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- ...assessments for change controls, deviations, audits, and contamination control initiatives. Participate in Environmental Control Network, Aseptic Council, and Contamination Control Network. Present EM/CU data and recommendations during Quality System forums and Management...SuggestedContract workWork at officeLocal areaShift work
- ...Participates in the surgical recovery of human tissue for transplantation. Demonstrates thorough knowledge and comprehension of aseptic technique. Demonstrates ability to circulate in an operating room setting. Inspect and monitor equipment, supplies, and instrumentation...SuggestedDaily paidWork at officeImmediate startShift workWeekend work
- ...Sterile Drug Delivery (or Spray Dry Dispersion) — sterile processing skids, isolators, filling/packaging lines; stringent GMP and aseptic-design controls in both vendor design and field install. OSD: Oral Solid Dosage — granulators, blenders, tablet presses, coaters...SuggestedContract workFor contractors
- ...validation programs and supporting regulatory inspections Technical Expertise Cleanroom and critical utility qualification Aseptic processing and sterilization validation Equipment commissioning and lifecycle validation Risk-based validation (ASTM E2500)...SuggestedContract workLocal areaFlexible hoursWeekend work
- ...areas (e.g., ISO 5–8). • Perform hands-on cleaning activities within cleanroom environments in accordance with cGMPs, SOPs, and aseptic practices. • Support cleaning validation activities, including execution of protocols, sampling activities, and documentation....SuggestedLocal area
Biosimilar Sciences PR LLC
Puerto Rico14 days ago - ...experience OR? Bachelor’s degree + 6 months of Quality work experience? OR Master's degree. Experience in plant quality assurance for aseptic areas focused on controls/techniques/behaviors and drug product formulation and filling. Experience in independent decision...SuggestedTemporary workWork experience placementLocal areaAll shiftsRotating shift
- ...Instrumentation/ Calibration to manage calibration program. Experience performing calibrations to Bioreactors, Utilities, Formulation, Aseptic Areas. Experience in Blue Mountain (RAM), Calman, or Procal Software is highly preferred. Must possess experience in:...Suggested
- ...expectations. Preferred Experience Experience with environmental monitoring programs. Experience validating cleaning procedures for aseptic or sterile manufacturing. Experience with CIP (Clean-In-Place) and COP (Clean-Out-of-Place) systems. Familiarity with TOC,...SuggestedWork at office
- ...complex technical documents when applicable. Provide hands-on support to sterile drug product manufacturing, including formulation, aseptic filling, and commercial process readiness. Support process characterization, technology transfer, PPQ/validation activities, and...SuggestedContract workWork at officeShift work
- ...industry are required. Minimum of one (1) year of experience in a chemical laboratory, microbiological assays sampling and usage of aseptic techniques is required. Basic computer skills and use of software applications is required. Knowledge of QSR's and ISO...SuggestedFull timeWorldwideShift workNight shiftWeekend workDay shiftAfternoon shift
$120k - $150k
...Experience supporting FDA audits and regulatory inspections. Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred. Required Qualifications Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical...SuggestedFor contractors- ...compliance with cGMP, safety, environmental, and company requirements. • Follow approved SOPs, work instructions, cleanroom gowning, aseptic practices, and safety procedures. • Support deviation investigations, root cause analysis, CAPAs, and change control activities....Suggested
- ...calibration activities. · Lead, supervise, and develop maintenance and calibration personnel. · Ensure maintenance teams are trained for aseptic interventions, cleanroom entry, gowning, and safety protocols. · Collaborate with Production, Engineering, Supply Chain, and QA...SuggestedWork at officeLocal area
- ...contamination control, and continuous improvement. Job Overview The Sterility Assurance Lead is accountable for ensuring that aseptic processing systems and sterility assurance controls are designed, implemented, monitored, and maintained in a validated state of...SuggestedLocal areaFlexible hoursWeekend work
- ...Ensure appropriate and correct use of applicable equipment for sample collection and delivery. Apply and assure appropriate aseptic techniques during all sampling activities. Ensure timely approval and reporting of applicable sampling results. Maintain appropriate...Suggested
- ...Engineering, Supply Chain, and Validation teams to support successful product introductions. Support transfer and scale-up activities for aseptic filling, formulation, filtration, and related manufacturing processes. Provide technical support for drug substance process...Work at officeLocal area
- ...Instrumentation/ Calibration to manage calibration program. Experience performing calibrations to Bioreactors, Utilities, Formulation, Aseptic Areas. Experience in Blue Mountain (RAM), Calman, or Procal Software is highly preferred. Must possess experience in:...
- ...identity, strength, quality and purity. • May Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment; May perform aseptic processing related tasks. • Responsible for quality assurance oversight of routine production, packaging and shipping of...Contract workImmediate startShift workRotating shift
- ...Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry. Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support....
