Auditor, Batch Release

International Vitamin Corporation•AND-Anderson, SC

1d•Onsite

About The Position

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. Shift: Monday - Friday 8:30am - 5:00pm

Requirements

High school diploma or equivalent
1 years’ documentation, regulatory or office administration experience
1 years’ experience in a cGMP regulated or similar manufacturing environment
Proficient with software programs including Microsoft Word, Microsoft Excel, and Microsoft Outlook
Knowledge of electronic database (MasterControl) that manages deviations, CAPAs and material reviews
Knowledge of inventory or resource planning system MAPICS and Oracle
Must be able to interpret specifications and operational records
Highly organized individual with excellent written communication skills
Ability to interact with various departments and skill levels in a professional and consistent manner.
Excellent English and Math skills
Self-motivated individual and able to work with limited supervision
Knowledge and experience in cGMP / FDA regulations

Nice To Haves

Auditing exposure in a food, nutraceutical, pharmaceutical or government regulated industry is desired

Responsibilities

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 delays
Audits 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 regulations
Strive to improve process inefficiencies to maintain batch records to improve efficiencies
Ongoing maintenance of record retrieval system in tandem with QSC staff
Become knowledgeable in all manufacturing processes for Packaging at the Anderson facility.
Reviews the packaging records at all stages
Complies with “Right the First Time” metrics established in the organization
Exercise 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 pace
Defines problems, and collects data; establishes facts and draws valid conclusions
Performs 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 measures
Applies principles of logical or scientific thinking with a wide range of intellectual and practical problems
Create charts and provide tracking for batch record issues
Provides cGMP observations to management; presents information to employees and management