conditions.
• Troubleshoot analytical methods and instrumentation issues to ensure reliable performance in a GMP setting.
• Design and execute validation protocols with any of the following 21 CFR Part 212, USP /, ICH Q2(R2), and FDA guidance.
• Prepare method validation reports, risk assessments, and technical justifications.
• Perform statistical analysis of method performance using pharma-appropriate tools.
• Maintain accurate and compliant GMP documentation consistent with ALCOA+ principles.
• Assist with the development of method SOPs.
• Participate in project teams to ensure analytical readiness for clinical and commercial production.
• Participate in failure investigations, root cause analyses, and CAPA activities involving analytical methods or results.
QUALIFICATIONS AND REQUIREMENTS:
• Bachelor's in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• 3-7+ years of experience in pharmaceutical analytical development, method validation, or QC in a GMP-regulated environment.
• Experience supporting PET/SPECT radiotracers, sterile injectables, or radioactive drug products is preferred but not required.
• Strong hands-on experience with HPLC/UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution, and compendial methods.
• Knowledge of 21 CFR Part 212, 21 CFR Part 211, USP, and ICH guidelines
• Familiarity with Empower and GMP documentation systems.
• Strong analytical problem-solving skills.
• Excellent technical writing and communication abilities.
• Ability to manage multiple development projects and work independently in a fast-paced pharma environment.
WORK ENVIRONMENT:
• Primarily laboratory-based with routine use of analytical instrumentation.
• Requires adherence to GMP, safety procedures, and PPE requirements.
• Occasional flexibility needed to support project deadlines and analytical troubleshooting
What We Offer:
Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
Quality Control Core 1
Quality control analyst job in Indianapolis, IN
Title: Environmental Monitoring Technician Temp to perm potential 10am/12pm start time - 8 hours a day Monday-Friday Shift differential: 7% 3 positions on first shift Aseptic Technique/comfortable in clean rooms entry level microbiologist water collection
GDP
willingness to learn
Background Qualifications:
High School diploma required as minimum. Associates degree and/or related certification in Microbiological Sciences highly preferred.
Experience with aseptic technique and/or working in aseptic environments.
Ability to gown aseptically for Manufacturing and Aseptic Filling areas.
As persons in this role are engaged in sampling and environmental monitoring during open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
Working hours will require flexibility with available work hours.
Sufficient mobility to work in manufacturing processing areas is required.
Major Position Activities & Responsibilities:
Environmental monitoring of the aseptic area during production fills or weekly monitoring
Must immediately notify supervisor if affected by infectious disease or open lesions on body, as individuals are not permitted to enter manufacturing areas or handle product if these conditions exist.
Water collection and testing of WFI, Clean Steam, and the Deionized Water
Performs media fill qualification and release in support of environmental monitoring program.
Perform sampling activities in support of environmental investigations
Maintenance of the cleanliness of the microbiology laboratory area, refrigerators, and incubators
Handling of wastes including hazardous wastes. Attendance at mandatory annual hazardous waste training meeting(s). Demonstration of competency in training by passing test(s) administered by the company or consultant providing such training.
Responsible for adhering to the Environmental, Health and Safety program.
Performs special projects and other duties as assigned.
As a part of the employees job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
Analytical Lab Technician
Quality control analyst job in Shelbyville, IN
Knauf Insulation North America is the world's fastest-growing insulation manufacturer. We are wholly committed to the conservation of the environment while also sustainably developing and manufacturing a comprehensive line of acoustical fiberglass insulation for residential, commercial, industrial, marine, OEM and metal building applications, using post-consumer recycled materials.
We welcome passionate and creative individuals who thrive in an entrepreneurial, collaborative and ever-changing environment.
We know how important your health, wellbeing, and financial strength is to you. To support you, we provide affordable benefits for you and your family members.
"Supporting all aspects of the individual - self, health, wealth and community”
Our benefits include:
Offsite free clinic
Medical, Dental, Vision - starting on day one!
Virtual Medical Services
401(k) Retirement Plan (earn 100% matching on your first 6% and fully vested day one)
Paid parental leave
Company paid life insurance
Vacation time to enjoy getting away
Tuition Reimbursement
Employee Assistance Program (EAP)
Plus, more!
Growth opportunities available!
Apply online or contact us to hear why our employees appreciate being part of the Knauf family!
