- Merck & Co. (Rahway, NJ)
- …capital projects, work to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off ... with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP , and data integrity regulations to ensure compliance with regulatory… more
- Merck & Co. (Durham, NC)
- …an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs , various other manufacturing buildings and Maintenance and Material Storage Facility ... shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdownsCoordinates with Site Engineering and IPT… more
- Merck & Co. (Durham, NC)
- …an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs , various other manufacturing buildings and Maintenance and Material Storage Facility ... to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns Coordinates with Site Engineering and… more
- ThermoFisher Scientific (Middleton, WI)
- …to accuracy and quality to deliver groundbreaking innovations! **Discover Impactful Work:** The Data Reviewer performs review of a variety of routine ... Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Title:** Data Reviewer **Details:** Fully remote, full time **Department:**… more
- Prime Matter Labs (Torrance, CA)
- …+ Analyzes compounds to determine chemical and physical properties. + Complete routine review of QC test data and related documents for in-process samples, ... goods and stability samples. + Monitor and trend QC data results + Follows established procedures and documents all...Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits + Assessment of GMP… more
- Prime Matter Labs (Torrance, CA)
- …maintain supplier quality assurance programs aligned with FDA, ISO 22716 ( GMP for cosmetics), and other applicable regulations. Conduct supplier audits, assessments, ... Collaborate with cross-functional teams to support continuous improvement initiatives. Develop, Review , Write, and Implement SOP's for quality functions and ensure… more
- Bristol Myers Squibb (Seattle, WA)
- …a strong technical background in automation design, development, and deployment within both GMP and non- GMP labs . This individual will foster effective ... and experienced Principal Engineer to join the Assay and Data Automation team. This role will lead the design,...automation platforms for bio-analytical methods that are performed in GMP and non- GMP labs . +… more
- Merck (Rahway, NJ)
- …capital projects, work to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off ... MES, Quality, and Batch Reporting applications. + Understand and adhere to CFR, GMP , and data integrity regulations to ensure compliance with regulatory… more
- Catalent Pharma Solutions (Harmans, MD)
- …from downtown Baltimore. The 200,000 sq. ft. Harmans/BWI-1 facility includes 10 GMP suites, fill/finish operations, testing labs , and warehousing, while the ... on-site** Catalent's Baltimore and Harmans, Maryland sites provide industry-leading GMP development and manufacturing services for advanced biopharmaceuticals, including… more
- Astrix Technology (Gardena, CA)
- **QA Data Clerk** Quality Assurance Gardena, CA, US + Added - 14/05/2025 Apply for Job Our Client, a fine chemical and laboratory products company, is seeking a QA ... Data Clerk to join their growing team. This is...into internal systems. No lab work. **Key Responsibilities:** + Review and process batch records (non-regulated to pharmaceutical-grade materials)… more
- Lilly (Indianapolis, IN)
- …control strategies are established for molecules they support. **Responsibilities:** + Technical review , interpretation, and release of data including data ... consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM...to CM laboratories or to designated third party QC labs . + Monograph review and implementation +… more
- Merck (Durham, NC)
- …an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs , various other manufacturing buildings and Maintenance and Material Storage Facility ... to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns + Coordinates with Site Engineering… more
- Genentech (South San Francisco, CA)
- …activities and documentation such as system risk assessments, decommissioning, and periodic review ; serving as department SME for data migration and archival; ... and related software will be used to support the daily operations and GMP compliance of our state-of-the-art analytical labs and instruments. **Who You… more
- Lilly (Lebanon, IN)
- …training and development of staff + Maintain a safe work environment + Ensure GMP compliance + Ensure technical review and approval for documents, including ... to build the processes and facility to enable a successful startup into GMP manufacturing operations._ **Main Purpose and Objectives:** The Senior Director - Quality… more
- Genentech (Oceanside, CA)
- …performing inventory checks and stocking supplies as needed (eg, preparing reagents). + Investigation and Data Review : Assist in data trending and data ... Opportunity** + Compliance and Quality System Adherence: Apply advanced knowledge of GMP , GDP, and Data Integrity ALCOA principles daily. Follow established… more
- Lilly (Indianapolis, IN)
- …cleaning related SOPs, instructions, and other related documentation, ensuring adherence to data integrity principles. + Review and approve all change controls ... the scientist will guide equipment and cleaning agent selection, establish GMP -compliant procedures, and collaborate with key stakeholders to transition the site… more
- Kelly Services (Lancaster, SC)
- …and optimization of analytical methods for complex formulations in a GMP -regulated environment. This role requires a deep understanding of laboratory ... Evaluate testing methodologies and results, including those from external contract labs . + Troubleshoot and maintain advanced analytical instrumentation (HPLC, GC,… more
- Curia (Springfield, MO)
- …author, and review SOPs, reports, protocols, investigations, change controls, and data summaries. Understand and use basic risk assessment and root cause tools + ... more! Essential job duties + Perform complex testing and data evaluation such as TGA + Perform complex Liquid/Gas...updates, etc. + Coordinate testing performed at outside testing labs , raw materials, etc. + Maintain a detailed and… more
- Curia (Albuquerque, NM)
- …interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and ... approval of environmental and microbiological test results including contract labs to support lot disposition and deliverables as prioritized...monitoring systems and equipment + Ensures proper recording and review of data + Test the integrity… more
- Merck (West Point, PA)
- … data -based Automation control systems Preferred + Familiarity with GMP /GXP environments and associated compliance expectations for commissioning protocols + ... for recurring tasks to improve team productivity, inclusive of data governance dashboards, data connector pathways, Key...Communicate and cascade updates to all user groups + Review , update, and approve procedural guidance updates for the… more
