- Insight Global (Malvern, PA)
- …team of 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor. Key Responsibilities: ... qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing...out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr.… more
- Boehringer Ingelheim (Barceloneta, PR)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Manger, Quality Control will manage and provide direction within the ... Quality Control Laboratory and Incoming Samples areas. The position holder...topics. + Revises, provides impact assessments and approves Change Control documents as QC SME. + Prepares… more
- WuXi AppTec (Middletown, DE)
- **Overview** Job Summary: We are seeking an accomplished and strategic Quality Control ( QC ) leader to establish and oversee all QC operations for WuXi ... site. The QC Director will lead all Quality Control functions for WuXi STA's new...maintaining GMP-compliant laboratory operations to support the release and stability testing of drug products, raw materials, and packaging… more
- BeOne Medicines (Pennington, NJ)
- …+ Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + Familiar with instrument and equipment ... Biochemistry GMP laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to...validation. + Expert knowledge of quality control principles, practices, and standards for… more
- ThermoFisher Scientific (Boston, MA)
- …Good Manufacturing Practices (GMP) Safety Standards **Job Description** **Senior Scientist - QC Stability Data Review** Shift: Full-Time; Monday - Friday; ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- System One (Pennington, NJ)
- …or the equivalent.nd/or CDMO experience strongly preferred Full Scope of Responsibilities + Quality Control Oversight: Manage QC workflows to ensure ... Job Title: QC Compliance Manager - Biologics / Biosimilars Location:...compliance frameworks. + Work with advanced biologics platforms and global- quality operations. + Thrive in a dynamic, startup-like environment… more
- WuXi AppTec (Middletown, DE)
- …during both startup and steady-state operations, supporting Analytical and Microbiology QC teams. **Responsibilities** Stability Sample Management and Laboratory ... to GMP standards. * Foster a culture of efficiency, quality , and continuous improvement within the QC ...readiness. * Contribute to investigations, CAPA implementation, and change control related to QC operations. * Proactively… more
- BeOne Medicines (Pennington, NJ)
- …laboratory test results, ensuring adherence to Good Documentation Practices. + Expertise in Quality Control ( QC ) within a Good Manufacturing Practice (GMP) ... required. + Ensure timely completion of testing (eg, In-process control , DS release, DP release, and stability ...with instrument and equipment validation. + Expert knowledge of quality control principles, practices and standards for… more
- WuXi AppTec (Middletown, DE)
- **Overview** The QC Analytical Lead is responsible for establishing and managing all analytical operations for the QC function at WuXi STA's new drug product ... of GMP-compliant systems for testing drug products, raw materials, and components. The QC Analytical Lead will ensure timely and accurate execution of release and … more
- BeOne Medicines (Pennington, NJ)
- **General Description:** The Associate Director Quality Control ( QC ) will lead analytical strategy, method lifecycle management, and QC operations to ... the studies of the characterization of in-process, release, and stability samples in support of manufacturing operations ensuring compliance...**Essential Functions of the Job:** + Develop and oversee quality control ( QC ) procedures and… more
- PCI Pharma Services (Bedford, NH)
- …Sample Coordinator I **Location:** Bedford, New Hampshire **Department:** Quality Control / Incoming materials **Reporting To:** QC Supervisor, Sample ... position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material...Assist with coordinating external testing + Request and maintain Quality Control logbooks in accordance with cGMP… more
- WuXi AppTec (Middletown, DE)
- …and equipment qualification, as well as maintaining compliance with GMP, corporate quality standards, and global regulatory requirements. The QC Analytical ... **Overview** Reporting to the QC Analytical Lead, the QC Analytical...testing for drug products, raw materials, packaging components, and stability samples in accordance with approved methods and SOPs.… more
- Kelly Services (Princeton, NJ)
- ** QC Project Manager- BLA Filing- Princeton NJ** **General Description** The ideal candidate must have experience supporting regulatory submission readiness, with a ... strong focus on **tracking QC deliverables, testing schedules, and resource loading to ensure...submission. + Lead the establishment and maintenance of a ** stability program** , ensuring data availability for regulatory filing.… more
- WuXi AppTec (Middletown, DE)
- …sample handling, equipment operation, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Analyst will ... QC Microbiology Lead to ensure timely and accurate completion of QC tasks for product release, stability studies, and validation activities.… more
- Kelly Services (Princeton, NJ)
- …Hire- Princeton NJ The ** QC Chemistry Supervisor** will lead all Quality Control Chemistry laboratory operations to support GMP manufacturing, testing, and ... + Lead and manage the setup and operationalization of a new QC Chemistry laboratory. Conduct or supervise bench-level testing as needed. + Oversee… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …The QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control ( QC ) department. Key areas of focus are development and ... Job Title QC Analyst II - Chemistry Requisition JR000015537 QC ...implementation of the quality aspects of late stage or marketed product strategy. This role… more
- Cambrex High Point (High Point, NC)
- …in a GMP/ QC -compliant pharmaceutical laboratory environment) with focus on ICH stability testing. + Strong Quality Control , compliance, scheduling, and ... patients around the world. Job Overview Come join our QC team of experts. This role will m anage...of experts. This role will m anage and direct Quality Control scientific staff. Focus efforts of… more
- ENFRA (Long Beach, MS)
- …this role encompasses overseeing and managing all aspects of the operations quality control and assurance processes. This position typically involves strategic ... Scheduling contract NDE as needed * Regulatory Compliance: Ensuring that all quality control activities comply with relevant regulatory requirements, standards… more
- WuXi AppTec (Middletown, DE)
- **Overview** The QC Microbiology Lead will manage all microbiology laboratory activities at WuXi STA's drug product manufacturing site in Middletown, DE. This role ... monitoring (EM), water system monitoring, bioburden, endotoxin, and identification testing. The QC Microbiology Lead will play a key role in site startup by… more
- Kelly Services (Philadelphia, PA)
- …II, Biologics (full benefits) **Location:** Bristol, Pennsylvania 19007 **Job Summary** The ** Quality Control ( QC ) Associate II** is responsible for ... and non-routine testing of raw materials, in-process samples, final product, and stability samples in support of **GMP manufacturing** . **Key Responsibilities** +… more
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