About the Role:
We are seeking a detail-oriented and motivated Analytical Lab Technician to join our team. In this role, you will be responsible for conducting laboratory tests on raw materials, certifying finished products, and performing requested laboratory analyses. You will also ensure the proper maintenance and cleaning of laboratory instruments while adhering to all company safety requirements and policies. This position plays a critical role in supporting our commitment to quality, innovation, and employee engagement.
Responsibilities
Perform laboratory analysis on a variety of materials, including batch raw materials, glass, chemicals, and glass mineral wool final products.
Conduct tests to certify finished products and ensure compliance with quality standards.
Analyze data and prepare detailed technical reports to support decision-making processes.
Maintain and clean laboratory instruments to ensure optimal performance and accuracy.
Follow and actively participate in all company safety requirements, policies, and related documentation.
Assist Innovation team members with laboratory testing and other tasks as requested.
Leadership and Culture:
Drives the highest levels of employee retention and engagement to ensure a sustainable and motivated workforce.
Foster a culture of innovation, collaboration, and accountability within the organization.
Promote an environment of inclusion, ensuring all employees feel valued and empowered to contribute positively to the company.
Qualifications
Education:
Bachelor's or Associate's degree in Chemistry, Geology, Environment Science, Engineering or similar field
Experience:
Analytical and/or Inorganic lab experience, preferred
Knowledge, Skills, and Abilities:
Proficient in Microsoft Excel and/or other data analysis software.
Knowledge of X-Ray Fluorescence (XRF), preferred.
Strong analytical and problem-solving skills.
Experience in laboratory testing and data analysis.
Familiarity with laboratory instruments and their maintenance.
Commitment to safety and adherence to company policies.
Excellent communication and teamwork abilities.
Why Join Us?
At Knauf, we are committed to fostering a workplace that values innovation, collaboration, and inclusion. As an Analytical Lab Technician, you will have the opportunity to contribute to our mission of delivering high-quality products while working in an environment that supports your professional growth and development.
It is the policy of Knauf Insulation to provide equal employment opportunities to all qualified persons without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status or any other protected characteristic prohibited by applicable law.
Not ready to apply? Connect with us for general consideration.
Auto-ApplyQC Chemist - 12 Hour Night Shift
Quality control analyst job in Indianapolis, IN
🔬 Grow Your Scientific Career with Purpose at Eurofins PSS Insourcing Solutions
At Eurofins PSS, the work we do matters-from ensuring the safety of medicines to protecting the environment-and so do our employees. If you're looking to advance your career and make a meaningful impact, we offer a place to learn, lead, and thrive.
We believe in investing in your potential. Whether you're looking to deepen your expertise, take on new challenges, or expand your leadership skills, Eurofins provides the tools, support, and collaborative environment to help you grow.
🌟 Why Join Eurofins?
Career Development: Opportunities to expand your skillset and take on leadership roles
Supportive Teams: A culture that values collaboration, innovation, and continuous improvement
Work-Life Balance: Flexible schedules and a competitive benefits package
Industry Impact: Work alongside global leaders in the biopharmaceutical space
🌍 Who We Are
Eurofins Scientific is a global life sciences company offering a unique range of analytical testing services across industries. From the food you eat to the medicines you rely on, we help ensure safety, authenticity, and quality. We're proud to be a leader in pharmaceutical, environmental, food, cosmetics, and genomics testing.
💼 Ready to Take the Next Step?
If you're ready to grow your career in a mission-driven organization that values your contributions, apply today and discover what's possible at Eurofins.
Job Description
🔬 Key Responsibilities
Biochemical Testing
Perform analytical testing on proteins and antibodies using techniques such as:
Capillary Electrophoresis (CE)
Ion Chromatography (IC)
HPLC, SEC, SDS-PAGE
UV Spectroscopy
Protein A Titer
ELISA
Particulate Analysis
Lab Operations
Work as part of a rotating day shift team (3-2-2-3 schedule), including weekends and holidays
Enter and manage data in LIMS; experience with Empower is a plus
Document results in lab notebooks and formal reports
Compliance & Collaboration
Operate independently and collaboratively in a GMP-regulated environment
Participate in investigations and support continuous improvement initiatives
Qualifications
🎓 Qualifications
Education:
Bachelor's degree in biology, biochemistry, chemistry, or a related scientific field
Technical Skills:
Experience with one or more of the following is strongly preferred:
HPLC
Capillary Electrophoresis (CE)
Ion Chromatography (IC)
SDS-PAGE
ELISA
Work Authorization:
Must be authorized to work in the United States indefinitely without restriction or sponsorship
Additional Information
Training will take place on day shift, Monday-Friday 8AM-5PM, for roughly 3 months.
