25 qc analyst jobs found

As a QC Analyst you will perform a wide variety of analytical chemistry testing to support in-process and bulk drug substance manufacture in a cGMP regulatory environment. . T he successful candidate will be required to work shift which includes days & nights. A typical day might include, but is not limited to, the following:   Gathering data and documenting test results Reviewing test results to ensure compliance with standards; reports any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting testing on raw materials, in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups Owning the...

Within this role you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.     As a QC Analyst within the Bioassay Lab, a typical day might include, but is not limited to, the following:   Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs) Reviewing data from other analysts for accuracy and completeness Performing bioassays in compliance with cGMP practices Sub-culturing mammalian cell lines and performing cell counts Maintaining laboratory reagents and supplies Preparing reagent aliquots and media for use in cell-based assays Maintaining equipment in the laboratory Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT Initiating and completing CAPAs in accordance with site...

As a QC Analyst you will perform a variety of chemical or biological analyses on raw materials, products, in-process materials, or stability samples in support of the company’s quality program. T he successful candidate will be required to work shift which includes days & nights. A typical day might include, but is not limited to, the following:   Gathering data and documents test results Reviewing test results to ensure compliance with standards; reports any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting tests on raw materials, in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups...

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst with a 3rd shift, Wednesday-Sunday, 10pm-8:30am schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Microbiology Analysts perform microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will be primarily responsible for performing routine environmental monitoring for aseptic fill/finish manufacturing areas, utilities sampling and testing, , gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing. As a QC Micro Analyst, a typical day might include the following: Environmental monitoring of controlled environments, personnel and...

Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility.  Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.   Note, this is a shift based role (12/7 - extended days) As a QC Micro Analyst a typical day might include, but is not limited to, the following: Entering a laboratory cleanroom’s to collect and log samples for microbial analysis Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs) Performing sample analysis for microbial identification Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas Performing acceptance testing of commercially prepared microbiological culture media. Autoclaving microbiological media and laboratory waste as needed Ensuring that all work...

Regeneron is currently looking for a Quality Control (QC) Analyst for our QC Raw Material Utility laboratory with a 1st shift, Monday-Friday, 6am-2:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC raw material utility laboratory performs testing of the raw materials used in the manufacturing process. Various raw materials are tested in the laboratory using manual or instrumentation testing procedures.     As a QC Analyst, a typical day might include the following: • Train other employees on laboratory activities • Utility (water/gas) testing • Data review • Perform laboratory investigations • Write / revise laboratory related documentation (e.g. SOPs, SPECs) • Maintain laboratory supplies • Ensure continuous laboratory compliance to cGMP requirements (e.g. Laboratory cleanliness, equipment within calibration, proper...

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

Career Category Information Systems Job Description Role Description: In this vital role, you will be part of the  Quality Control (QC) Products Team , collaborating closely with business partners, product owners, analysts, developers, and testers to ensure that validation activities and strategies for IT systems are executed effectively and in compliance with organizational and regulatory requirements. This position plays a key role in driving  compliance, efficiency, and innovation  in the management of data validation processes that support the QC product lifecycle. You will help advance  continuous improvement and automation initiatives  across the QC digital ecosystem, ensuring systems and tools are optimized to meet evolving quality standards. Roles & Responsibilities: Act as a liaison between Quality Control (QC), IT, vendors, and developers to capture, document, and translate business requirements into system solutions.   Support multiple QC digital...

Within this role you will be responsible for the configuration, implementation, maintenance, and ongoing support of Labware LIMS system.  As a Senior IT Applications Analyst within Quality Systems a typical day might include, but is not limited to, the following:  Administer, configure, and maintain Labware LIMS software to support laboratory operations Provide technical support to end-users, resolve system issues, and troubleshoot errors related to Labware LIMS and other lab systems. Collaborate with laboratory staff to understand their needs and translate them into Labware LIMS configurations. Lead and participate in LIMS-related projects, ensuring timely delivery and adherence to project goals. Coordinating across business departments and stakeholders, gathering, and implementing enhancement requests across departments  Acting as a Technical SME/Lead on initiatives   Managing system documentation tasks, including converting User Requirement Specifications to Detailed...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration....

