Welcome page Returning Candidate? Log back in! Auditor, Batch Release Job Functional Area OPS - Quality Shift 1st Shift Overview

The Batch Release Auditor is accountable for ensuring the conformance of the packaging process to the current Good Manufacturing Practices (cGMPs), company policies and internal procedures.  Performs in process GMP audits, documentation review and final release of finished product that meets established specifications.

Responsibilities

STRATEGIC 

Partners with the departments to solve potential compliance issues in a proactive way to deliver product on time Establish recommendations and decisions to prevent process and/or product deviations; Failure to effectively perform this role could result in product recall and/or product delaysAudits all batch records prior to release and/or review necessary documents to support product; Release product to market that is compliant to internal, local, state and federal regulationsStrive to improve process inefficiencies to maintain batch records to improve efficiencies Ongoing maintenance of record retrieval system in tandem with QSC staff

TACTICAL 

Become knowledgeable in all manufacturing processes for Packaging at the Anderson facility. Reviews the packaging records at all stagesComplies with “Right the First Time” metrics established in the organizationExercise judgment on the resolution of production problems to meet company standards for quality, cost and critical factors; Make decisions and work with precision at a fast paceDefines problems, and collects data; establishes facts and draws valid conclusionsPerforms mathematical calculations: Adds and subtracts, divides all units of measures using whole numbers, common fractions, and decimals, calculates discounts profits and selling price and proportions, and percentage, calculates surfaces, volume weights, and measuresApplies principles of logical or scientific thinking with a wide range of intellectual and practical problemsCreate charts and provide tracking for batch record issuesProvides cGMP observations to management; presents information to employees and management

 

Qualifications High school diploma or equivalent1 years’ documentation, regulatory or office administration experience 1 years’ experience in a cGMP regulated or similar manufacturing environmentProficient with software programs including Microsoft Word, Microsoft Excel, and Microsoft OutlookKnowledge of electronic database (MasterControl) that manages deviations, CAPAs and material reviewsKnowledge of inventory or resource planning system MAPICS and Oracle Must be able to interpret specifications and operational recordsHighly organized individual with excellent written communication skillsAbility to interact with various departments and skill levels in a professional and consistent manner.Excellent English and Math skillsSelf-motivated individual and able to work with limited supervisionKnowledge and experience in cGMP / FDA regulationsAuditing exposure in a food, nutraceutical, pharmaceutical or government regulated industry is desired Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Application FAQs

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