Production Clerk

About the role

The Production clerk will be responsible for the maintenance and flow of Production documents as well as monitoring the accuracy and completeness to ensure compliance with cGMP and GDP guidelines and company policies. They will also review the batch records before submission to QC by ensuring that the documentation is free of errors is a key function of this position.

Responsibilities

• Examines batch record documentation and materials issuances, in order to assess completeness, accuracy, and conformance to cGMP and GDP standards and company policies.
• Able to navigate proficiently in ERP system to complete electronic folder reviews and confirm inventory adjustments are transacted appropriately.
• Maintains and records production data in the Daily Production Record (DPR) file including units produced, in-process rejects, QC samples, etc.
• While reviewing the batch record, tracks types of errors by the technicians, and works closely with Production management and technicians to eliminate reoccurrences.
• Update material issuances in the ERP system for the raw materials/components used during production.
• Other duties, as assigned.

Requirements

• High school diploma or equivalent.
• Some post high school education is desirable.
• 1 Year Previous Manufacturing / Quality experience in bioscience, pharmaceutical or medical devices industry.
• Working knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements.
• 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.
• Knowledge of weighing of materials and measuring volume in a manufacturing environment.
• 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.

Pay

For California, the base salary range for this position is $20.24 - $26.28 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off

Schedule

First Shift: 8:00 am-5 pm