Within this role you will be responsible to specialize in developing new QC microbiology test methods; providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. This is a 12-month temporary contract As a QC Micro Specialist, a typical day might include, but is not limited to, the following: Identifying, introducing, onboarding and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures, becoming the SMEs of these technologies, assays, and procedures Leading Test Method validations, studies and assisting in troubleshooting efforts (Investigations). These include test methods transferred or developed...

Within this role you will be responsible for tasks related to the support of manufacturing operations (Large Scale & Sub-Suites); primarily the tracking, collation , analysis and presentation of manufacturing operations data & metrics by liaising with all manufacturing functions and other departments to collate and track relevant data. As an Associate Manufacturing Operations Specialist, a typical day might include, but is not limited to, the following: Collating data/KPI metrics from multiple sources both internally & externally (including EHS, HR, QC Finance, QA) for manufacturing operations Compiling the data into charts, spreadsheets and scorecards or other as required Preparing presentations on the compiled data and presents this data; presents at relevant departmental meetings Responsible for the collation and upkeep of all trackers and spreadsheets in relation to headcount resources within manufacturing operations Participating in...

Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends. As a Sr QA Validation Specialist a typical day might include, but is not limited to, the following:   Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use that contribute to 365 inspection readiness program Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures Previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits Scheduling, executing, reviewing...

We are seeking a Senior Principal Scientist with a focus in Ophthalmology to join our Clinical Imaging team. You will conceptualize, support, execute, operationalize and optimize complex early- to late-phase ophthalmology clinical trials where imaging plays a central role. Work closely with Regeneron clinical, preclinical and external partners, with emphasis on delivery of high quality imaging data and development of innovative imaging-based biomarkers across ophthalmic modalities and indications. As a Senior Principal Scientist in Clinical Imaging, a typical day may include the following: Collaborate closely with Research colleagues in Ophthalmology to develop and qualify imaging biomarkers with a view toward clinical translation Collaborate with Regeneron clinical teams as imaging subject matter expert to ensure optimal design and execution of imaging biomarker strategy related to study endpoints, including development of protocols, imaging manuals, imaging charters...

As an integral part of a study, the statistical programmer provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: Assist in providing mentorship in implementing and driving the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Design and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment. Support and/or lead programmer for...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

A senior statistical programmer provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: The incumbent assists in providing guidance in implementing and executing the programming and project standards. The evaluation and development of study  requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of...

We are currently looking to fill a Quality Assurance Specialist (Batch Disposition) position. This position performs activities supporting dispositioning product while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Review of data in LIMS to perform QC CofA review Review and approval of QC Virology CofAs Represent disposition in support of onboarding new modalities and product forms Assess change controls in support of LAF creation Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in, and/or ownership of, investigations, evaluations, and problem resolution Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; collaborate closely with external partners and provide input on regulatory...

Within this role you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.  As a Senior QC Scientist a typical day might include, but is not limited to, the following:   Executing investigation testing (FT-IR, SEM, ICP-MS, SEM, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support Evaluating/interpreting data, author and review technical documents for investigational testing Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices Participating in routine maintenance and troubleshooting of laboratory instrumentation Liaising with contract laboratories as required to support investigational analysis Tabulating results and writing summary reports of assay development and validation studies Presenting findings at group...

As a QC Staff Scientist in Biochemistry you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development/validation and/or transfer. In this role a typical day might include, but is not limited to, the following: Participating in assay development/validation for QC Reviewing and approving new test procedures and assays Evaluating new methodologies, techniques and equipment when new procedures are warranted Participating in transfer of methodology from R&D Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed Evaluating assay performance through yearly method performance reports Facilitating assay transfer from R&D and to business partners Providing technical input into additional studies supporting regulatory filing e.g.. Bridging/comparability...