Overview:
Qualifications:
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 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
TACTICAL
- 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
Qualifications:
- 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
- Auditing exposure in a food, nutraceutical, pharmaceutical or government regulated industry is desired
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