- CTG (Woodland, CA)
- …writing and revising MMRs and QOPs to ensure procedural accuracy and compliance with cGMP and ISO 13485 * Conduct initial review of completed batch records for Good ... Documentation Practices * Maintain accurate reporting and trending of on-time QC release and batch record right-first-time metrics **Requirements:** * 1+ years of experience in Manufacturing, Quality, and/or Document Controls * Ability to develop, update, and… more
- Charles River Laboratories (Hollister, CA)
- …completing all service and compliance documentation as required by company policy, cGMP and FDA. * Responsible for resolving client testing laboratory instrument ... service issues. **Job Qualifications** The following are **minimum qualifications** related to the **Instrument Field Support Specialist** for our Nexus Robot and Endosafe range: Qualification in Engineering, Chemistry, Microbiology, Biology or equivalent… more
- Curia (Camarillo, CA)
- …the site quality system to meet the regulatory expectations and cGMP requirements for various global regions. This position's responsibilities include leading ... the site Quality organization (QA & QC) by providing leadership and guidance in quality decision making. The QC laboratories include both the chemistry and microbiology teams. The Site Head of Quality is also responsible for directing and providing leadership… more
- Astrix Technology (Los Angeles, CA)
- …test, and sample products to ensure compliance with specifications, SOPs, FDA, and cGMP regulations. + Conduct inspections and generate QA reports. + Identify and ... report non-conformities, manage containment, and assist in line failure investigations. + Maintain up-to-date QA documentation and close out OTC orders. + Develop masters, manage retain samples, and analyze QA data. + Participate in cross-training within the… more
- EMCOR Group (Anaheim, CA)
- …power plants, Cogeneration facilities, manufacturing facilities, clean rooms, cGMP facilities and process systems for Pharmaceutical and microelectronics ... facilities is desired. Ability to produce a complete detailed estimate from incomplete design documents is preferred. **Compensation Range: $80,000 to $105,000.** **ESSENTIAL DUTIES AND RESPONSIBILITIES** Note: This is not intended to be neither a detailed nor… more
- Gilead Sciences, Inc. (Foster City, CA)
- …influence decisions at all levels. + Working knowledge of FDA, EMA, and cGMP standards for combination products. The salary range for this position is: $210,375.00 ... - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP ). + Knowledge of and compliance with applicable Quality System requirements ... (eg, traceability QSRs, ISO and MDD requirements.) and other applicable regulations, + Experience in Program Management, use of Gantt Charts or Smartsheet. + Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus. + Must be able to lift… more
- Gilead Sciences, Inc. (Foster City, CA)
- …drugs and other co-meds for clinical studies . Mature knowledge of the FDA, cGMP , GCP standards and regulatory guidance documents such as CFR, Annex 13. . Possess ... strong clinical supplies management experience/ knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations . Possesses… more
- Herbalife (Lake Forest, CA)
- …Collection systems + Complete and maintain all necessary documentation including applicable cGMP documents + Complete PMs and WO documentation on CMMS + Identify ... occupational hazards and corresponding safety precautions necessary for the safe performance of assigned duties including lock out tag out procedures + Ability to be flexible with work schedule and willing to work overtime as needed + Execute production lines… more
- BioLife Plasma Services (Victorville, CA)
- …must also maintain complete and accurate records, in accordance with cGMP . **_ACCOUNTABILITIES_** + **Committed to meet customer service expectations (10%)** + ... Greet donors as they enter and exit the donor floor. + Answer phones within reasonable timeframe. + Maintain orderly filing system, purging records as needed. + **Perform all required duties in the area of** **Sample Processing** **(including, but not limited… more