Clinical Trial Manager / Senior Clinical Trial Manager

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Africa Center for Health Systems and Gender Justice, GIZ KE, International Rescue Committee, Plan International, World VisionProfession (Non-profit, social work)
Industry
Seniority (Non-profit, social work)
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Non-profit + 1 more
Description
Qualifications and Skills
- Diploma or certificate in a relevant technical, food-science, or engineering field (or equivalent hands-on experience).
- Prior experience operating grain-processing, sorting, or packaging machinery is an added advantage.
- Working knowledge of, or willingness to be trained on, GMP, food-safety, and basic statistical sampling (square-root method).
- High level of accuracy and attention to detail, particularly in reading gauges, recording data, and following numeric tolerances.
- Ability to work under pressure, follow LOTO and PPE requirements, and maintain composure during line stoppages.
- Comfortable using touch-screen machine interfaces and completing structured paper or digital log sheets.
- Good communication skills and ability to escalate issues promptly and clearly.
Responsibilities
Pre-Start, Start-Up & Machine Operation
- Carry out daily pre-shift inspection of all line equipment (air-screen cleaner, magnetic separator, de-stoner, gravity separator, grader, polisher, bagging scale) for damage, leaks, blockages, or worn parts before start-up.
- Follow lock-out/tag-out (LOTO) procedure whenever clearing blockages or working with guards removed.
- Confirm machine calibration status (scale, sorter/camera baseline, screen sizes) and load the correct recipe/settings for the grain variety being run.
- Start and run the line in the approved sequence, and maintain in-feed rate within the specified band per deck/hour to hold target throughput.
- Monitor touch-screen and gauge data continuously (rejection %, temperature, ejector frequency, aspiration pressure, wind pressure, amplitude) and adjust settings within permitted step-limits to keep the process on target.
- Track production and sorting data (e.g. batches run, throughput, bags produced) on Norming (the Sage ERP extension) as required, in addition to machine-level monitoring.
Quality Control, Testing & Sampling
- Perform the scheduled machine-level quality checks at the specified bag-count intervals for each unit, for example:
◦ Magnetic separator: daily 10/10 metal-catch pass test before production; metal-trap fullness checks at set times.
◦ De-stoner: 5 kg stone-count check (target: zero) and grain-loss check every 100 bags.
◦ Gravity separator: 100 g damaged/broken-kernel count (target <5) every 50 bags.
◦ Polisher: hourly bran-extraction check against the 0.4–0.7% target, with weight-in/weight-out records.
◦ Bagging/packing scale: daily zero calibration and 20-bag interval weight and seal-integrity checks.
- Apply the square-root sampling method for lot-level quality testing: draw n = √N increments across the shift lot, composite and quarter the sample, and submit for moisture, foreign-matter, damaged-kernel and (where applicable) aflatoxin testing.
- Quarantine and escalate to the QA Manager within 15 minutes whenever a test result falls outside specification, and hold the last 2×n bags until corrective action is confirmed.
- Escalate any deviation from target purity, weight, or rejection rate promptly, and support root-cause discussion on recurring quality issues.
Hygiene, Housekeeping & Safety
- Keep the sorting room and surrounding floor clean and free of dust and spillage throughout the shift; vacuum rather than use compressed air inside the sorting room.
- Run the end-of-shift flush and clean-down procedure (screens, pans, ejector valves, rollers, filters) and complete the hygiene checklist, including swab-test points where applicable.
- Manage bran and other combustible residues safely, and sweep/dispose of them at every break.
- Wear and correctly use all required PPE (hearing protection, dust mask, lock-out devices) at all times in the sorting room.
- Follow the applicable SOP guidelines in place for each machine/unit and each task (start-up, in-process control, sampling, clean-down), and escalate to the Supervisor/QA Manager if instructions are unclear or need updating.
Records & Reporting
- Complete all daily quality and machine logs accurately and on time, covering pre-shift checks, in-process test results, stoppages/downtime, and end-of-shift summaries for each unit on the line.
- Ensure all applicable quality and machine forms are fully filled out for every sorting run carried out during the shift, and retained for record-keeping purposes.
- Track and record all sorting and quality-check activity on Norming (the Sage ERP extension) as required, and attach or log the completed forms on Norming so that records are centrally retained and accessible.
- Prepare data and flag areas needing discussion ahead of Performance Dialogues, and report performance on the criteria/metrics defined for the role.
- Proactively share observations and suggested improvements to work instructions with the Supervisor/QA Manager.
Teamwork & Collaboration
- Build good working relationships with fellow operators, shift QC clerks, and maintenance staff to keep the line running smoothly.
- Help colleagues understand and safely follow work instructions, and support handover between shifts with a clear briefing.
- Contribute your own observations and be open to feedback and to trying improved ways of working.
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