- Danaher Corporation (Coralville, IA)
- …accomplish great things. In this role, you will have the opportunity to: + The Manager , cGMP Quality Control supervises the internal and external Quality ... improve human health. This position is part of the Quality Control cGMP located in Coralville, IA...+ Author and execute standard operating procedures (SOP's) and validation procedures (IQ/OQ/PQ) for facility and production quality… more
- Fujifilm (College Station, TX)
- …nestled in the hub of innovation, representing a source of pride for the area. The Quality Assurance (QA) Manager , QA Validation , will be responsible for the ... review and approval of commissioning/qualification/ validation protocols, reports, and discrepancies. The Manager ...4+ years of supervisory experience. + 4+ years of cGMP experience. + Single Use and Process Validation… more
- ThermoFisher Scientific (Greenville, NC)
- …Practices (GMP) Safety Standards, Office **Job Description** **Job Summary:** The Senior Manager of QA Validation will provide oversight and manage the ... standards and align with regulatory requirements. The Senior Manager will lead a team professionals, drive validation...are in compliance with applicable regulatory requirements and internal quality standards ( cGMP , GxP, etc.). * Prepare… more
- PCI Pharma Services (Philadelphia, PA)
- …the future of PCI. Job Title: **Sterilization** ** Manager - Validation , Sterility Assurance, and Utilities/Facilities** Department/Group: Quality / ... By: Dennis Gerlach Approved By: Nancy Dorr **Summary of Objective:** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities is… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- Eurofins (Salt Lake City, UT)
- …areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Position Summary Eurofins BPT ... Sales Manager to join our team, focusing on facility validation and environmental monitoring solutions for the biopharmaceutical and medical device industries.… more
- Fujifilm (College Station, TX)
- …Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA ...and site SOPs to ensure regulatory compliance. **Reports to** Manager , QA Validation **Work Location** College Station,… more
- Fujifilm (College Station, TX)
- …in the hub of innovation, representing a source of pride for the area. The Quality Assurance (QA) Specialist II, QA Validation , under general direction, will be ... System improvements; Acting as a QA liaison internally. **Reports to** Manager , QA Validation **Work Location** College Station, TX **Primary… more
- PCI Pharma Services (Bedford, NH)
- …pioneer and shape the future of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process Validation Engineer III/IV is ... Validation (PV) and Revalidation (RV) in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. These Process… more
- PCI Pharma Services (Rockford, IL)
- …pioneer and shape the future of PCI. **Summary of Objective:** The Validation Engineer is responsible for the qualification/ validation of pharmaceutical ... testing, and packaging of medical devices. Core functions include management of validation projects, generation and execution of validation protocols, evaluation… more
- Danaher Corporation (Fargo, ND)
- …a part of the Process Validation team and report to the Process Validation Manager responsible for supporting internal and external validation projects. ... years of industry experience. + Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation... / Aseptic process simulation + Technical writing of quality records The salary range for this role is… more
- Danaher Corporation (Fargo, ND)
- …a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external validation ... experience in a life sciences company + Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and… more
- Fujifilm (College Station, TX)
- **Overview** + **_Summary_** **:** The Quality Assurance (QA) Supplier Quality manager will be responsible for leading the supplier quality team. The ... + Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial… more
- Catalent Pharma Solutions (Harmans, MD)
- The **Senior Manager , Quality Assurance Data Integrity Compliance** performs evaluation of internal controls, communications, risk assessments and maintenance of ... cGMP regulations, Catalent standards, and applicable regulatory requirements. + Resolves Quality Assurance issues complex in scope following cGMP regulations… more
- Arkema (Memphis, TN)
- …Facebook (https://www.facebook.com/ArkemaGroup) ,Instagram (https://www.instagram.com/Arkemagroup/) Job Segment: Quality Manager , Facilities, Compliance, ... Quality & Compliance Manager Job Location:...+ Develops and maintains API (Active Pharmaceutical Ingredient) product validation documentation. + Ensures sampling schedules are maintained. +… more
- Cardinal Health (Fort Lauderdale, FL)
- …and reports metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM). + Ensures the site manufactures products to meet ... the requirements of 21 CFR 212 ( cGMP ). + Handles and ensures quality of...Reports quality system issues to the Regional Quality Manager (RQM) and others as necessary.… more
- Merck (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing for the BCG vaccine. The Quality Operations Laboratory Manager leads a team of analysts in the ... Laboratory Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/… more
- ThermoFisher Scientific (St. Louis, MO)
- …asset and are passionate about cultivating and developing future talent! The QC Manager will lead the Quality Control Chemistry team, consisting of roles: ... analysis. **Preferred Qualifications:** + Expertise with method transfer and qualification or validation . + Knowledgeable in cGMP practices. + Strong background… more
- UCLA Health (Los Angeles, CA)
- …Director of GMP, Human Gene and Cell Therapy Facility (HGCTF), the QC Laboratory (Lab) Manager will lead the establishment of HGCTF ( cGMP ) QC lab including but ... Lab Manager will oversee technology transfer, method development, qualification/ validation and/or verification as per applicable guidelines. The QC Lab … more
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