- Twist BioScience (South San Francisco, CA)
- …scalability, maintainability, and alignment with biomanufacturing strategy, GxP regulations , industry best practices, and technological advancements in biotechnology ... Validation: Ensure our custom MES solutions comply with GxP regulations (eg, cGMP, GLP), FDA 21 CFR Part 11,...technologies (eg, SQL Server, Oracle, PostgreSQL).Extensive knowledge of GxP regulations (especially cGMP), FDA 21 CFR Part 11, and… more
- Aequor (San Diego, CA)
- …hires and updates to existing employees; stays current on updates to I-9 regulations ; audits and maintains I-9 binders as required to ensure compliance, shares ... I-9 documentation and maintenance Familiarity with state and federal employment regulations Proficiency in using the latest versions of Microsoft Office including… more
- Aequor (South San Francisco, CA)
- …negotiations and execution Ensure compliance with company policies and legal regulations Manage vendor and client relationships Develop and improve contract ... Strong problem-solving skills Excellent communication abilities Knowledge of industry regulations Preferred (Optional) Certification in contract management preferredHybrid -… more
- Insmed Incorporated (San Diego, CA)
- …they will be responsible for guiding strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the ... Global regulatory strategyIn-depth knowledge and direct application of US/EU/Japan/International regulations , regional guidance documents and ICH guidance documentsRegulatory writing… more
- Insmed Incorporated (San Diego, CA)
- …with applicable international and national standards, regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and ... activities are conducted, and reports written according to SOPs and regulations .Oversee GCP activities (including internal or external audit observations and… more
- Aequor (Vacaville, CA)
- …the performance of direct materials testing in accordance with cGMP regulations . These duties include execution of laboratory testing, trend analysis, documentation ... review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals. Job Responsibilities Perform a broad variety of… more
- Aequor (Irvine, CA)
- …Familiarity with medical device complaint files and quality records Knowledgeable of FDA regulations , 21 CFR part 820 and Part 803 and ISO 13485 standard Strong ... computer skills (including Excel) Demonstrated written and verbal communication skills Comments for Suppliers: more
- Novo Nordisk Inc. (Corona, CA)
- …or any other characteristic protected by local, state or federal laws, rules or regulations . If you are interested in applying to Novo Nordisk and need special ... assistance or an accommodation to apply, please call us at ###. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. more
- Lundbeck (Oakland, CA)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED ... EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must demonstrate the… more
- Repligen (Rancho Dominguez, CA)
- …implement process improvements, ensuring compliance with industry standards and regulations . Develop and maintain engineering documentation including test protocols, ... change controls, and technical reports. Guide the integration of new products and manufacturing processes, supporting early-phase development through commercialization. Mentor junior team members and support standardization and training of best practices.… more
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