- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy process development, manufacturing science, analytical development, and familiarity with GMP / FDA /ICH .Key Responsibilities Subject matter expert of QC ... shift in throughput and capacity Maintain current awareness of GMP /GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry...current awareness of GMP /GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends that apply to… more
- DivIHN Integration Inc (Research Triangle Park, NC)
- …and thermal mapping activities comply with relevant industry regulations (eg, USP, NIST, FDA , GLP, GMP ). Minimum Requirements High School Diploma and 9 years ... methodology and tolerances. Experience working with loop calibrations. Understanding of FDA and GxP regulations and requirements. Experience working in GMP… more
- Compunnel (Carlsbad, CA)
- …to accurately record information within documentation while maintaining strict adherence to FDA , GMP and ISO requirements. The incumbent will perform daily ... housekeeping of the production areas and equipment as required. The Production Technician will be required to maintain up to date training records, support training of new employees and comply with all company policies and procedures. Teamwork, attendance and… more
- Careers Integrated Resources Inc (Eugene, OR)
- …teams to implement corrective and preventive measures. . Proven knowledge of ISO/ FDA , GMP , ISO Regulations and other regulatory requirements for diagnostics ... manufacturing. . Control all documentation relative to the operations planning function. Such documentation includes but is not limited to, backlog reports, lead-time analysis, shop floor orders (including rework orders), delivery performance, daily production… more
- ConsultNet (Beaverton, OR)
- …with bioinformatics and statistical software. Regulatory Knowledge: Familiarity with CLIA, FDA regulations, and GMP standards. Publication Record: Published ... for innovating and developing novel laboratory assays, ensuring they align with GMP and CLIA regulations. Partnering closely with the leadership team, including the… more
- Novo Nordisk Inc. (Boulder, CO)
- …management experience A deep understanding of and ability to apply of GMP /ICH/ FDA regulations to process development strategies for Oligonucleotide based drugs ... The base compensation range for this position is $150,000 to $185,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term… more
- Mastech Digital, Inc. (Lancaster, SC)
- …using statistical techniques, and review laboratory data for accuracy.- Ensure adherence to FDA , ICH guidelines, and GMP /GLP standards.- Mentor and train junior ... troubleshooting.- Knowledge of industry regulations and experience in a GMP environment is preferred.Education: Bachelor's degree in Analytical Chemistry,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the 8 years must include MSAT experience.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in ... plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities… more
- OSI Group (Oakland, IA)
- …in quality assurance and/or regulatory leadership - preferred. Knowledge of GMP /USDA/ FDA regulations Previous people leadership roles with multi-shift direct ... reports Progressive leadership roles within quality organizations with proven track record of success. Strong leadership and communication skills with demonstrated team building success. Has a passion for building, developing and leading strong diverse teams.… more
- Alpha Baking (Chicago, IL)
- …for all employees, adhering to industry sanitation standards, and ensuring compliance with FDA , SQF, HACCP, FSMA, and GMP standards. This position will report ... directly with Pest Control Provider. Conduct or take part in weekly plant GMP audit inspection. Ensure compliance with all relevant regulations, including OSHA, … more
- Elite Staffing Inc. (Alsip, IL)
- …a GMP environment Minimum High School, GED, or equivalent General Knowledge of GMP 's/SOP's and FDA regulations $19.50/hr Long Term 5pm to 4am Alsip, IL ... to. Job Duties: Monitor the production process to ensure compliance with GMP regulations, SOPs and Client's requirementsEnsure first Article (retain sample) is made… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience ... in supporting cell-based products as well as knowledge of Good Tissue Practices is a plus.Strong interpersonal and written/oral communication skills.Ability to quickly process complex information and often make critical decisions with minimal… more
- Alpha Baking (Chicago, IL)
- …and business needs. Regulatory Compliance: Thorough knowledge of food safety regulations (eg, FDA , USDA), quality standards (eg, GMP , HACCP), and industry best ... practices. Results Orientation: Strong business acumen, with a focus on achieving targets for production output, quality, cost control, and customer satisfaction. Problem-Solving Skills: Proactive approach to identifying challenges and implementing effective… more
- Careerbuilder-US (Glendale Heights, IL)
- …industry, preferably in spice manufacturing. Knowledge of food safety regulations ( FDA /USDA) & quality standards (SQF/HACCP/ GMP /FSVP/PCQI). Ability to assess ... Analysis & Critical Control Points (HACCP) and Good Manufacturing Practices ( GMP ), to prevent contamination and ensure product integrity. Oversee Foreign Supplier… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer is responsible for ensuring cGMP compliance of all relevant FDA regulations and internal procedures/specifications relating to oversight of engineering ... to document decisions and rationale. Data Integrity - assure GMP data captured and managed by engineering are handled,...Audits - represent the company during contact with the FDA and other regulatory agency audits. Data Management- perform… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …presented in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and ... of CMC changes and assess regulatory implications.- Participates in meetings with FDA . Prepares internal functional teams for these interactions to build strong… more
- Insmed Incorporated (San Diego, CA)
- …for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will have commercial ... GMP experience in supporting stability and sample management programs.ResponsibilitiesRepresentative...development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate to drug substance and drug… more
- Aequor (Thousand Oaks, CA)
- …safety, and 's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & ... experience in operations/manufacturing environment Direct experience with regulated environments ( FDA , OSHA, EPA, etc.) Working knowledge and experience with cGMP… 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 ... Work Experience: A minimum of five (5) years of GMP -related experience in a pharmaceutical or biotechnology company, with...a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible for the completion of QC testing ... is completed in compliance with all applicable procedures, standards and GMP regulationsWork with Process Development team, Quality and Operations organization to… more
