QA | Santa Ana | CA
We are seeking an individual to handle the maintenance and flow of Production documents as well as monitor their accuracy and completeness for compliance with cGMP and GDP guidelines. Review of lot folders before submission to QA and ensuring that the lot folders are error free is a key function of this position. This individual is responsible for maintaining inventory of Production consumable items such as shoe covers, hairnets, lab coats, etc.
- Examines batch records documentation, materials, and monitors work processes, in order to assess completeness, accuracy, and conformance to cGMP and GDP standards and company policies.
- Reviews documents such as production schedules and work orders to ensure adequate supplies and materials for the day’s production.
- Maintains records production data in the Daily Production Record (DPR) file including units produced, in-process rejects, QC samples, etc.
- Requisitions and maintains inventories of materials and processing supplies necessary to meet production demands.
- Distributes production schedules and work orders to departments.
- While reviewing the batch record, tracks types of errors by the technicians, creates Prato charts, investigates root cause(s) and works closely with Production management and technicians to eliminate occurrence of those errors.
- Optimizes the batch record and production processes by proposing and submitting changes to the batch record and existing production SOPs.
- Work with the technicians on the production floor to observe their activities and provide feedback on their documentation method.
- High school diploma or equivalent. Some post high school education is desirable.
- Previous Manufacturing / Quality experience in bioscience, pharmaceutical or medical devices industry.
- Working knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements.
- Proficient in using computers.
- Working experience with ERP system.
- Working knowledge of batch records including GMP and GDP rules governing their accuracy and completeness.
- Knowledge of using computers and proficiency in MS Office Suite.
- Knowledge of Metric System.
- Weighing of materials and supplies in Production areas.
- Ability to learn processing methods that comply with current Good Manufacturing Practices (GMPs).
- Ability to speak and read English.
- Good oral and written communication skills.
To Apply: Please send resume to: firstname.lastname@example.org. Please put Production Clerk 112618 in the subject line.
Principals only. No recruiters please.
Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.