After the training period, the shift will be on a 3,2,2,3 rotation from 6PM-6AM.
Candidates currently living within a commutable distance of Indianapolis, IN 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
#LI-EB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
INCOG BioPharma Services Careers - QC Chemist, 3rd Shift
Quality control analyst job in Fishers, IN
INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the integrity of data generated for clients. The QC Chemist will work closely with the QC Chemistry Manager and Quality Control Method Transfer Scientists, as well as Project Management and Supply Chain teams, to support development, readiness, and routine testing activities for the Quality Control Chemistry laboratory.
This role is crucial in generating ALCOA+ data and upholding our Quality Mindset through attention to detail, on-time delivery, and commitment to Quality excellence. Strict adherence to Good Documentation Practices (GDP) is required as Good Manufacturing Practice (GMP) testing is performed.
Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The QC Chemist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The QC Chemist will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.
Essential Job Functions:
* Perform routine and batch-related testing on incoming components, raw materials, in-process samples, finished product, and stability samples according to validated methods as well as special testing deemed necessary by protocols
* Assist in sampling and testing of incoming materials requiring QC testing as needed
* Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes
* Participate in the completion of laboratory investigations/deviations and provide SME support where needed
* Perform basic troubleshooting activities with respect to methods/assays, equipment malfunctions, and investigations (Deviations and OOS)
* Execute routine laboratory work orders for maintenance and non-critical calibrations
* Perform minor preventative maintenance on QC laboratory instrumentation as needed using written SOPs or assist vendors with access to systems/materials when vendor performs maintenance
* Execute day-to-day tasks within the laboratory including sample inventory disposition/disposal, consumables ordering/inventory, preparing instruments for testing, and laboratory waste management
* Assist in the control and management of laboratory waste in cooperation with relevant EH&S standards
* Assist in the development and execution of protocols for method transfers, method validations, stability studies, cleaning validations, and any other special testing required from the Quality Control Chemistry laboratory
* Support internal and external customers to ensure proper and timely execution of all aspects of the clinical/commercial analytical method life cycle across clients
* Conduct periodic reviews of analytical test procedures and SOPs as required
* Review and approve analytical testing procedures and protocols as needed
* Assist in training fellow QC and Development personnel on instruments and assays when cross-training is needed
* Assist in the professional support and development of QC Chemistry Technician staff within the QC laboratory
* Be team-oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed
* Set deadlines and prioritize work for self, group members, and support groups involved
* Review/approve work performed by coworkers for accuracy and alignment with procedures
* Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured, and released
* Identify, evaluate, and implement continuous business process improvements
Special Job Requirements:
* This position will support primarily third shift (11:00pm-7:30am)
* Bachelor's Degree in Science (Chemistry or Biochemistry)
* Minimum of 3+ years of biopharma industry experience, with at least 2 years of hands-on experience in a GMP environment/Quality Control testing in a regulated environment or other related experience
* High proficiency level in operating UHPLC/HPLC, GC, SoloVPE, UV-VIS, TOC, particulate matter analyses, method validation/transfer, and relevant laboratory computer systems with associated data integrity requirements
* Excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control
* Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.)
Additional Preferences:
* Experience with Continuous Improvement, Six Sigma, and/or Lean principles
* Experience with building processes and procedures
* Experience in performing testing and/or characterization of biologic (monoclonal antibody, enzyme) and small molecule (peptide, mRNA) products
* Experience performing container closure integrity testing (CCIT)
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyQC Biochemist - Night Shift
Quality control analyst job in Indianapolis, IN
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Perform wet chemistry testing
HPLC, UV-Vis, CE
Sample receipt
Glassware washing
Use ALCOA to document test results in electronic notebooks
Would support various QC labs where work is needed
Qualifications
Bachelor's degree in physical science (chemistry, physics, etc.), or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
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 with internal and external clients, 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
Proficiency in IT related skills such as Microsoft excel, Word, PowerPoint etc
Authorization to work in the United States indefinitely without restriction or sponsorship
Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply
Additional Information
Position is full-time, nights 6pm to 4am, Wed to Sat (4x10s shift)
Candidates currently living within a commutable distance of Indianapolis, IN 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
#LI-EB1
Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.