- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Job Summary:Accountable to manage and oversee QA GMP activities pertinent to commercial and Investigational Medicinal Products (IMP) to ... incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...for materials handling and distribution.Ensure that all activities follow GMP regulations.Ensure that all project work is managed under… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... State and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment, and safety,… more
- Merck & Co. (Durham, NC)
- …last several years; currently Durham employs 1,000+ people.This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment and safetyTactical… more
- Eisai, Inc (Exton, PA)
- …planning changes to the Pilot Plant and LabsPartner with Site QA in the GMP validation of Lab automation.Document GMP documentation as per Exton SOPs.Partner ... with Infrastructure Services and IT Security for Infrastructure services such as network support, storage, IT security controls on all Lab PCs.Manage vendor relationships, including escalation.Manage specialized device lifecycle, including… more
- BioAgilytix (Boston, MA)
- …need them.We are seeking a highly organized and experienced Quality Assurance (QA) Manager with strong people management skills to lead our Boston team and ensure ... Good Clinical Laboratory Practice (GCLP) principles, and/or FDA Good Manufacturing Practice ( GMP ) and industry standards as they apply to the life sciences and… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Previous supervisory experience in a GMP -regulated manufacturing environmentSafety focus in daily workInstallation, operation, maintenance ... and/or troubleshooting experience with complex process and/or utility systemsExperience using electronic manufacturing systems (eg BMS, MES, SAP, Delta-V, etc.)Experience in critical feedback and coaching, conflict resolution, performance management… more
- Aequor (Seattle, WA)
- …and 2&plus years (or equivalent combination) experience within a regulated ( GMP ) biopharmaceutical, cellular therapy, or gene therapy organization. Experience in ... management of external contract testing is preferred. Knowledge of analytical method lifecycle, including assay qualification, transfer, validation and maintenance. Experience with implementing release methods in a commercial QC facility. Experience in cGMP… more
- Eisai, Inc (Nutley, NJ)
- …of Statistical Programming is preferred but not required.Knowledge of GCP/ GMP is preferred.Auditing experience is preferred but not required.Must have ... professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.Ability to Travel (approximately 10-20%). Location: Nutley (hybrid role) #LI-TS1 Eisai is an equal opportunity employer and… more
- Merck & Co. (Rahway, NJ)
- …maintenance and calibration data build, as well as other GMP operational readiness critical activities to enable facility startup.Post turn-over ... from project, it will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to… more
- Merck & Co. (Durham, NC)
- …lyophilizers, etc.).Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule ... performance objectives.Consults on an as-needed basis with next level manager on more complex decisions.Education Minimum Requirement:Bachelor's and/or Master's (or… more
- Aequor (Thousand Oaks, CA)
- Manager is requesting candidates college GPA in the supplier notes of the resume if the candidate is willing to disclose. 8-5pm - Fully Onsite Experience: Open to a ... and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable regulations and ... co-lead the deviation investigations management system. Ensure alignment with GMP regulations and organizational objectives in all investigation activities.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority ... Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority ... on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as...Work Experience: A minimum of five (5) years of GMP -related experience in a pharmaceutical or biotechnology company, with… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves ... and departmental metricsConsults on an as-needed basis with team lead (04)/next-level manager on more complex decisions and/or issues that impact other units with… more
- Merck & Co. (Rahway, NJ)
- …partnering with Biologics Analytical Research and Development method development GMP laboratories, complementary areas of Analytical Research and Development, ... within the framework of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in… more
- Merck & Co. (Millsboro, DE)
- …eTime, Inspire.Compose, review, edit institutional SOPs.Serve as the hiring manager and trainer for Animal Services Managers.Coordinate promotions, transfers, or ... welfare, management of controlled substances, quality control testing according to GMP standards, and emissions control (incinerator). -Ensure training of company… more
- Aequor (Thousand Oaks, CA)
- …resumes attached of a ideal candidate for this role NOTES FROM HIRING MANAGER : Looking for hands on *STRONG* engineer experience with proper training/ background in ... instruments, and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol… more
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